Increasing Regulation for U.S. Foreign Investors

June 24th, 2015

The United States Department of Commerce Bureau of Economic Analysis (BEA) is authorized to conduct benchmark surveys of U.S. direct investment abroad every five years pursuant to the International Investment and Trade in Services Survey Act (P.L. 94-472, 90 Stat. 2059, 22 U.S.C. 3101-3108, as amended –hereinafter “the Act”).  Compliance with the benchmark survey, Form BE-10, has always been mandatory pursuant to the Act, but until November of 2014, it was only required of U.S. persons who received notices from the BEA.  However, following public notice on November 20, 2014 provided via publication in the Federal Registrar of the Final Rule by the BEA, the 2014 survey is now mandatory for all U.S. persons who fall under the specific foreign interest ownership threshold, including any person resident in the United States or subject to the jurisdiction of the United States.  The purpose of the Act is to authorize the President “to collect information on international investment and United States foreign trade in services, whether directly or by affiliates, including related information necessary for assessing the impact of such investment and trade, to authorize the collection and use of information on direct investments owned or controlled directly or indirectly by foreign governments or persons, and to provide analyses of such information to the Congress, the executive agencies, and the general public” (22 U.S.C. 3101).  More specifically, the President is to utilize the data collected “to determine the magnitude and aggregate value of portfolio investment, form of investments, types of investors, nationality of investors and recorded residence of foreign private holders, diversification of holdings by economic sector, and holders of record” (22 U.S.C. 3101).

Background

Form BE-10 can be seen as the latest in a long line of requirements arising out of the federal government’s emphasis on gathering information about U.S. taxpayers’ offshore economic activities.  While many laws requiring U.S. persons to report offshore economic interests have been on the books for decades, the government’s enforcement of these laws, and its effort to add new and stricter requirements, has been much more pronounced since revelations in 2007 that Swiss banking giant UBS had for years affirmatively engaged in efforts to assist U.S. taxpayers in evading their tax obligations under the veil of Swiss bank secrecy laws.  As a result, UBS was fined $780 million and the names of hundreds of UBS depositors were provided to the government.  (See the Department of Justice announcement here).  Since that time, the IRS and the Department of Justice have been active in prosecuting U.S. taxpayers for failing to report income from, or just the existence of, offshore bank and financial accounts and have been pursuing the identity of undeclared U.S. depositors with accounts in Switzerland, Israel, the Caribbean, and elsewhere.  (See related FIDJ blog post here).

Largely in response to the UBS case, Congress passed the Foreign Account Tax Compliance Act (FATCA) in 2010.  While much of the focus regarding FATCA has been centered on its requirement that foreign financial institutions provide information regarding U.S. account holders to the U.S. government or face automatic 30 percent withholding on all U.S. source payments, FATCA also included new filing requirements for U.S. taxpayers holding assets abroad.  In conjunction, the U.S. ramped up its enforcement of preexisting reporting obligations, such as the Foreign Bank Account Report (FBAR) obligation, discussed below.  As it is imperative that all U.S. persons with foreign interests familiarize themselves with the varied forms, the following is a brief summary of the forms and their applicable penalties:

U.S. Department of Commerce

Form BE-10 – Benchmark Survey of U.S. Direct Investment Abroad

Form BE-10A

Form BE-10A is a report that must be submitted by U.S. Reporters with foreign affiliates.  This includes any U.S person or entity, including private funds, which directly or indirectly owned or controlled at least 10 percent of the voting stock of an incorporated foreign business enterprise, or an equivalent interest in an unincorporated foreign business enterprise or fund – at any time during the entity’s 2014 fiscal year.  Irrespective of any equity (financial) interest in the foreign business enterprise, U.S. private fund parents with at least 10 percent voting interest in a foreign business enterprise are required to report.  If the U.S. person is an incorporated business enterprise, the U.S. Reporter is considered the fully consolidated U.S. domestic enterprise excluding foreign branches and all other foreign affiliates.

Form BE-10B

Form BE-10B must be submitted by U.S. Reporters for each foreign affiliate that is a majority-owned foreign affiliate with total assets, sales, or net income were greater than $80 million (positive or negative) during the 2014 fiscal year.

Form BE-10C

Form BE-10C must be submitted by U.S. Reporters for foreign affiliates that were (i) majority-owned foreign affiliates for which total assets, sales, or net income was greater than $25 million (positive or negative), and none of these items was greater than $80 million (positive or negative) at any time during the 2014 fiscal year; (ii) minority-owned foreign affiliates for which total assets, sales, or net income was greater than $25 million at any time during the 2014 fiscal year; or (iii) foreign affiliates for which total assets, sales or operating revenue did not exceed $25 million (positive or negative) at any time during the 2014 fiscal year and that is a foreign affiliate parent of another foreign affiliate being filed on Form BE-10B or BE-10C.

Form BE-10D

Form BE-10D must be submitted by U.S. Reporters for each foreign affiliate for which assets, sales, and net income did not exceed $25 million (positive or negative) at any time during the 2014 fiscal year and the affiliate is not a foreign affiliate parent of another foreign affiliate being filed on Form BE-10B or BE-10C.

The deadline to file the BE-10 reports for U.S. Reporters with fewer than 50 reports was May 29, 2015 and the deadline for U.S. Reporters with more than 50 reports is June 30, 2015.  The deadline for first time filers, however, has been extended to June 30, 2015.  An extension may also be granted by the BEA for those who file a Request for Extension if the request is filed prior to the applicable reporting deadline.  Failure to file the BE-10 report shall subject the U.S. Reporter to a civil penalty of not less than $2,500, and not more than $25,000, and to injunctive relief commanding such person to comply, or both.  A willful failure to report shall be fined not more than $10,000 and, if an individual, may be imprisoned for not more than one year, or both.  Similar fines and/or imprisonment may also be imposed on any convicted officer, director, employee, or agent of any corporation who knowingly participates in such violations (22 U.S.C. 3105), subject to inflationary adjustments.

Form BE-13 – Survey of New Foreign Direct Investment in the United States

On November 21, 2014, just one day following public notice of the new mandatory requirements for Form BE-10, the BEA announced on its website that the survey of new foreign direct investment (Form BE-13) was being reinstated and would also be required of all U.S. entities subject to the reporting requirements, regardless of whether they are contacted by the BEA or not.  The BEA announcement states that Form BE-13 “captures information about new investments made when a foreign investor establishes or acquires a U.S. business (either directly, or indirectly through a U.S. business it already owns) or expands an existing U.S. business.”

Form BE-13A

Form BE-13A must be submitted for a U.S. business enterprise when a foreign entity acquires a voting interest (directly, or indirectly through an existing U.S. affiliate) in that enterprise, segment, or operating unit and (i) the total cost of the acquisition is greater than $3 million, (ii) the U.S. business enterprise will operate as a separate legal entity, and (iii) by this acquisition, at least 10 percent of the voting interest in the acquired entity is now held (directly or indirectly) by the foreign entity.

Form BE-13B

Form BE-13B must be submitted for a U.S. business enterprise when a foreign entity, or an existing U.S. affiliate of a foreign entity, establishes a new legal entity in the United States and (i) the projected total cost to establish the new legal entity is greater than $3 million, and (ii) the foreign entity owns 10 percent or more of the new business enterprise’s voting interest (directly or indirectly).

Form BE-13C

Form BE-13C must be submitted for an existing U.S. affiliate of a foreign parent when it acquires a U.S. business enterprise or segment that it then merges into its operations and the total cost to acquire the business enterprise is greater than $3 million.

Form BE-13D

Form BE-13D must be submitted for an existing U.S. affiliate of a foreign parent when it expands its operations to include a new facility where business is conducted and the projected total cost of the expansion is greater than $3 million.

Form BE-13E

Form BE-13E must be submitted for a U.S. business enterprise that previously filed a Form BE-13B or BE-13D indicating that the established or expanded entity is still under construction.

Form BE-13 is due no later than 45 days after the reportable acquisition is completed, the new legal entity is established, or the expansion is commenced.  Failure to report may subject the U.S. Reporter to a civil penalty of not less than $2,500, and not more than $32,500, and to injunctive relief commanding such person to comply, or both.  Willful failures to report shall be fined not more than $10,000 and, if an individual, may be imprisoned for not more than one year, or both.  Similar fines and/or imprisonment may also be imposed on any officer, director, employee, or agent of any corporation who knowingly participates in such violation, subject to inflationary adjustments.  Claims for Exemption from Form BE-13 may be filed for U.S. business enterprises that meet all of the requirements for filing Forms BE-13A, BE-13B, BE-13C, or BE-13D except the $3 million reporting threshold.

Form BE-12 – Benchmark Survey of Foreign Direct Investment In The United States

Form BE-12 is a benchmark survey of foreign direct investment in the U.S. conducted every five years in lieu of the Annual Survey, described below.  Form BE-12 applies to any U.S. entity in which foreign investors hold at least 10 percent of the voting interests at the end of the reporting calendar year where the entity’s total revenue, total assets, or net income exceeds $60 million.  A Claim for Not Filing may be filed for Form BE-12 if (i) a foreign person did not own 10 percent or more of the voting ownership (or the equivalent) in the U.S business enterprise, (ii) the U.S. business enterprise is fully consolidated or merged into another U.S. affiliate, or (iii) the U.S. business enterprise was liquidated or dissolved.  This survey was recently completed in 2012 and will not be issued again until 2017.

Form BE-12A

Form BE-12A must be submitted for a majority-owned U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $300 million (positive or negative).

Form BE-12B

Form BE-12B must be submitted for (i) a majority-owned U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $60 million (positive or negative), but no one of these items was greater than $300 million (positive or negative), and (ii) a minority-owned U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $60 million (positive or negative).

Form BE-12C

Form BE-12C must be submitted for a U.S. affiliate for which no one of these items was greater than $60 million (positive or negative): total assets, sales or gross operating revenues, and net income.

Form BE-577 – Quarterly Survey of U.S. Direct Investment Abroad required only for those directly contacted by BEA.

Form BE-577 should be submitted for (i) each directly-owned foreign affiliate for which total assets; annual sales or gross operating revenues, excluding sales taxes; or annual net income after provision for foreign income taxes was greater than $60 million (positive or negative) at any time during the affiliate’s fiscal reporting year, and (ii) each indirectly-owned foreign affiliate that met the $60 million threshold and had an intercompany debt balance with the U.S. reporter that exceeded $1 million.  Entities not contacted by BEA have no reporting responsibilities.

Form BE-11 – Annual Survey of U.S. Direct Investment Abroad required only for those directly contacted by BEA.

Form BE-11A

Form BE-11A should be submitted for the fully consolidated U.S. domestic business enterprise of a U.S. reporter that has a reportable foreign affiliate.

Form BE-11B

Form BE-11B should be submitted for a majority-owned foreign affiliate with total assets, sales or gross operating revenues, or net income greater than $60 million (positive or negative).  If the majority-owned affiliate is a foreign affiliate parent of another foreign affiliate being filed on Form BE-11B or BE-11C, Form BE-11B must be filed for the foreign affiliate parent even if total assets, sales or gross operating revenues, or net income did not exceed $60 million (positive or negative).

