CMS Delays Data Collection by Manufacturers under the Physician Payments Sunshine Act Until January 1, 2013

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On May 3, 2012, Marilyn Travenner, Acting Administrator of the Centers for Medicare and Medicaid Services (“CMS”), sent a letter to Senator Charles Grassley (R-IA) formally responding to a letter sent to her on April 4, 2012 by Senator Grassley and Senator Herb Kohl (D-WI) urging CMS to issue its final rule implementing the Physician Payments Sunshine Act (“the Sunshine Act”) (see our previous post here). The CMS letter states, among other things, that drug and medical device manufacturers do not need to begin collecting data required under the Sunshine Act before January 1, 2013.

As we previously reported, the Sunshine Act, section 6002 of the Patient Protection and Affordable Care Act (“PPACA”), requires drug and medical device manufacturers to annually report to CMS payments made to physicians, and also requires that CMS, in turn, provide these required payment disclosure reports to the public through a searchable website. CMS published a proposed rule on December 19, 2011 with a 60-day comment period. As of the close of the comment period on February 17, 2012, CMS had received over 300 comments from a variety of stakeholders.

In their April 4 letter, Senators Grassley and Kohl urged CMS to release a final rule implementing the Sunshine Act by June of 2012 so that drug and device manufacturers could do a partial reporting to CMS for 2012. However, in its response letter, CMS stated that in order for a sufficient amount of data to be collected in 2012, the final rule would have to be issued in early 2012 to allow applicable manufactures an appropriate time period to collect and prepare the data submissions. The letter states,  “[g]iven the volume of the public comments received, and the numerous important issues to be clarified and refined in the final rule, CMS does not believe it is feasible to address all of the remaining issues in such a short time period.” CMS does intend to release a final rule later this year, but it will not require data collection by manufacturers before January 1, 2013.

In CMSs May 3 response to the Senators, Administrator Tavenner states that CMS has identified an internal work group for implementation, which is composed of both technical and policy staff. Currently, the work group is assessing the staffing and resources that will be required for full implementation of the Sunshine Act. The letter also states that CMS plans to issue a request for proposal this year to further aid with implementation.

Fuerst Ittleman will continue to monitor CMSs progress on issuing the final rule implementing the Sunshine Act. For more information, please contact us at contact@fuerstittleman.com or (305) 350-5690.

What Food Manufacturers Should Know about “Natural” Claims

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Consumer litigation surrounding “natural” food claims has increased over the last year. ConAgras Wesson Oils, Skinnygirl Margarita, and a host of other brands have had suits filed against them for using “all natural” on their labeling and in advertising. Similarly, Kelloggs popular brand, Kashi, has faced back-lash on social media sites for the use of “natural” claims on advertising and labeling. Kashi uses soy from soybeans that have had a gene inserted to protect the soybeans from the herbicide Roundup.

Neither the FDA nor any other agency has formally defined “natural.” FDA is relying on a 1993 policy that states, “[FDA] has not objected to the use of the term [natural] on food labels provided it is used in a manner that is truthful and not misleading and the product does not contain added color, artificial flavors or synthetic substances.” The plaintiffs attorneys in these cases argue that the “all natural” claim at issue is false and misleading because the product contains unnaturally processed, synthetic substances, or, in the case of Kashi, that the cereal contains genetically modified ingredients. While these products are technically in compliance with FDAs policy statement, they are not insulated against private actions because there is a lack of formal FDA or other government definition for “natural” claims. Without an FDA or other government definition, the plaintiffs attorneys can bring these suits and the food manufacturers must prove the claims are not false or misleading. Most food companies cannot afford a long drawn out lawsuit in court and end up settling. A formal FDA definition of “natural” could set a definitive standard for “natural” and eliminate these lawsuits.

A formal FDA definition of natural would not only benefit food companies, but it would also provide consumers with a clearer understanding and less confusion. For more information about the regulation of food advertising and labeling claims, please contact us at contact@fidjlaw.com or (305) 350-5690.

FDA Issues Draft Guidance on Use of Nanotechnology in Cosmetic Products

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On April 20, 2012, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a Draft Guidance for Industry entitled “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products” (the “Guidance”) which outlines the FDAs current thinking on the safety assessment of nanomaterials in cosmetic products. According to FDA, the Guidance is “intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them.”