Form BE-11C

Form BE-11C should be submitted for a minority-owned foreign affiliate with total assets, sales or gross operating revenues, or net income greater than $60 million (positive or negative).  If the minority-owned affiliate is a foreign affiliate parent of another foreign affiliate being filed on Form BE-11C, Form BE-11C must be filed for the foreign affiliate parent even if total assets, sales or gross operating revenues, or net income did not exceed $60 million (positive or negative).

Form BE-11D

Form BE-11D should be submitted for a foreign affiliate established or acquired during the fiscal year with total assets, sales or gross operating revenues, or net income greater than $25 million (positive or negative), but for which no one of these items was greater than $60 million (positive or negative) at the end of, or for, the affiliate’s fiscal year.

Form BE-605 – BEA’s Quarterly Survey of Foreign Direct Investment in the U.S. required only for those directly contacted by BEA.

Form BE-605 should be submitted for every U.S. affiliate for which total assets, annual sales, or gross operating revenues, OR annual net income (not just the foreign parent’s share) were greater than $60 million (positive or negative).  Reports are required even though the U.S. business enterprise may have been established, acquired, liquidated, sold, or inactivated during the reporting period.  Entities not contacted by BEA have no reporting responsibilities.

Form BE-15 – BEA’s Annual Survey of Foreign Direct Investment in the U.S. required only for those directly contacted by BEA.

Form BE-15A

Form BE-15A should be submitted for a majority-owned (exceed 50 percent) U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $300 million (positive or negative).

Form BE-15B

Form BE-15B should be submitted for 1) a majority-owned (at least 10 percent, but not more than 50 percent) U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $120 million (positive or negative), but no one

of these items was greater than $300 million (positive or negative) and, 2) a minority-owned U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $120 million (positive or negative).

Form BE-15C

Form BE-15C should be submitted for a U.S. affiliate with total assets, sales or gross operating revenues, or net income greater than $40 million (positive or negative), but none of these items was greater than $120 million (positive or negative).

Form BE-9 – Quarterly Survey of Foreign Airline Operators’ Revenues and Expenses in the United States required only for those directly contacted by BEA

Form BE-9 is mailed to about 50 persons each quarter.  This quarterly survey collects data from U.S. offices, agents, or other representatives of foreign airline operators that transport passengers or freight and express to or from the United States.  A report is required if the carrier’s total covered revenues or total covered expenses were $5 million or more in the previous year or are expected to be $5 million or more during the current year.

Form BE-29 – Annual Survey of Foreign Ocean Carriers’ Expenses in the United States required only for those directly contacted by BEA

Form BE-29 is mailed to about 85 persons each year.  This annual survey collects data from U.S. agents of foreign ocean carriers who must report all relevant transactions in port services provided by them or obtained by them for foreign carriers and on port services provided by third persons.  A report is required if the U.S. agent handled at least 40 port calls by foreign vessels and if total covered expenses were $250,000 or more in the reporting period.

Form BE-30 – Quarterly Survey of Ocean Freight Revenues and Foreign Expenses of United States Carriers required only for those directly contacted by BEA

Form BE-30 is mailed to about 25 persons each quarter.  The quarterly survey collects data from U.S. airline operators engaged in the international transportation of U.S. export freight and the transportation of freight and passengers between foreign points.  A report is required if the U.S. airline operator’s total covered revenues or total covered expenses were $500,000 or more in the previous year or are expected to be $500,000 or more in the current year.

BE-180 – Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons required only for those directly contacted by BEA

Form BE-180 was mailed to about 6,200 firms in 2009.  The benchmark survey covers financial services transactions (including, payments to, and receipts from) affiliated and unaffiliated foreign persons.  A report is required if in the fiscal year covered by the survey, the U.S. person transacted with a foreign person in any of the covered financial services.  The U.S person is required to provide detailed information by type of service and by country if the U.S person had more than $3 million of receipts or payments in all financial services combined.  If the U.S. person’s total transactions fell below the threshold, estimates of total receipts and total payments must be provided.  In addition, the U.S. person is asked, but not required, to provide an estimate of the total transactions for each type of financial service.

Form BE-185 – Quarterly Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons required only for those directly contacted by BEA

Form BE-185 is mailed to about 675 firms each quarter.  This quarterly survey covers payments to, and receipts from, affiliated and unaffiliated foreign persons.  A report is required if a U.S. person had (i) receipts from affiliated and unaffiliated foreign persons for all financial services combined of more than $20 million in the previous fiscal year or expects to have receipts of more than $20 million in the current fiscal year or (ii) payments to affiliated and unaffiliated foreign persons for all financial services combined of more than $15 million in the previous fiscal year or expects to have payments of more than $15 million in the current fiscal year.

Form BE-140 – Benchmark Survey of Insurance Transactions by U.S. Insurance Companies With Foreign Persons required only for those directly contacted by BEA

Form BE-140 was mailed to about 1,100 firms in 2008.  This benchmark survey collects data from U.S. insurance companies that have engaged in insurance transactions with foreign persons during the reporting period.  A report is required if a U.S. insurance company had transactions in any of the covered items that were less than $2 million or were more than $2 million in the calendar year covered by the survey.

Form BE-45 – Quarterly Survey of Insurance Transactions by U.S. Insurance Companies with Foreign Persons required only for those directly contacted by BEA

Form BE-45 is mailed to about 550 firms each quarter.  This quarterly survey collects data from U.S. insurance companies that have engaged in insurance transactions with foreign persons during the reporting period.  A report is required if transactions in any of the covered items were less than $8 million or more than $8 million in the previous year or are expected to be in the current calendar year.

Form BE-120 – Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons required only for those directly contacted by BEA

Form BE-120 was mailed to about 14,500 persons in 2011.  This benchmark survey collects data from U.S. persons who had transactions (receipts and/or payments) with affiliated and unaffiliated foreign persons during the reporting period.  A report is required if the U.S. person transacted with a foreign person in any of the covered services during the fiscal year.  The U.S. person is required to provide detailed information by type of service and by country if the total transactions (affiliated and unaffiliated) in any of the categories exceeded $2 million for receipts or $1 million for payments.  If the U.S. person’s transactions fell below the threshold, estimates of total receipts and total payments must be provided.  In addition, the U.S. person is asked, but not required, to provide estimates of the total transactions for each type of service.

Form BE-125 – Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons required only for those directly contacted by BEA

Form BE-125 is mailed to about 2,000 persons each quarter.  This quarterly survey collects data from U.S. persons who had transactions (receipts and/or payments) with affiliated and unaffiliated foreign persons during the reporting period.  A report is required if a U.S. person had (i) receipts from affiliated and unaffiliated foreign persons in any of the covered categories of more than $6 million in the previous fiscal year or expects to have receipts of more than $6 million in the current fiscal year or (ii) payments to affiliated and unaffiliated foreign persons in any of the covered categories of more than $4 million in the previous fiscal year or expects to have payments of more than $4 million in the current fiscal year.

Form BE-150 – Quarterly Survey of Payment Card and Bank Card Transactions Related to International Travel

Form BE-150 is filed by all U.S. credit card companies and by debit networks that are based on personal identification numbers.  These companies are required to report (i) transactions between U.S. cardholders traveling abroad and foreign businesses and (ii) transactions between foreign cardholders traveling in the United States and U.S. businesses.

Internal Revenue Service

Form 926

Under Internal Revenue Code (IRC) §6038B, each United States person (generally defined for Form 926 and the other forms described herein as a citizen or resident of the United States, or a domestic entity (i.e. partnership, corporation, estate, or trust formed under the laws of the United States)) who transfers property to a foreign corporation in an exchange described in IRC §§332, 351, 354, 355, 356, or 361, or a corporation that makes a distribution described in IRC §336 (i.e. a liquidating distribution) to a non-U.S. person must report the transfer to the IRS on Form 926.  This provision is intended to provide the U.S. government with information regarding capitalization, liquidation, or reorganization of a foreign corporation in which a U.S. person holds an interest.

Any U.S. person who fails to provide notice of the transfers to foreign persons as described above may be liable for a penalty equal to 10 percent of the fair market value of the property transferred, valued at the time of the exchange.  The taxpayer may also be required to recognize gain on the transaction even if the transaction would have been a non-recognition event in the normal course.

Form 3520

U.S. persons must file Form 3520 to report certain transactions with foreign trusts, ownership of foreign grantor trusts, and receipt of certain large gifts or bequests from certain foreign persons.  A separate Form 3520 must be filed with respect to each foreign trust or gift.

Failure to file the form can lead to penalties equal to the greater of $10,000, 35% of the gross value of any property transferred to a foreign trust during the year, 35% of the gross value of the distributions received from a foreign trust during the year, or 5% of the gross value of the portion of the trust’s assets treated as owned by a U.S. person in a foreign grantor trust.

Form 3520-A

Form 3520-A is the annual information return of a foreign trust (i.e. a trust formed under the laws of a foreign country, and subject to the courts of a different country) with at least one U.S. owner.  The form requires submission of information about the foreign trust, its U.S. beneficiaries, and any “U.S. person”who is treated as an owner of any portion of the foreign trust.  A foreign trust with a U.S. owner must file Form 3520-A in order to satisfy their annual information reporting requirements under IRC §6048(b).

A U.S. owner is subject to an initial penalty equal to the greater of $10,000 or 5% of the gross value of the portion of the foreign trust’s assets treated as owned by the U.S. person at the close of that tax year, if the foreign trust does not timely file the form, or files an incomplete or incorrect form.

Form 5471

IRC §6046 requires each of the following to file Form 5471, setting forth certain information with respect to a foreign corporation:

  • Each United States citizen or resident who becomes an officer or director of a foreign corporation if a United States person own 10 percent or more of the total combined voting power of all classes of stock of the foreign corporation entitled to vote, or 10 percent or more the total value of the stock of the foreign corporation.
  • Each United States person who acquires stock and, either when added to any stock owned on the date of such acquisition or without regard to stock owned on the date of such acquisition, owns 10 percent or more of the total combined voting power of all classes of stock of a foreign corporation entitled to vote, or 10 percent or more the total value of the stock of a foreign corporation.
  • Each person who is treated as a United States shareholder under IRC §953(c).
  • Each person who becomes a United States person while owning 10 percent or more of the total combined voting power of all classes of stock of a foreign corporation entitled to vote, or 10 percent or more the total value of the stock of a foreign corporation.

In determining ownership percentages, complex rules regarding attribution of ownership from family members or related entities apply, creating a trap for unwary taxpayers who look only to interests held in their name in determining their reporting obligations.  Form 5471 must be filed for each foreign corporation that gives rise to a reporting obligation.  Failure to file Form 5471 may lead to penalties of $10,000 for each failure.  Further, failure to file the form may compromise opportunities to take advantage of the foreign tax credit and may lead to criminal prosecution.

Form 8621

U.S. persons holding interests in passive foreign investment companies (PFICs) must report such interests, as well as any PFIC distributions, each year on Form 8621.  PFICs are foreign corporations whose assets are primarily devoted to the generation of passive income (interest, dividends, etc.).  A separate form must be filed for each PFIC in which the U.S. person has an interest.  Furthermore, PFIC distributions, i.e. dividends or dispositional gains, are taxed differently (and more punitively) than typical dividends or capital gains.

Form 8865

If a U.S. person holds an interest in a foreign partnership, there is good chance that person will have to file Form 8865.  The form is used to report the information required under IRC §6038 (reporting with respect to controlled foreign partnerships—where U.S. persons own more than 50 percent of the partnership), IRC §6038B (reporting of transfers to foreign partnerships), and IRC §6046A (reporting of acquisitions, dispositions, and changes in foreign partnership interests).  Form 8865 sets forth several categories of interest holders who must file the form and requires different schedules, statements, and information, depending on the category of filer.  As with the other forms discussed, failure to file a timely and accurate Form 8865 may lead to penalties of $10,000 for each failure and may lead to criminal prosecution.

Form 8938

Pursuant to IRC §6038D, any U.S. person who, during any taxable year, holds a specified interest in a specified foreign financial asset is required to attach to his individual income tax return (i.e. Form 1040), specific information regarding those assets on Form 8938.  While the filing thresholds for Form 8938 can be quite complex, generally U.S. persons living in the U.S. must file Form 8938 if their offshore financial assets (bank accounts, investment accounts, interests in foreign entities, and most other financial assets) exceeds $50,000 for a single tax return filer and $75,000 for joint tax return filers.  These thresholds rise when the U.S. taxpayer resides abroad.  Failure to file Form 8938 may lead to penalties of $10,000 per failure and criminal penalties.  Form 8938 in many circumstances is redundant with the FBAR filing obligation, but filing Form 8938 does not relieve the FBAR filing obligation, and vice versa.

FinCEN Form 114 (FBAR)

FBARs must be filed by any U.S. person that has signatory authority over, or a financial interest in, a foreign bank account(s) with a value exceeding $10,000 at any time during the preceding taxable year.  A financial interest means a person that is either the legal title holder of the account or someone who can (either independently or in conjunction with another) direct the disposition of the account assets.  The $10,000 threshold cannot be circumvented by keeping multiple accounts; all account values are aggregated.  While most of the forms discussed above are required to be filed with a taxpayer’s tax return (except for 3520 and 3520-A, which must be filed separately with the Ogden, Utah IRS service center), the FBAR must be filed online with the Bank Secrecy Act’s e-filing website, and is due by June 30 for the previous taxable year (i.e., FBARs for 2014 are due on June 30, 2015).

A $10,000 penalty is imposed for non-willful failures to file an FBAR.  For willful failures, the penalties can reach 50% of the maximum account value each year.  Strict application of this rule can lead to penalties far in excess of the account value.  Schedule B of Form 1040 requires taxpayers to affirmatively state whether they had a financial interest in, or signatory authority over, a foreign bank account during the previous year.  The presence of that question, no matter how it is answered, severely hurts any argument that a failure to file an FBAR was not willful.  (See related FIDJ FBAR blog posts here).

Other Penalties

In addition to giving rise to independent monetary penalties, failure to file Forms 5471, 3520, 3520-A, 926, 8938, or 8865 will extend the statute of limitations for making an assessment of tax with respect to the entire return, whether or not the assessed deficiency relates to the unfiled form.  IRC § 6501(d)(8).  Further, if there is a deficiency that arises out of income relating to an unfiled form, a penalty of 40% can be assessed in addition to the deficiency.  IRC § 6662(j).

Given the overlap of the various filing requirements, failing to abide by these filing requirements in just a single year can lead to huge penalties or worse.  For instance, if a taxpayer has a single offshore investment account with $400,000 in it, he will have to file an FBAR, a Form 8938, and, in some circumstances, a Form 8621 to report interests in PFICs.  Failure to do so in just a single year gives rise to almost automatic penalties of $20,000, plus additional penalties if there is any unreported income attributable to the account.  Further, the statute of limitations for the entire return will not begin to run until all forms are filed.

Years of abuse by U.S. taxpayers of foreign bank secrecy laws coupled with an increased desire to generate revenue has led to the situation we are in today.  If a U.S. person has economic interests abroad, almost invariably they have an obligation to report the interest, often on more than one form.  As shown by Form BE-10A, agencies beyond just the IRS or the Department of Treasury are beginning to impose reporting obligations with respect to foreign investment.  It is essential that taxpayers in that position seek experienced counsel to guide them through the various filing requirements.  The old adage “an ounce of prevention is worth a pound of cure” has never been more apt.

The attorneys at Fuerst Ittleman David & Joseph specialize in the complexities faced by U.S. taxpayers investing, operating business, or holding assets abroad, with a particular focus on the tax implications of those activities.  Please contact us by email at contact@fidjlaw.com or telephone at 305.350.5690 with any questions regarding this article or any other issues on which we might provide legal assistance.

FTC Advertising Law Update: FTC Issues Updated FAQs to Endorsement Guides

June 24th, 2015

On May 29, 2015, The U.S. Federal Trade Commission (“FTC”) issued an updated “Frequently Asked Questions” (“FAQs”) guide on advertisement endorsements. These FAQs include regulatory guidance on how endorsements may be made via social media. (To read the FTC’s announcement please click here.) Endorsements are advertising messages conveying third-party opinions or experiences and are used by advertisers to promote products or services to consumers. Like most advertising, endorsements are regulated by the FTC. The new FAQs, “What People Are Asking,” supplements FTC’s 2009 Endorsement Guide on the same subject in large to address social media advertising and address many of the same legal issues articulated in the 2009 Endorsement Guides. As made clear by FTC, first, all endorsements must meet the standard of “truthful and not misleading.” Second, disclosure of the relationship between the endorser and the company must be clear and conspicuous. Finally, if the endorser promotes an experience that is not backed by evidence or is not normally achieved, clear and conspicuous disclosure is needed. (To read the entire FAQs please click here.)

The FTC monitors the world of social media, including Facebook, Twitter, YouTube, and Instagram. Companies that promote products through the use of endorsements on social media must be acutely aware of how this type of advertising is regulated. The same Truth In Advertisinglaws that apply to traditional types of media such as television and magazines apply to social media as well. Per these laws, advertisements must be truthful, not misleading, and backed by evidence when appropriate. Companies engaging in a quid-pro-quo relationship with an endorser are subject to these same standards.

“What People Are Asking” is an updated compilation of answers to general questions the FTC has received since issuing the 2009 Endorsement Guides. The updated FAQs expand on topics previously addressed and offer advice on how to apply the Endorsement Guides to new forms of social media advertising. Here are a few points of emphasis:

  • The FTC “is only concerned about endorsements that are made on behalf of a sponsoring advertiser.” Therefore, endorsements not solicited or where no relationship exists between the endorsee and the endorser are not subject to FTC’s guides. However, if an endorser works for an advertiser or receives something in exchange for the endorsement, then the Endorsement Guides apply.
  • Social media platforms that allow individuals to “like” a product (i.e. Facebook) are not considered endorsement. However, a company buying fake “likes” could subject the company to enforcement action. Enforcement action may ensue from purchasing fake “likes” because advertisements account for a substantial portion of Facebook’s revenue, and if fake “likes” can be bought through a “click farm” the advertisement may be deemed to be deceptive and misleading and subject to an FTC enforcement action. (To read more on click farms please click here.)
  • Platforms with character limits (i.e. Twitter) are not exempt from disclosure. The FTC “isn’t mandating specific wording for [endorsement] disclosures,” but suggests supplementing the endorsement with a hashtag like “#ad” or “Promotion” would be sufficient.
  • YouTube is a platform that is primarily video based, and endorsements on YouTube must be clear and conspicuous. The FTC suggests multiple, periodic disclosures because a disclosure only at the beginning or end of the stream could easily be dismissed.
  • Endorsements must reflect the honest opinions or experiences of the endorser. Endorsers cannot talk about an experience with a product if they have not tried it, and they cannot write a positive review if they thought the product was terrible.
  • An employee of a company endorsing one of its products must disclose his/her relationship with the company.
  • Companies need to have reasonable programs in place to train and monitor members of their network of bloggers and social media promoters. These programs should include explaining proper disclosure, explaining what can and cannot be said about a product, and searching their social media network periodically to monitor and remove what is being said.

Advertising on the internet and through social media can be tricky. Not only should companies follow FTC’s guidances, companies should be aware of the Federal Drug Administration’s (“FDA”) internet presence. Along with the FTC, the FDA too scours the internet searching for companies who are  impermissibly promoting or advertising drugs, medical devices, and the countless other products which fall within the FDA’s jurisdiction. (To read the FDA’s draft guidance document Internet/Social Media Platforms please click here.)

The FTC closely monitors endorsements on the internet. Companies using endorsements through social media should be aware of how to comply with FTC’s guidances to avoid penalties. Companies can comply by abiding by the Truth In Advertising Laws, the 2009 Endorsement Guides, and the updated FAQs while using social media and a third party to promote their products. Companies should ensure their advertisements either published in-house, or through endorsements, abide by FTC’s regulations and guides.

Fuerst Ittleman David & Joseph, PL will continue to monitor any developments with the FTC’s Endorsement Guides. The attorneys in our Food, Drug, and Life Sciences practice group are experienced in assisting regulated industry to ensure that products are marketed and advertised in compliance with all applicable federal laws and regulations. For more information, please call us at (305) 350-5690 or email us at contact@fidjlaw.com.

White Collar Criminal Defense Update: Second Circuit Emphasizes Constitutional Right to Impartial Jury, Upholds High Standard to Prove Waiver

June 23rd, 2015

The Government must prove by a preponderance of the evidence that a defendant has waived his Sixth Amendment right to an impartial jury, which is a heavier burden than one might expect after the Second Circuit’s decision in United States v. Parse, available here. In Parse, after a juror revealed her hidden agenda, the District Court and the parties discovered multiple lies she concealed during voir dire and the trial. However, the District Court found that the criminal defendant’s (David Parse) attorneys knew, or should have known, about the lies based on previous research on the juror, and therefore concluded that Parse waived his right to an impartial jury. The District Court refused to grant his motion for a new trial despite granting it for his codefendants. The Second Circuit reversed and held that the District Court clearly erred when it refused to order a new trial after the juror’s strategic manipulation because such a refusal would seriously affect the “fairness, integrity, and public reputation of judicial proceedings” when there was no evidence proving the lawyers or Parse knew the juror was lying.

Background

Parse was a broker employed by an investment banking firm. He and others were indicted and charged with conspiracy to defraud the U.S. and to commit mail fraud, wire fraud, and tax evasion in violation of 18 U.S.C. § 371, among other tax-related offenses. He was tried along with his codefendants, and following the three-month trial the jury returned a split verdict for Parse. Parse was found guilty on substantive mail fraud and obstruction charges but not guilty on the four other counts against him.

Months after the verdict, all four codefendants moved under Federal Rule of Criminal Procedure 33for a new trial on the ground that Catherine M. Conrad, Juror No. 1, had lied and withheld information in voir dire and during the trial. These motions were sparked by a letter Conrad sent to the Government praising its work in the trial. She also told the Government that she had been holding out for days during deliberation trying to convince other jurors to convict Parse. After this letter, the subsequent motions, and an evidentiary hearing, the District Court released an opinion finding Conrad had “lied extensively during voir dire and concealed important information about her background.”