Nanomaterials, developed using nanotechnology, can have chemical, physical, and biological properties that differ from those of their conventionally-scaled counterparts. Nanomaterials are measured in nanometers”equal to about one-billionth of a meter”and are so small that they cannot be seen with a regular microscope. While FDA has not adopted a formal definition of “nanotechnology,” “nanoscale,” or related terms, “nanotechnology” is defined by the National Nanotechnology Initiative Program as “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.” Other definitions of “nanotechnology” consider other factors such as function, shape, charge, the ratio of surface area to volume, and other physical or chemical properties.

The Food, Drug, and Cosmetic Act (“FDCA”) does not subject cosmetics or cosmetic ingredients, with the exception of color additives, to premarket review or approval in order to be legally marketed in the United States. Therefore, except for color additives and some ingredients that are prohibited or restricted by regulation, a cosmetics manufacturer may use any ingredient in the formulation of a cosmetic without obtaining FDA approval, provided that the use of the use of the ingredient does not otherwise cause the cosmetic to be adulterated under section 601 of the FDCA (21 U.S.C. § 361) or misbranded under section 602 of the FDCA (21 U.S.C. § 362). Manufacturers of a cosmetic product are responsible for making sure a cosmetic product is not adulterated or misbranded. Cosmetic manufacturers and distributors are legally responsible for the safety of the products they market and should have proper testing and substantiation to support each products safety.

The current general framework for a cosmetic products safety assessment includes hazard identification, dose-response assessment, exposure assessment, and risk characterization. FDA believes that this current system for assessing safety is appropriately robust and flexible to be applied to nanomaterials. However, cosmetics manufacturers should make sure that data and testing methods properly address the unique properties and function of nanomaterials used in the cosmetic product.

In the Guidance, FDA recommends that safety assessment for cosmetic products using nanomaterials should address the following factors:

  • The physio-chemical characteristics,
  • Agglomeration and size distribution of nanomaterials at the toxicity testing conditions which should correspond to those of a final product,
  • Impurities,
  • Potential product exposure levels, and the potential for agglomeration of nanoparticles in the final product,
  • Dosimetry for in vitro and in vivo toxicology studies,
  • In vitro and in vivo toxicological data on ingredients and their impurities, dermal penetration, irritation of the skin and eyes, sensitization studies, mutagenicity/genotoxicity studies, and
  • Clinical studies to test the ingredient, or finished product, in human volunteers under controlled conditions.

The safety of a cosmetic product with nanomaterial ingredients should be evaluated by analyzing the physio-chemical properties and toxicological endpoints of each ingredient in relation to the expected exposure levels resulting from the intended use of the finished product. FDA encourages cosmetic manufacturers to consult with the Agency to address any questions related to safety and the test methods used to substantiate a products safety.

To ensure that FDA considers comments on the Guidance when developing the final guidance, electronic or written comments should be submitted within 90 days of the publication of the notice of availability in the Federal Register. Electronic comments should be submitted to https://www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information on the FDAs regulation of cosmetics products or nanotechnology, please contact us at contact@fidjlaw.com or (305) 350-5690.

FDA Issues Draft Guidance on the Safety and Regulatory Status of Nanotechnology in Food

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On April 20, 2012, the U.S. Food and Drug Administration issued a Draft Guidance addressing the use of nanotechnology by manufacturers of food ingredients, manufacturers of food contact substances, and end users of ingredients or food contact substances. The draft guidance entitled, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives,” (“Draft Guidance”) is intended to describe the factors the food industry should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that:

  • Affects the identity of the food substance;
  • Affects the safety of the use of the food substance;
  • Affects the regulatory status of the use of the food substance; and
  • Warrants a regulatory submission to FDA.

As described by FDA in its Draft Guidance, any manufacturing change, including those involving nanotechnology, have the potential to be significant.