To begin, the only information Conrad revealed to the voir dire survey questions was that her father works as an immigration officer and that she was a plaintiff in a personal injury negligence case. She was silent as to questions about criminal history, relatives who are attorneys, and many other basic questions that would indicate bias. During individual questioning she also stated that she had lived at the same address her whole life and she was currently a stay-at-home wife with a college education. Among the lies the District Court discovered: Conrad’s occupation as a lawyer and subsequent suspension from the profession for professional misconduct, her multiple previous arrests for everything from shoplifting to DUI to aggravated harassment, her apartment located at a different address than she claimed, and her career criminal husband, who has been convicted of at least nine criminal offenses and incarcerated. During an evidentiary hearing Conrad also made multiple biased statements, such as “[Defendants are] fricken crooks and they should be in jail and you know that.” She also told the Court that she lied to make herself more “marketable” as a juror. The District Court found she was biased against the defendants and a pathological liar. The District Court then granted the codefendants’ motions for a new trial, but not Parse’s.

District Court’s Denial of a New Trial for Parse

In short, the District Court determined that Parse’s attorneys either knew, or should have known through due diligence, that Conrad was lying. Accordingly, the District Court ruled that Parse waived his constitutional right to an impartial jury. In support of its holding, the District Court cited several exchanges occurring before voir dire, during closing arguments, and after the verdict. First, it cited several email exchanges where Parse’s attorneys discussed Google searches that revealed information about a suspended lawyer who also went by the name Catherine M. Conrad. Parse’s attorneys felt it could not be the same person because it would have required blatant lying in voir dire, and therefore chose not to pursue it further. Next, the law firm disclosed further research conducted during closing arguments after Conrad had submitted a note to the Court. During that search, a paralegal discovered the Suspension Orders suspending Conrad from practicing law in New York in both 2007 and 2010. The paralegal also produced a Westlaw Report that contained information about Conrad’s previous address and her involvement in a civil lawsuit. Again, the team concluded it was “inconceivable” that Conrad lied during voir dire. Finally, after the post-verdict letter, another Google search matched Conrad’s telephone number to one associated with the suspended attorney, and that was the first time the attorneys said they really suspected it was the same person. A two-week investigation looking at property records, Conrad’s husband’s criminal records, and marriage records confirmed suspicions.

The District Court was displeased and asked the attorneys if the law firm would have ever disclosed their previous research and findings had the court/Government not inquired. The District Court based the attorneys’ supposed knowledge of Conrad’s lies on evidence such as an email exchange that occurred the same day jury deliberations began where a paralegal wrote, “Jesus, I do think that it’s her,” when discussing the connection between Conrad and the suspended attorney. The District Court said this showed the attorneys had actionable intelligence that she was an imposter. Therefore, Parse waived his rights through the actions (or failed actions) of his attorneys.

Second Circuit Reverses

The Second Circuit vehemently disagreed with the District Court’s holding, and instead held that Parse should have been granted a new trial on the ground that he was deprived of the right to a trial before an impartial jury. The Second Circuit conceded that had the defendant known prior to the end of the trial that a prospective juror had given false voir dire responses and did not reveal the disqualifying falsehoods to the court, “the interest of justice” would not require a new trial under Rule 33. However, the Court referenced a two-part test to help it decide whether the District Court should have granted a motion for a new trial based on juror nondisclosure or misstatements. Citing McDonough Pwr. Equip. v. Greenwood, 464 U.S. 548, 556 (1984), available here, the Court held the party must first show that “a juror failed to answer honestly a material question in voir dire,” and secondly, must show that “a correct response would have provided a valid basis for challenge.” Both prongs were easily met in this case.

The Second Circuit reviewed the District Court’s decision by an abuse of discretion standard, and here it determined the District Court erred as a matter of law by holding Parse waived his rights. The Court wrote that a waiver must be knowing, intelligent, and made with awareness of the likely consequences, which is not what occurred in Parse’s proceedings before the District Court. The Second Circuit also noted that the District Court had no evidence that Parse himself knew about Conrad’s misrepresentations, but regardless the Court believed the District Court erred in ruling that Parse’s attorneys had knowledge in the first place. The Second Circuit stated that not every failure to object or to advance a given argument constitutes a waiver, and especially because Conrad “presented herself as an entirely different person,” any finding that Parse’s attorneys knew prior to trial that she was the same as the suspended attorney was erroneous.

Overall, the Second Circuit acknowledged that Parse’s attorneys could have asked the court to pose additional questions to Conrad, but the Court held that their failure to do so or pursue additional information sufficient to reveal her misrepresentation did not provide an appropriate basis for the District Court’s finding that Parse’s lawyers knew the truth about Conrad and waived Parse’s right to an impartial jury.

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The takeaway from the Second Circuit’s decision is its emphasis on Parse’s constitutional right to an impartial jury trial, and how far the Court believes that right extends. Even though Parse’s attorneys were able to find some information on Conrad and could very well have further inquired as to the discrepancies, they did not, but that did not mean that Parse waived his Sixth Amendment rights. While the Court did not address specifically whether Parse could waive his rights through his attorneys even if he did not have any personal knowledge of Conrad’s lies, this case still implies a high standard for proving waiver. Holding the Government to a preponderance of the evidence standard for proving waiver better values defendants’ constitutional rights.

The attorneys at Fuerst Ittleman David & Joseph have extensive experience in the areas of complex civil and administrative litigation at both the state and federal levels, white collar criminal defense, as well as tax and tax litigation. Should you have any questions or need further assistance, please contact us by email at contact@fidjlaw.com or telephone at 305.350.5690.

Tax Litigation Update: Ninth Circuit Enforces Two-Prong Test to Determine Transferee Tax Liability

June 23rd, 2015

On June 8, 2015, the United States Court of Appeal for the Ninth Circuit reversed the decision of the United States Tax Court after the Tax Court failed to apply the correct legal standard to determine transferee tax liability, which resulted in an improper determination to disregard the form of a transaction. In Slone Revocable Trust v. Cir., available here, the Ninth Circuit presented the correct test to impose tax liability on a transferee. The test, which the Court applied from Comm’r v. Stern, 357 U.S. 39 (1958), available here, requires asking both:

  1. Is the party a “transferee” under 26 U.S.C. § 6901 and federal tax law?
  2. Is the party substantively liable for the transferor’s unpaid taxes under state law?

The Ninth Circuit held that the Tax Court erroneously analyzed both prongs, and therefore remanded the case back to Tax Court for proper determination.

Background

The Slone Revocable Trust case involved two sales related to Slone Broadcasting Co., a radio broadcasting business. In the first sale, Slone Broadcasting Co. sold almost all of its assets to Citadel Broadcasting Co. for $45 million. Slone Broadcasting realized a capital gain of about $38.6 million, which carried with it an income tax liability of $15.3 million. After the sale, no distributions were made to the shareholders. Slone Broadcasting made its first federal income tax payment three months after the sale for $3.1 million.

Before the transaction closed, Fortrend International, LLC proposed a merger deal with Slone wherein Fortrend would purchase all of Slone Broadcasting’s shares for $29.8 million. Fortrend then offered to restructure Slone to engage in the asset recovery business. Slone Broadcasting’s tax attorney green-lighted the deal, but the shareholders continued to ask for information regarding the methods Fortrend would use to reduce the shareholders’ tax liability. Fortrend only said the methods were “proprietary” and assured Slone that the transaction would not be “listed” pursuant to IRS Notice 2001-51, 2001-2 C.B. 190. Slone Broadcasting’s shareholders sold their shares to another company, Berlinetta Inc. (later known as Arizona Media) for $33 million. Several years later Arizona Media was administratively dissolved for failure to file an annual report.

The IRS ultimately sent notices of liability to the former shareholders of Slone Broadcasting for a tax deficiency in the amount of $13.5 million, along with a penalty of $2.7 million and interest of $7.3 million. The notice said the shareholders were liable as “transferees” of the assets. The IRS aimed to disregard the form of the shareholders’ sale of stock to Berlinetta, but the Tax Court concluded that the form of the stock sale should be respected, rejecting the IRS’s theory.

Properly Applying Stern

The Commissioner of the IRS can assess tax liability against a taxpayer who is the transferee of assets of a taxpayer who owes income tax under 26 U.S.C. § 6901. The Court noted that while federal law addresses the procedure for collecting tax liabilities from a transferee, state law determines whether that transferee is substantively liable. This is where the Ninth Circuit brought in the Stern test, which is a two-prong inquiry the Court uses to determine transferee tax liability

In the first prong, which asks whether the party is a transferee under federal law, a transferee can be a “done, heir, legatee, devisee, or distributee,” but can also be a “shareholder of a dissolved corporation” under 26 C.F.R. § 301.6901-1(b). As for the second prong, the Stern test asks about substantive liability, and while it depends on the law of the state where the transfer occurred, the test typically requires showing that the transferee had “actual or constructive knowledge of the entire scheme that renders its exchange with the debtor fraudulent.”

If the form of stock sale transaction between the shareholders and Berlinetta is respected, the shareholders did not receive a liquidating distribution and therefore are not transferees of the assets. Thus, the question was whether the Tax Court erred in respecting the form. The Commissioner argued that the Tax Court erred in analyzing the first prong of the Stern test, and the Ninth Circuit agreed.

The Ninth Circuit held that case law requires courts to consider both subjective and objective factors in characterizing a transaction for tax purposes. This test turns on whether the taxpayer has shown a business purpose other than tax avoidance, and whether the transaction had economic substance beyond the creation of tax benefits. The Court related this idea to the “economic substance doctrine,” and the “substance-over-form doctrine” as part of similar common law which looks at the transaction’s business purpose and economic reality. If an analysis of these factors leads to the conclusion that the transaction has no non-tax business purpose or economic substance, then the form of the transaction should be disregarded.

With all of this in mind, what was the Tax Court’s mistake, exactly? The Ninth Circuit found that the court did not address either subjective or objective factors in characterizing the transaction, as it did not determine any business purpose or economic substance. The Ninth Circuit held that the Tax Court mainly focused on evidence of the shareholders’ lack of actual or constructive knowledge of the tax evasion scheme. It only used this evidence to conclude the form of the sale should be respected under the first prong of the Stern test, but did not use it to analyze shareholders’ liability under the state law in the second prong.

The Commissioner argued that the Tax Court should have found the transaction to be liquidating in substance, just a “shell with nothing but cash and significant tax liabilities.” The Slone Broadcasting shareholders disagreed, arguing that they had potential to acquire another radio station and no improper motivations for the sale. The shareholders also pointed to Fortrend’s debt recovery proposal as evidence of economic substance. The Ninth Circuit felt it could not resolve the dispute because the Tax Court failed to apply the proper test in the first place.

Remand

The Ninth Circuit instructed the Tax Court to apply relevant subjective and objective factors to determine whether the Commissioner erred in disregarding the form of the transaction in order to impose tax liability on shareholders as “transferees” in the first prong, and instructed the court to analyze whether the shareholders were substantively liable under state law in the second prong.

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The takeaway from the Ninth Circuit’s decision is that the Courts of Appeal will require the Tax Court, and the taxpayers litigating in the Tax Court, to apply the proper test and introduce into the record sufficient evidence to justify and support a taxpayer’s claim that he/she should not be subject to transferee liability.  While not a total win for the IRS, neither is it a total loss for the taxpayer. Both parties are now left to, again, try the case before the Tax Court, which must determine whether the taxpayer is subject to transferee liability.

The attorneys at Fuerst Ittleman David & Joseph, PL have extensive experience in the areas of tax and tax litigation.  They will continue to monitor developments in this area of the law. If you have any questions, an attorney can be reached by emailing us at contact@fidjlaw.com or by calling 305.350.5690.

Marijuana Regulatory Update: FDA Concludes CBD Products Are Not Dietary Supplements

June 17th, 2015

In its recently published “FDA and Marijuana: Questions and Answers,” the U.S. Food and Drug Administration (FDA) announced that products containing cannabidiol (CBD), a non-narcotic component of Cannabis sativa, cannot be marketed as dietary supplements because CBD is the subject of an FDA regulated clinical investigation. FDA’s conclusion could be problematic for the growing number of companies marketing and distributing cannabis-based products in states that have legalized marijuana. If these companies continue to market products containing CBD as dietary supplements, FDA could launch enforcement actions against them based upon the allegation that they are selling unapproved new drugs.

How is CBD regulated?

The entire Cannabis plant is listed as a Schedule 1 substance by the Drug Enforcement Administration’s Office of Diversion Control, making trade of any component of the plant illegal in nearly all circumstances under federal law. However, twenty-three states and the District of Columbia have passed laws allowing the use of medical marijuana within their borders. Additionally, voters in four states—Alaska, Colorado, Oregon, and Washington—and the District of Columbia have passed initiatives allowing recreational use of marijuana within their borders. These laws have created a market for an entirely new industry of products containing cannabis-derived substances including foods and dietary supplements. Although FDA has remained largely silent on how products containing cannabis-derived substances are regulated under federal law, it has recently published its policy that products containing CBD cannot be marketed as dietary supplements.

What is a dietary supplement?

Dietary supplements are defined and regulated pursuant to the federal Food, Drug, and Cosmetic Act (FDCA) (21 USC § 321(ff)) as a type of food product intended to supplement the diet that contains one or more dietary ingredients. Dietary ingredients include vitamins, minerals, herbs, botanicals, amino acids, concentrates, metabolites, constituents, and extracts.

To be lawfully marketed as a dietary supplement under the FDCA, a product must essentially meet four criteria: the product must (1) be intended to be ingested orally, (2) not be represented for use a conventional food or sole item of a meal or diet, (3) be labeled as a dietary supplement, and (4) contain one or more compliant dietary ingredients.

The FDCA, along with its related regulations, dictate what constitutes a compliant dietary ingredient that can lawfully be included in the formula of a dietary supplement. We will focus here on one such provision of the FDCA, 21 USC § 321(ff)(3)(B)(ii).

21 USC § 321(ff)(3)(B)(ii)

Many vitamins, minerals, herb, botanicals, and other similar articles are permissible dietary ingredients under the FDCA. However, the FDCA prohibits the use in dietary supplements of certain articles that are the subject of research for pharmaceutical uses. Specifically, the FDCA states that dietary supplements cannot contain:

an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter. (21 USC § 321(ff)(3)(B)(ii).)

This provision prohibits articles studied under an investigational new drug application (IND) from use in dietary supplements if those articles were not marketed as part of a dietary supplement or food prior to the start of the study or research. In order to bring a new pharmaceutical to market in the United States, the sponsor of the pharmaceutical product must go through FDA’s IND process. Once a sponsor’s IND is approved by FDA, the sponsor can begin clinical trials into the safety and efficacy of that drug product for human beings for a specific intended use. Most approved INDs are publically available on www.ClinicalTrials.gov.

The Pyridoxamine Example

Applying this FDCA prohibition, in 2009, FDA responded to a citizen petition filed on behalf of a pharmaceutical company studying the effects of pyridoxamine, a type of vitamin B6, for diabetic nephropathy. (Read FDA’s 2009 response here.) FDA determined that products containing pyridoxamine could not be dietary supplements lawfully marketed within the FDCA because pyridoxamine was authorized for investigation as a new drug pursuant to a publically announced clinical trial. The FDA concluded that no independent, verifiable evidence existed showing pyridoxamine had been marketed as a food or dietary supplement prior to implementation of the clinical investigation into the article. Consequently, companies marketing pyridoxamine supplements could no longer lawfully do so. These companies were forced to remove those products from the market or risk enforcement action by FDA.

In FDA’s response to the citizen petition, the agency further clarified the types of articles included under 21 USC § 321(ff)(3)(B)(ii). FDA determined that an “article authorized for investigation as a new drug” includes both the active ingredient, like pyridoxamine hydrocholoride, as well as the active moiety, like pyridoxamine. (See FDA’s definition of ‘active moiety’ here.) FDA used its conclusion in this pyridoxamine case as an example in its 2011 guidance document, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” which can be read in full by clicking here, stating:

[A]ssume that Substance A, which is a constituent of a plant and has never been marketed as an article of food or as a dietary supplement, is a botanical dietary ingredient under section 201(ff)(1)(C) of the FD&C Act. A drug company is studying a salt of Substance A, “Substance A hydrochloride,” as an investigational new drug under an IND. In this situation, the relevant article for purposes of whether Substance A can be used in a dietary supplement is not Substance A hydrochloride, but Substance A itself, because Substance A is the active moiety that is being studied for its possible therapeutic action. Any compound that delivers Substance A is excluded from being used in a dietary supplement.

FDA’s determination with regard to pyridoxamine expands the number and types of articles that cannot be included as compliant dietary ingredients in dietary supplement formulations.

Why did FDA conclude products containing CBD are not dietary supplements?

FDA’s recently released Q&A page states:

Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.

It is likely that FDA reached this conclusion because GW Pharmaceuticals began a clinical trial in 2013 under an FDA-approved IND to study a pure, synthetic form of CBD for the treatment of childhood epilepsy. FDA has concluded that without evidence of prior marketing of CBD as part of a supplement or food product, GW Pharmaceuticals’ IND application prohibits any manufacturer from marketing a dietary supplement with CBD as an ingredient. However, FDA does indicate that it will consider any evidence submitted to demonstrate that prior to the IND filing, the ingredient was marketed as part of a supplement or food product. FDA’s recent announcement states “[i]nterested parties may present the agency with any evidence that they think has bearing on this issue.”

What does this mean for dietary supplements containing CBD?

Uncertainty surrounds the future of dietary supplements containing CBD. FDA’s current policy is clear in that products containing CBD cannot be marketed as dietary supplements. However, that policy could change should an entity or individual submit evidence to FDA that CBD has been marketed as part of a food or dietary supplement prior to the start of GW Pharmaceutical’s clinical trial in 2013.

Alternatively, if a dietary supplement manufacturer were to demonstrate that the CBD that is the subject of GW Pharmaceutical’s clinical trial is somehow different from the CBD that is utilized in the marketed supplements, the prohibition of 21 USC § 321(ff)(3)(B)(ii) may not apply. (Other new dietary ingredient regulations and policies would likely then apply but that will be the subject of a future post.) Given FDA’s determination in the pyridoxamine this case would be very difficult position to take as the agency’s current policy would exclude any compound that delivers CBD, including CBD and any derivatives of CBD.

Will FDA use the CBD determination as a basis for enforcement actions?

In the agency’s “FDA and Marijuana: Questions and Answers,” the following question and answer are offered:

  1. Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements?
  1. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

Without providing a clear answer to the question, FDA has indicated that it is preserving its authority to take enforcement action against companies that market dietary supplements containing CBD.

In February of 2015, FDA issued warning letters to six companies marketing products claiming to contain CBD (interestingly, FDA notes that some of these were products were tested and shown to not actually contain CBD). However, the violations cited in these letters related primarily to the claims made about the products and the intended uses these companies ascribed to the various CBD products. These warning letters did not cite 21 USC § 321(ff)(3)(B)(ii) as a reason for issuance of the letters.

An FDA warning letter is “issued only for violations of regulatory significance,” which are “violations that may lead to enforcement action” if not corrected swiftly. (FDA Regulatory Procedures Manual 4-1.) Recipients of warning letters are typically granted 10-15 days to correct violations and respond to FDA. Failure to correct such violations or respond to the agency could result in more sever enforcement actions, like injunctions, seizures, and other penalties.

FDA has not yet utilized enforcement mechanisms applying this policy prohibiting CBD in dietary supplements based on 21 USC § 321(ff)(3)(B)(ii). Further, the agency has yet to determine if it will utilize enforcement mechanisms as the market for different products containing marijuana and marijuana derivatives continues to expand. If adverse events stemming from these types of products are reported directly to FDA or through state health agencies, FDA could take action against companies distributing and manufacturing these products. Likewise, if companies or institutions engaged in clinical investigations engage in market discipline, petitioning FDA to actively prohibit the use of CBD in supplements pursuant to  21 USC § 321(ff)(3)(B)(ii), the manufacture and distribution of these types of products will be negatively affected, like the case pyridoxamine in 2009.

Companies in the growing marijuana products industry will need to stay abreast of these federal regulatory issues and aware of possible enforcement actions to prepare for and, hopefully, avoid adverse consequences.  For more information regarding how the FDA regulates the use of CBD in dietary supplements and other products, please contact us at contact@fidjlaw.com.

Complex Litigation Update: Ninth Circuit Holds Magistrate Judges Powerless to Order Remand

June 12th, 2015

A magistrate judge can no longer have the last word when it comes to a motion to remand a case back to state court. On June 8, 2015, the Ninth Circuit Court of Appeals issued its opinion in Flam v. Flam, holding that 28 U.S.C. § 636 does not give a magistrate judge the power to issue a remand order under 28 U.S.C § 1447(c). Instead, a magistrate judge can only issue a recommendation or report for the federal district court judge, who should make the final order. The Ninth Circuit also held that a district court judge is not barred from reviewing a magistrate’s remand order under 28 U.S.C. § 1447(d) because the magistrate lacked authority to make that final decision in the first place.

Background

This case began with a dispute related to the division of pension assets after a divorce. While Laura Flam originally filed suit in Fresno County Superior Court in June 2012, Dr. Marshall Flam timely removed the case to the Eastern District of California based on federal question jurisdiction. He claimed the suit was governed by the Employee Retirement Security Act. Ms. Flam moved to remand the case to state court, and the magistrate judge issued an order to remand. Dr. Flam filed a motion for reconsideration of the removal order, but the district court refused to grant the motion for reconsideration.

In refusing to grant the motion for reconsideration, the district court determined it could not reconsider due to 28 U.S.C § 1447(d), which states in part “[a]n order remanding a case to the State court from which it was removed is not reviewable on appeal or otherwise.” Dr. Flam appealed this denial. On appeal, the Ninth Circuit addressed the issues of “whether a magistrate judge is empowered to issue an order remanding a removed case to state court, and whether such an order, once made, may be reviewed by the district court.”

The Magistrate Court’s Lack of Power to Order Remand

On appeal, the Ninth Circuit held that magistrate judges lack the power to issue remand orders primarily because the court defines such remand motions as “dispositive.” As explained by the Ninth Circuit, the Federal Magistrates Act, 28 U.S.C. § § 631-39 provides that “certain matters (for example, non-dispositive pretrial matters) may be referred to a magistrate judge for decision, while certain other matters (such as case-dispositive motions…) may be referred only for evidentiary hearing, proposed findings and recommendations.”