FDA has not formally defined “nanotechnology.” The term most commonly is used to refer to “the intentional manipulation, manufacture or selection of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.” When considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, FDA will ask:

  1. whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
  2. whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

Considerations for Assessing the Impact of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance

Before a food substance can be legally marketed in the United States, it must satisfy a safety assessment, such as obtaining premarket approval or be “generally recognized as safe” or “GRAS.” Over time, the manufacturing process for a food substance may change. If the manufacturing process changes are significant, the food substance may no longer fall within the scope of a food additive regulation, a GRAS listing, an effective food contact notification, or an existing determination of GRAS status. The Draft Guidance provides the following list of examples that may be considered by the Agency as significant changes in manufacturing processes:

  • A change in one or more starting materials;
  • A change in the concentration of starting  materials;
  • A change in catalyst;
  • A change in the source microorganism (including a change in strain) used for a food substance derived from fermentation of a microorganism; and
  • A change in food manufacturing or ingredient technology, such as the use of emerging technologies that affect the particle size distribution of a food substance.

When determining if a significant change in a manufacturing process has occurred and whether that change requires a new authorization, it is important to determine if the change has altered the identity or intended use of the food substance. In the Appendix to the Draft Guidance, FDA provides three (3) specific examples of situations in which the FDA reconsidered the regulatory status of the use of a food substance and concluded that a significant change in the manufacturing process did not negatively impact safety.

Recommendations for Assessing the Effect of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance

            The Draft Guidance provides specific steps for assessing the effect of a significant manufacturing process change on the safety and regulatory status of a food substance that is the subject of a food additive or color additive regulation in title 21 of the Code of Federal Regulation, affirmed or identified as GRAS, subject to an effective Food Contact Notification, or subject to an existing determination that a use of a food substance is GRAS. In the specific instance of nanotechnology, the Agency states, “[a]t present, for nanotechnology applications in food substances, there are questions related to the technical evidence of safety as well as the general recognition of that safety, [which] are likely to be sufficient to warrant formal premarket review and approval by FDA, rather than to satisfy criteria for GRAS status.”

Anyone can submit comments on the Draft Guidance at any time. However, in order to ensure that FDA considers comments on this Draft Guidance when developing the final guidance, electronic or written comments should be submitted within 90 days of the publication of the Notice of Availability in the Federal Register. Electronic comments should be submitted to https://www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

For more information on food ingredients and nanotechnology, please contact us at contact@fidjlaw.com or (305) 350-5690.

FDA’s Import Trade Auxiliary Communication System (“ITACS”) Now Available

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With an increased number of imports entering the United States, new enforcement initiatives under such programs as the Food Safety Modernization Act, decreasing budgets and a limited number of employees, complaints about the U.S. Food and Drug Administration (“FDA”) from the trade community have been on the rise.  One particular sore spot for the Agency is communications.  In an era of text messages, tweeting, and instant posting of documents on the internet, the FDA was still sending and receiving its messages to and from importers and brokers through fax machines and paper copies.

All of that is starting to change now.

On March 14, 2012, the FDA’s Division of Import Operations and Policy (“DIOP”) unveiled its Import Trade Auxiliary Communication System (“ITACS”) to members of the National Customs Brokers and Forwarders Association of America (“NCBFAA”).  According to FDA, the new ITACS system is being implemented in order to improve communication between FDA and the import trade community.

ITACS is an internet portal with three critical functions for importers:

  1. The ability to check on the status of an entry/lines;
  2. The ability to submit entry documentation electronically; and
  3. The ability to submit goods availability information for targeted shipments electronically.

The importance of ITACS to the trade community cannot be understated.  Using ITACS, importers and their brokers will no longer need to send or fax paper-versions of entry and goods availability documents to the FDA for their entries.  This will reduce lost documents and help eliminate the uncertainty of importers as to whether their documents were ever received by the FDA.  The automatic creation of an audit trail in ITACS means that the question of when a documents was sent and received by the FDA will no longer be in question.

ITACS is also beneficial to the trade community in that importers and brokers will be able to receive more detailed entry statuses than what are currently transmitted to filers via the U.S. Customs and Border Protection (“CBP”) Automated Broker Interface (“ABI”) system.  This will reduce the need for phone calls to the FDA district offices to check on the status of entries.  (Also, no more waiting for the FDA to return your call either.)

Finally, ITACS should reduce the confusion between importers/brokers and FDA about the date and location of shipment availability information.