While the Federal Magistrates Act lists several dispositive matters, see 28 U.S.C. § 636(b)(1)(A), the Ninth Circuit found that the list is not exhaustive. In determining whether a motion not listed in 28 U.S.C. § 636(b)(1)(A) is dispositive, the Ninth Circuit uses a functional approach based on the effect of the motion.

In its analysis, the Ninth Circuit started with the Supreme Court’s view that judicial functions could be dispositive notwithstanding their absence from § 636(b)(1)(A). More on point, the Ninth Circuit addressed its “sister circuit” decisions, where other federal courts of appeal have specifically considered whether a remand motion is dispositive. The Second, Third, Sixth and Tenth Circuits all analyzed the issue of a magistrate’s authority regarding remand by analyzing the practical effect of the challenged action on the litigation.

Similar to its sister courts that ruled on the same issue, the Ninth Circuit here held that a motion to remand is a dispositive one. It pointed to In re U.S. Healthcare, a Third Circuit case, which held that a remand order “preclusively determines the important point that there will not be a federal forum available to entertain a particular dispute.” Like its sister circuits, the Ninth Circuit ruled that the magistrate’s decision was dispositive and therefore beyond the magistrate’s jurisdiction.

The District Court’s Ability to Review the Magistrate’s Decision

The second issue that the Ninth Circuit considered was whether 28 U.S.C. § 1447(d) bars review of the magistrate judge’s order. In short, the court found that the statute permits the district court judge to review.

Although, 28 U.S.C. § 1447(d) says “an order remanding a case to the State court from which it was removed is not reviewable on appeal or otherwise…,” the court recognized exceptions to this rule, and interpreted prior cases to mean that if a court lacked authority to remand under §1447(c), § 1447(d) would   not preclude review because the two must be construed together. Thus, if the magistrate judge lacked authority to issue an order to remand in the first place, § 1447(d) does not apply. The Second, Third, and Sixth Circuits have concluded that § 1447(d) does not bar review of a magistrate judge’s order, and the Ninth Circuit agreed.

As a result of the Ninth Circuit’s decision, the district court is left with two options in addressing the remand issue: 1) the district court could address the merits of the motion in the first instance; or 2) the district court could allow the magistrate to address the merits of the remand motion through a report and recommendation similar to other dispositive motions which routinely come before magistrates such as motions for summary judgment and motions to dismiss. If the latter option is chosen, then the parties have an opportunity to object to the magistrate’s findings in its report and recommendation by filing such objections with the district court. In instances where objections are filed, the findings of the magistrate will be reviewed de novo by the district court.

The attorneys at Fuerst Ittleman David & Joseph have extensive experience in the areas of complex civil and administrative litigation at both the state and federal levels. Should you have any questions or need further assistance, please contact us by email at contact@fidjlaw.com or telephone at 305.350.5690.

Hastert Indictment: How the Bank Secrecy Act Can Criminalize Otherwise Lawful Activity

June 9th, 2015

On May 28, 2015, former Speaker of the United States House of Representatives Dennis Hastert was indicted and charged with one count of making false statements to a federal law enforcement officer in violation of 18 U.S.C. § 1001(a)(2), and one count of structuring to evade currency reporting requirements in violation of 31 U.S.C. § 5324. Both charges relate to a series of cash withdrawals Hastert made in order to complete a series of payments to on unidentified person who had accused Hastert of sexually assaulting him more than 30 years earlier. As explained by Jeffrey Toobin in his article for The New Yorker, the case against Hastert is a prime example of how conduct which itself may not be criminal in nature can become criminal through the failure to comply with the Bank Secrecy Act. A copy of the indictment can be read on the Chicago Tribune’s website here.

Generally speaking, the Bank Secrecy Act (“BSA”), 31 U.S.C. 5311-5330, and its implementing regulations, found at 31 C.F.R. Chapter X, require financial institutions to keep records of certain financial transactions and report these transactions to the federal government. The BSA was designed to prevent financial institutions from being used as part of illicit activity such as money laundering, drug trafficking, tax evasion, and terrorist financing.

In particular, 31 U.S.C. § 5313 (a) requires domestic financial institutions, including banks, which are involved in a transaction for the payment, receipt, or transfer of United States currency in an amount greater than $10,000.00, to file a currency transaction report (“CTR”) for each cash transaction with the IRS. Additionally, pursuant to31 C.F.R. § 1010.313(b) “multiple currency transactions shall be treated as a single transaction if the financial institution has knowledge that they are by or on behalf of any person and result in either cash in or cash out totaling more than $10,000 during any one business day.”

Occasionally, depositors will “structure” their transactions so that multiple cash deposits are made each under $10,000, sometimes over the course of several days or at multiple braches of a bank, in an effort to avoid the reporting requirements of the BSA. Such activity is known as “structuring” and is prohibited by federal law. 31 U.S.C. § 5324 makes it a crime for an individual to: a) “cause or attempt to cause a domestic financial institution to fail to file a report under § 5313(a);” b) “cause or attempt to cause a domestic financial institution to file a report required under § 5313(a) that contains a material omission or misstatement of fact;” or c) “structure or assist in structuring, any transaction with one or more domestic financial institutions” for the purpose of evading the reporting requirements of § 5313(a). More information on the BSA can be found on FinCENs website.

In Hastert’s case, paying money to an alleged victim of previous conduct which is most likely non-prosecutable because of a running of the statute of limitations is not criminal in and of itself. As the Toobin article notes, had Hastert simply paid the alleged victim by check, no violation of law would have occurred. Here however, once Hastert made the decision to make cash payments, he was under an obligation to comply with the reporting requirements of the Bank Secrecy Act. As alleged in the indictment, once Hastert realized CTRs were required to be filed for his withdrawals over ten thousand dollars, Hastert proceeded to structure his withdrawals such that he would make several smaller transactions under the ten thousand dollar reporting requirement in an effort to avoid reporting. As a result, Hastert transformed legal conduct into illegal conduct and faces criminal prosecution.

The Hastert case is a prime example of how even perfectly legal financial transactions can lead to criminal liability when they are executed with the aim of evading or circumventing the BSA As another example, as we previously reported, despite the wishes of clients, attorneys are under an obligation to maintain their trust accounts in compliance with the BSA. Thus, attorneys cannot structure trust account deposits and withdrawals in an effort to shield client identity.

Another example may be found in the burgeoning marijuana industry. There, despite changing state legislation, the federal government still lists marijuana as a Schedule I controlled substance under the Controlled Substances Act (“CSA”) 21 U.S.C. § 801 et seq, and the possession, use, and distribution of marijuana remains criminal under federal law. With regards to banking for marijuana related businesses and the BSA, FinCEN has explained:

Because federal law prohibits the distribution and sale of marijuana, financial transactions involving a marijuana-related business would generally involve funds derived from illegal activity. Therefore, a financial institution is required to file a SAR on activity involving a marijuana-related business (including those duly licensed under state law), in accordance with this guidance and FinCEN’s suspicious activity reporting requirements and related thresholds.

(emphasis added). See FinCEN, FIN-2014-G001, BSA Expectations Regarding Marijuana-Related Businesses, (February 14, 2014), available here. Thus, because the sale of marijuana remains prohibited under federal law, financial institutions are placed in a position where, if they agree to service marijuana dispensaries, they would be required to report any transaction regardless of State law. (More information on marijuana related BSA requirements can be found in our previous report here.).

As a result of these reporting requirements, many legal marijuana businesses have resorted to all cash operations. With the rigorous reporting requirements in place, dispensaries are looking for “creative” ways to engage in banking including: 1) establishing shell companies to disguise marijuana proceeds; 2) funneling marijuana derived profits into accounts of other legitimate businesses; and 3) placing marijuana derived profits into bank accounts of family members or personal accounts. However, generally speaking, the use of shell companies or other accounts to mask the profits derived from the sale of marijuana could subject the owner of a dispensary to a wide variety of federal criminal penalties, including bank fraud 18 U.S.C. § 1344, wire fraud 18 U.S.C. § 1343, and money laundering 18 U.S.C. § 1956. (More information on marijuana-related business banking difficulties can be read here.).

The attorneys at Fuerst Ittleman David & Joseph, PL have extensive experience in the areas of administrative law, anti-money laundering, tax law and litigation, constitutional law, white collar criminal defense and litigating against the U.S. Department of Justice. If you are a financial institution or if you seek further information regarding the steps which your business must take to remain compliant, you can reach an attorney by emailing us at contact@fidjlaw.com or by calling us at 305.350.5690

Eleventh Circuit Reverses District Court’s Collateral Estoppel Ruling, Giving A Dietary Supplement Company Another Chance To Substantiate Advertisements.

June 3rd, 2015

The dietary supplement industry is regulated by the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”). The FTC has regulatory authority over the advertising of dietary supplements, while the FDA has regulatory authority over the labeling and manufacturing. (To see the full FTC regulatory scheme for dietary supplements please click here.)

Generally speaking, when a dietary supplement company advertises a product, the company must show some form of “competent and reliable scientific evidence” to substantiate its claims. The definition of “competent and reliable scientific evidence” has become a $40 million issue for Hi-Tech Pharmaceuticals. Although the industry standard allows “competent and reliable scientific evidence” to be flexible, the FTC does not rely upon “industry standards.” Instead, the FTC has stated through guidances and case law that “competent and reliable scientific evidence” means “tests, analyses, research, studies, or other evidence.” More recently, the agency has narrowed its interpretation of “competent and reliable scientific evidence” through consent decrees (settlement with private parties that are not developed via the Administrative Procedure Act’s (“APA”) notice-and-comment rulemaking process), to redefine “competent and reliable scientific evidence” to exclusively be defined as two randomized, double blind, placebo controlled clinical trials (“RCTs”). (For an example of how the FTC has done this in practice, please click here. To read what we have previously reported on this issue, please click here.)

On May 5, 2015, the Eleventh Circuit reversed a $40 million judgement against Hi-Tech Pharmaceuticals and related defendants entered by the United States District Court for the Northern District of Georgia. In the Eleventh Circuit’s decision, it ruled that the “district court misapplied the doctrine of collateral estoppel when it barred Hi-Tech Pharmaceuticals . . . from presenting [non-RCT] evidence to prove their compliance with the injunctions against them.”(Read the entire opinion here.) See FTC at 2-3. The district court found Hi-Tech “in contempt for violating [the] injunctions that prohibit them from making any representation about weight-loss products unless they ‘possess[ ] and rely[y] upon competent and reliable scientific evidence that substantiates the representation,’” and thereby collaterally estopped Hi-Tech from presenting evidence to substantiate its claims. Id. at 2. But, on appeal, the Eleventh Circuit ruled that the district court erred when it misapplied the law by not allowing Hi-Tech’s evidence to be presented.

Background

Litigation between the FTC and Hi-Tech commenced in 2004, when the FTC filed a complaint against Hi-Tech and related defendants for violations of section 5 and 12 of the Federal Trade Commission Act. See FTC at 3. The FTC claimed that the defendants “made unsubstantiated representations about two weight-loss products (Thermalean and Lipodrene).” Id. In 2008, the district court granted summary judgement in favor of the FTC, concluding that the defendants had violated the FTC Act “because they had not substantiated their representations with clinical trials of the weight-loss products instead of ingredients in the products.” Id. This resulted in a permanent injunction against the defendants which “prohibited [them] from making any representation that [Thermalean and Lipodrene] ‘causes rapid or substantial loss of weight or fat’ or ‘affects human metabolism, appetite, or body fat,’ unless the defendants ‘possess and rel[y] upon competent and reliable scientific evidence that substantiates the representation.’” Id. at 4-5. The injunction did not mention any requirement for RCTs.

After the 2004 case concluded, the defendants did not stop promoting weight-loss products, and began advertising new dietary supplements: Fastin, Stimerex-ES, Benzedrine, and the newly formulated Lipodrene.  In 2011 “the Commission moved the district court to order Hi-Tech, Wheat, and Smith to show cause why they should not be held in contempt for making unsubstantiated representations” about these four products. Id. at 5. In response, the defendants submitted evidence (100 peer-reviewed and double blind studies of the ingredients within the supplements) to support their representation. Nevertheless, the district court held that “because the defendants had not produced clinical trials on the four products at issue in the contempt proceedings” Hi-Tech and related defendants were “jointly and severally liable for approximately $40 million in sanctions.” Id. at 9.

Eleventh Circuit Decision

Hi-Tech appealed the judgement of the district court to the United States Court of Appeals for the Eleventh Circuit. On appeal, the Eleventh Circuit ruled that the district court abused its discretion when it held the defendants in contempt “and misapplied the doctrine of collateral estoppel when it refused to consider the defendants’ evidence of substantiation.” Id. at 10. Because the district court erred in adopting a stricter standard for substantiation (regarding the advertising claims of the four dietary supplements), the Eleventh Circuit held the district court’s holding must be vacated and remanded. However, in deciding this case, the Court clarified two principles: (1) when the doctrine of collateral estoppel is applied, and (2) the standard used when ruling on injunctions.

The doctrine of collateral estoppel, which protects defendants from being tried for the same issue in more than one trial, is applied only when the following four criteria are met: (1) the current issue is identical to the prior; (2) the identical issue was litigated in the prior suit; (3) the determination of the issue was a critical and necessary part of the judgment; (4) there is full and fair opportunity to litigate the issue. (You can find the full discussion of the four criteria of collateral estoppel here.) According to the Eleventh Circuit, the first criteria was not met in the FTC’s case against Hi-Tech, and therefore the doctrine was erroneously applied. Hi-Tech could “easily” show that the current issue (the 2011 litigation) was not identical to the prior (the 2004 litigation). As the Eleventh Circuit stated, “the issue decided in the earlier litigation involved different representations, different products, and the interpretation of a different legal standard from the issue the district court prevented Hi-Tech from litigating in the contempt proceedings.”Id. at 11. Therefore, Hi-Tech should not have been collaterally estopped from putting on its chosen defense in the contempt proceedings.

The defendants also argued that the district court erred by adopting an impermissibly strict standard for substantiation. However, the Eleventh Circuit did not rule on this issue. Rather, it clarified for the purposes of remand, “the district court must exercise its discretion to determine the admissibility of any evidence offered by the Commission and by the contempt defendants and make findings about whether any evidence of substantiation, if admissible, satisfies the standard of the injunctions for ‘competent and reliable scientific evidence.’” Id. at 13.

The Uncertain Future of What “Competent and Reliable Scientific Evidence” Means

The Eleventh Circuit’s ruling is another blow to the FTC seeking to enforce an RCT standard that was not promulgated through the statutorily required notice-and-commenting rulemaking process. Upon remand to the district court, Hi-Tech should be permitted to rely upon the evidence it initially brought—evidence that is less rigorous than RCTs—to substantiate its advertising claims. It will then be up to the district court to decide whether reliance upon evidence less stringent than two RTCs is consistent with the injunction entered in 2008. Regardless of how the district court rules, the table will likely be set for another Eleventh Circuit decision, wherein the court may be forced to evaluate the lawfulness of FTC’s position regarding RCTs.

Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of dietary supplement labeling and advertising. The attorneys in our Food, Drug, and Life Sciences practice group are experienced in assisting regulated industry to ensure that products are marketed and advertised in compliance with all applicable federal laws and regulations. For more information, please call us at (305) 350-5690 or email us at contact@fidjlaw.com.

Florida Commercial Litigation Update: Cross-Border Contracts and Forum Selection Clauses

May 28th, 2015

Florida’s Third District Court of Appeal, in Michaluk v. Credorax (USA) Inc., Case No. 3D14-985, 40 Fla. L. Weekly D1133a (Fla. 3d DCA May 13, 2015), available here, recently underscored the importance of careful contract drafting in commercial transactions, especially those involving cross-border issues.

For example, individuals and businesses who conduct their affairs across multiple jurisdictions often use forum selection clauses to establish by contract how a dispute or claim resulting from the contract will be resolved, including whether the dispute will be subject to a specific body of law or process of resolution, and/or will be initiated in a specific jurisdiction or venue.  Thus, these clauses typically identify which law will govern a dispute or interpretation of the contract (e.g., the laws of Malta), where the dispute will be brought (e.g., Broward County, Florida) and/or which dispute resolution process will govern any dispute (e.g., litigation in state and federal courts, as opposed to arbitration, mediation or any other process).

The court in Michaluk addressed the interpretation of a written forum selection clause as being either mandatory or permissive with respect to venue.  Specifically, the contract at issue in that case—an “Introducer Agreement” between, on the one hand, a foreign (Maltese) bank and processor of credit or debit card payments for online sellers and, on the other hand, a foreign (Canadian) consultant—provided for payment to the consultant of a transaction fee for the solicitation of new business and bank clients.  Under the clause, titled “Governing Law and Jurisdiction,” the contracting parties agreed as follows:

This Agreement shall be governed by and construed in accordance with the Laws of Malta and each party hereby submits to the jurisdiction of the Courts of Malta as regards any claim, dispute or matter arising out of or in connection with this Agreement, its implementation and effect.

After a dispute over the payment of certain transaction fees, Michaluk (the consultant) filed a complaint in Florida state court against the foreign bank (Credorax Malta) and its U.S. affiliate (Credorax USA) alleging claims for fraud in the inducement, unfair and deceptive trade practices, unjust enrichment, and breach of contract.  The defendants moved to dismiss the lawsuit for, among other reasons, improper venue, arguing that the parties’ contract contained a mandatoryforum selection clause designating the venue for any dispute under the contract to Malta alone.  The plaintiff responded that the clause was merely permissive, such that the contract did not prohibit the filing of a lawsuit in a different jurisdiction (other than Malta).

The trial court ruled that the language in the forum selection clause was mandatory; however, on appeal, the appellate court ruled the other way, finding the language at issue to be permissive and not mandatory.

Preliminarily, the Third District reaffirmed the line of cases holding that forum selection clauses should be enforced in the absence of a showing that enforcement would be unreasonable or unjust, noting that forum selection clauses are now “routinely enforced” given present-day commercial realities and expanding international trade.

The court in Michaluk then clarified the material difference between mandatory and permission forum selection clauses, stating that a forum selection clause will be deemed mandatory where, by its express terms, suit may be filed only in the forum named in the clause, whereas a permissiveclause is essentially a “consent” to specific jurisdiction or venue in the named forum and does not exclude jurisdiction or venue in any other jurisdiction.  The critical inquiry is whether the plain language used by the contracting parties indicates “exclusivity.”  Therefore, a forum selection clause will be deemed permissive absent words of exclusivity.  Federal and state case law reflects the varying—and sometimes seemingly inconsistent—interpretations of the exclusivity of a forum selection clause.

Michaluk, citing the decisions of other courts interpreting forum selection clauses employing similar language to the language used in the “Introducer Agreement” quoted above, highlights the judiciary’s wordsmithery in this context.  For example, as noted in Michaluk, the following forum selection clauses were found to be mandatory:

This Agreement and the rights and obligations of the parties shall be governed by and construed in accordance with the laws of the State of Florida. The parties hereto consent to Broward County, Florida as the proper venue for all actions that may be brought pursuant hereto.  [See Golf Scoring Sys. Unlimited, Inc. v. Remedio, 877 So. 2d 827 (Fla. 4th DCA 2004).]

Any controversy relating to this agreement or any modification or extension of it and any proceeding relating thereto shall be held in Minneapolis, Minnesota. The parties hereby submit to jurisdiction for any enforcement of this agreement in Minnesota.  [See Sonus-USA v. Thomas W. Lyons, Inc., 966 So. 2d 992 (Fla. 5th DCA 2007).]

In contrast, the following similar clauses, which likewise employ the terms “shall be” to denote words of exclusivity, were found to be permissive:

Any litigation concerning this contract shall be governed by the law of the State of Florida, with proper venue in Palm Beach County.  [See Regal Kitchens, Inc. v. O’Connor & Taylor Condo. Constr., Inc., 894 So. 2d 288 (Fla. 3d DCA 2005).]

This instrument shall be construed in accordance with the laws of Massachusetts. The Guarantor hereby consents to the jurisdiction of the state and federal courts of the Commonwealth of Massachusetts.  [See Shoppes Ltd. P’ship v. Conn, 829 So. 2d 356 (Fla. 5th DCA 2002).]

Ultimately in Michaluk, the Third District found the forum selection language used in the “Introducer Agreement” (quoted above) to be permissive, concluding that use of the word “submitsto the jurisdiction,” instead of “consents to the jurisdiction,” failed to provide the requisite exclusivity to render the clause mandatory.

Michaluk is unique, because, among other reasons, the parties in that case stipulated that the language of the forum selection clause was unambiguous; and, further, the trial court did not hold an evidentiary hearing that might have provided a factual basis to resolve any purported claim of ambiguity or other material factor related to contract construction, such as parol evidence of the parties’ intent when they drafted the contract or the threshold issue of which party drafted the clause at issue (as, in many jurisdictions, including Florida, contracts may be construed against the drafter if other rules of construction do not apply).  The court in Michaluk also cautioned that the diverse language in forum selection clauses often prevents “direct application of or reliance on” prior court decisions.

At bottom, the Michaluk decision underscores the importance of careful contract drafting up-front, before costly and unpredictable litigation ensues, especially in cross-border, commercial dealings that implicate diverse forums, laws and dispute resolution processes.  When disputes and/or litigation do arise, the decision also reaffirms the importance of exploring all prosecution (or defense) strategies, including, without limitation, an evidentiary challenge of the underlying construction of the contract—something that apparently was not done in Michaluk and materially impacted the contract interpretation in that case.

The attorneys at Fuerst Ittleman David & Joseph specialize in the complexities of commercialized globalization and have extensive experience in all areas of complex civil and criminal litigation, pre-litigation and arbitration, including international and domestic business disputes, as well as wealth preservation and asset protection (whether domestically or offshore).  Please contact us by email at contact@fidjlaw.com or telephone at 305.350.5690 with any questions regarding this article or any other issues on which we might provide legal assistance.

Complex Litigation Update: Eleventh Circuit Holds Engle-progeny State-law Claims Preempted by Federal Law

May 7th, 2015

On April 8, 2015, the United States Court of Appeals for the Eleventh Circuit issued its opinion inGraham v. R.J. Reynolds Tobacco Co., holding that Engle-progeny based strict-liability and negligence claims, i.e. those claims premised solely on the facts found in the landmark Florida class action case R.J. Reynolds Tobacco Co. v. Engle and its clarifying progeny, are preempted by Federal law. In so holding, however, the Court emphasized that it expressed no opinion as to the validity of other Engle based claims and that injured plaintiffs could still pursue strict-liability and negligence claims so long as they do not rely on the Engle jury findings to do so.

Although limited to the facts of Engle, the decision serves as a primer on the concept of preemption, especially for those who may otherwise not face such issues in their practices. The decision also serves as a guidepost to possible preemption issues which may arise for businesses in industries which are subject to both federal and state regulations. A copy of the opinion can be read here.

  1. The Engle Cases

In order to fully understand the Court’s rationale in Graham, some background information is necessary. The Graham case was born out of the remnants of a 1994 class-action lawsuit in which 700,000 Floridians brought state-law damages claims against multiple tobacco companies for various medical conditions allegedly caused by the plaintiffs’ addiction to cigarettes. R.J. Reynolds Tobacco Co. v. Engle, 672 So. 2d 39 (Fla. 3d DCA 1996). Ultimately, a class-wide trial was held on the issue of liability and the jury rendered a verdict for the class plaintiffs on all counts, including strict liability and negligence claims. After trial on liability, the Florida Supreme Court decertified the class but allowed the former class members to pursue causes of action individually. These new individual cases by former Engle class action plaintiffs are known as “Engle-progeny cases.”

However, when decertifying the class, the Florida Supreme Court held that jury findings would have a “res judicata effect” in future cases brought by decertified class members against the tobacco companies. Among the findings in Engle which could be applied going forward was that the defendant tobacco companies “placed cigarettes on the market that were defective and unreasonably dangerous” and that “all Engle defendants were negligent.”

  1. The Graham Case: A Factual Overview.

The Graham case is an Engle-progeny case. In Graham, Plaintiff, the personal representative of his wife’s estate, brought a wrongful-death action against R.J. Reynolds Tobacco and Phillip Morris USA, Inc. alleging that the decedent was addicted to cigarettes and this addition caused her death. Included in the Plaintiff’s multi-count complaint were claims for strict liability based on the fact that “the cigarettes sold and placed on the market by the defendants were defective and unreasonably dangerous,” and a negligence claim based on the fact that the defendants were negligent “with respect to smoking and health and the manufacture, marketing and sale of their cigarettes.”

At trial, the tobacco companies objected to the use of the Engle findings regarding defective products and negligence. Ultimately, the jury found in favor of the Plaintiff. Following the jury’s verdict, the Defendants filed a renewed motion for judgment as a matter of law claiming that federal law preempted the jury’s finding of tort liability based on the Engle jury findings. The District Court denied the motion and the Defendants appealed.

  • A Primer on Preemption

As explained by the Court in Graham:

Federal law may preempt state law in three ways. First, Congress has the authority to expressly preempt state law by statute. Second, even in the absence of an express preemption provision, the scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it. Third, federal and state law may impermissibly conflict, for example where it is impossible for a private party to comply with both state and federal law, or where the state law at issue stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.

Graham, — F.3d –, 2015 WL 1546522, *11 (11th Cir. April 8, 2015). These broad categories are known as express preemption, field preemption, and conflict/obstacle preemption, respectively.

In Graham, the Court was faced with a conflict preemption issue: whether the legal duties imposed by an adoption of the Engle findings regarding defective products and negligence which underpin the strict-liability and negligence claims stand as an obstacle to the accomplishment of federal objectives in the regulation of, but not the outright banning of, cigarettes.

As explained by the Court in Graham, a party alleging that state law is preempted under the theory of conflict preemption faces “a high threshold” because of the “presumption against preemption – namely, that ‘we start with the assumption that the historic police powers of the States were not to be superseded by [federal law] unless that was the clear and manifest purpose of Congress.’”Graham, 2015 WL 1546522 at 12 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).

When faced with conflict preemption challenges, especially those based on frustration of objective, courts look to congressional intent. As explained in Graham:

In assessing the extent to which state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, what constitutes a sufficient obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and identifying its purpose and intended effects. To begin then we must first ascertain the nature of the federal interest.

2015 WL 1546522 at 12 (internal quotations and citations omitted).

  1. The Court’s Rationale

In ruling that the wholesale adoption of Engle findings to individual plaintiff claims for strict liability and negligence was preempted and therefore barred, the Court first looked to Congress’s intent in tobacco regulation. The Court noted that Congress had passed at least seven statutes regarding the regulation of tobacco in the fifty years since it had evidence that cigarettes adversely effected health. The Court noted that while Congress knew such information and possessed the power to ban tobacco, Congress chose not to. Instead, Congress focused on reforms to labeling, marketing, and advertising in an effort to fully inform users of cigarettes danger and “thereby permit[] free but informed choice.” Id. at 13.

The Court concluded that Congress made such decisions to balance the competing interests of protecting public health while acknowledging the important role tobacco production and manufacturing plays in the national economy. An example of this balance noted by the Court was Congress’s expansion of authority to the FDA to regulate tobacco products, while expressly prohibiting the FDA from banning all cigarettes or requiring the reduction of nicotine yields of a tobacco product to zero. Thus, the Court found “Congress has never intended to prohibit consumers from purchasing cigarettes. To the contrary, it has designed a ‘distinct regulatory scheme’ to govern the product’s advertising, labelling, and – most importantly – sale.” Id. at 14; citing FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 155 (2000).

In turning to how the strict liability and negligence claims in Engle-progeny cases based on theEngle jury’s findings frustrate the congressional objectives, the Court found that the Engle court’s findings imposed a duty on all cigarette manufacturers that was breached every time the manufacturers placed a cigarette on the market.

As explained by the Court:

In sum, brand-specific defects were not determined during Phase I; they do not need to be determined during Engle-progeny trials, either. And the class definition is of no help, because it does not distinguish among plaintiffs who smoked different brands at different times—all addicted smokers are the same; so, too, are all cigarettes. Thus, as a result of the interplay between the Florida Supreme Court’s interpretations of the Engle findings and the strictures of due process, the necessary basis for Graham’s Engle-progeny strict-liability and negligence claims is that all cigarettes sold during the class period were defective as a matter of law. This, in turn, imposed a common-law duty on cigarette manufacturers that they necessarily breached every time they placed a cigarette on the market. Such a duty operates, in essence, as a ban on cigarettes. Accordingly, it conflicts with Congress’s clear purpose and objective of regulating—not banning—cigarettes, thereby leaving to adult consumers the choice whether to smoke cigarettes or to abstain. We therefore hold that Graham’s claims are preempted by federal law.

Graham, 2015 WL 1546522 at 18.

  1. Analysis of Graham

In essence, the Court held that the express absence of prohibition of a product in a heavily regulated area of law is evidence of congressional intent not to prohibit the product and, as such, can serve as the basis for a preemption challenge to state and common law duties which would require a product’s banning. While this logic may seem expansive, it is consistent with the existing tobacco related case law.

In FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), the Supreme Court addressed the issue of whether the FDA had the authority to regulate tobacco products. In determining that Congress had not intended the FDA to regulate tobacco, the Supreme Court looked to both the existing regulatory scheme in cigarette regulation and the statutory mandate of the FDA. Similar to the court in Graham, the Supreme Court concluded that Congress had established a comprehensive regulatory scheme for tobacco products that existed outside of the Food, Drug, and Cosmetic Act. This scheme regulated, rather than prohibited tobacco product use. Id. at 139.

However, the Supreme Court concluded that if tobacco could be properly classified as a product that falls under FDA authority, the agency would have no choice but to ban tobacco as a misbranded product due to the unreasonable health risks associated with its use. Id. at 137. This, the Supreme Court concluded, would go against congressional intent and objectives in regulating the tobacco industry. Id. at 139. Thus, the Supreme Court ultimately concluded that the FDA lacked jurisdiction to regulate tobacco products. (Note, subsequent to this decision, Congress granted the FDA the authority to regulate but not ban cigarette products. See generally 21 U.S.C. § 387g.).

  1. Preemption Quagmires In Other Regulated Industries

The issue of preemption often arises in industries which are regulated at both the state and federal levels or in those areas, where traditional state common law duties may conflict with a robust federal scheme. Of note, these areas include food & drug law and the budding cannabis marketplace.

In the context of food & drug law, the preemption issue has arisen in a series of cases regarding whether state common law duties associated with theories of negligence (similar to those in theGraham case above) can coexist with duties imposed on drug and medical device manufacturers under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Though the results of those cases were mixed, and a comprehensive analysis of each is beyond the scope of this article, the essence of the issue is best capsulated in the dissent of Wyeth v. Levine, 129 S. Ct. 1187 (2009). As painstaking detailed in the dissent, the issue in such cases is whether Congress intended the federal regulatory agency to be the exclusive means of regulation. If so, state common law duties will be preempted. Compare, Wyeth, 129 S. Ct. 1187 (2009)(holding that the FD&C Act did not preempt state common law causes of action for negligence and strict product liability against a brand name drug manufacturer for failure to warn of dangers of its drug products because of Congress’s long standing view that traditionally regarded state law as a complementary form of drug regulation) with Pliva, Inc. v. Mensing, 131 S.Ct 2567 (2011) (holding that because of the unique requirements placed upon generic drug manufacturers under the FD&C Act which prohibit them from unilaterally modifying their labels, state tort law claims were preempted).

Another area where preemption may come into play is the burgeoning cannabis industry. Although twenty-three states and the District of Columbia currently have laws legalizing marijuana in some form, (either medicinal or recreational), marijuana remains a Schedule I controlled substance under the Controlled Substances Act (“CSA”). Thus, under federal law, the use, possession, sale, cultivation and transportation of marijuana in the United States remains illegal. Recently, Colorado’s recreational use laws have become the subject of litigation based on the ideas of express and conflict preemption.

In two separate cases, one brought in the United States District Court for the District of Colorado by a group of Sheriffs from Colorado and neighboring states, and the other brought directly in the Supreme Court by Nebraska and Oklahoma, the plaintiffs have argued that Colorado’s recreational use laws are preempted by federal law. More specifically, in each case the plaintiffs argue that Colorado’s recreational use laws are expressly preempted by the CSA. In addition, the plaintiffs argue that even if the CSA does not expressly preempt Colorado law, Colorado’s recreational use laws stand as an obstacle to the overarching federal regulatory scheme regarding cannabis, which not only includes the CSA but also several international treaties. The courts have yet to decide these cases and it remains to be seen whether preemption arguments become the new arrow in the quiver of the anti-cannabis contingency.

The attorneys at Fuerst Ittleman David & Joseph have extensive experience in the areas of complex civil and administrative litigation at both the state and federal levels. In addition, Fuerst Ittleman David & Joseph provides comprehensive representation to highly regulated businesses, including clients operating in the financial services, biotechnology, and international trade industries, and frequently lectures on these subjects for industry trade groups. The firm has more recently been called upon to combine its Food and Drug and Anti-Money Laundering practice areas in assisting marijuana-related businesses achieve financial compliance. Please contact us by email at contact@fidjlaw.com or telephone at 305.350.5690 with any questions.