The trade community is not alone in welcoming ITACS on the scene.  The new system also benefits the FDA in that it:

  • Enables FDA to focus its resources on expediting review of entries and focusing on completion of designated shipment examinations;
  • Provides all FDA staff with easy access to entry documents via FDA’s Import system;
  • Reduces the numbers of faxes, phone calls, and paper for FDA; and
  • Eliminates the need to log information in FDA’s Import system;

In its presentation to the NBCFAA entitled “ITACS:  Overview and Walkthrough of Functionality,” the FDA highlighted several important points about ITACS for the trade community to remember.  First, the availability of goods for examination should not be submitted through ITACS until the shipment has been uploaded and is physically present for FDA staff to examine.  Also, importers and filers with a current web browser and a valid CBP entry number may use ITACS.  Finally, the FDA warned that there are currently some issues with file size capacity and that documents must be in PDF format to be uploaded.  Also, ITACS will only display statuses for “open” entries.  Therefore, if a final FDA admissibility decision has been made for all lines of an entry (e.g., a release), the entry will be considered “closed” in FDA’s import system and the importer or filer will need to check the ABI Messaging or Notices of FDA Action for the status. 

We applaud the FDA’s move to improve communications between the Agency and the trade community.  We are also looking forward to the future improvements to ITACS promised by the FDA, most notably, the direct, electronic transmission of Notices of Action to both the importer and its broker (versus the paper mailings and faxes that happen today) and the ability to perform online queries for FDA Firm Identifiers and Product Codes.

The link to ITACS can be found at https://itacs.fda.gov.

For more information about the ITACS system or for assistance with the importation or regulation of your food, drug, medical device or cosmetic product, please contact the Food & Drug Law practice group at Fuerst Ittleman at 305-350-5690 or contact@fidjlaw.com.

FDA Announces it Will Not Ban BPA

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The saga surrounding BPA continues. After much ado, the U.S. Food and Drug Administration (FDA) has announced that it will not ban bisphenol A (BPA). Today the FDA denied in its entirety a citizen petition requesting that the FDA prohibit BPA has a substance for use in human food.

What is BPA?

BPA is a controversial chemical used in production of polycarbonate polymers and epoxy-based enamels and coatings. It is “an industrial chemical that has been present in many hard plastic bottles and metal based food and beverage cans since the 1960s.” An overview on BPA provided by the FDA can be found here. While past research on BPA indicated that the chemical is safe, more recent research has raised concerns relating to potential effect of BPA on the endocrine system. For instance, the “Chapel Hill” report indicated that there could be some safety concerns related to use of BPA.

The uses of BPA as a food contact chemical were approved through food additive policies prior to the enactment of FDAs food additive regulations and notification processes for food contact substances in place today. As an approved food additive, BPA can be used by any food manufacturer without prior notification to the FDA. 

Background: NRDCS BPA Battle

In August of 2008, the FDA released a draft safety assessment stating that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” Disagreeing with the FDA, the Natural Resources Defense Council (NRDC) filed a citizen petition in October of 2008 requesting that the FDA take action and banning BPA as a food additive. In January 2010, the FDA seemed to change its course when it issued its “Update on Bisphenol A for Use in Food Contact Applications,” stating that it has “some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children.”

Eventually, the FDA responded to NRDC with a form letter, stating that it lacked the resources to make a decision on the citizen petition. NRDC then petitioned the Court of Appeals for the District of Columbia Circuit to direct the FDA to render a decision. In June of 2011, the D.C. Circuit issued a ruling that it lacked exclusive jurisdiction and that the claim should be raised in district court. Persistently, NRDC filed a complaint in district court asking that the FDA be compelled to substantively respond to NRDCs petition by a specified date. Finally, in December of 2011, the FDA came to an agreement with NRDC and committed to issuing a decision on the NRDC petition by March 31, 2012.

Todays Decision

In rejecting NRDCs citizen petition in its entirety, the FDA stated that it “takes this concern seriously” but that NRDCs petition “was not sufficient to persuade FDA, at this time, to initiate rulemaking to prohibit the use of BPA in human food and food packaging.” The FDA indicated that scientific studies done on the effects of BPA in small animals cannot be applied to humans. The FDA also indicated that the sample sizes for the studies used in support of the petition may not be large enough to draw conclusive results. However, FDA has emphasized that it will continue to examine the safety of BPA and expects to issue a new update on the safety issues surrounding BPA within the next year. According to FDAs denial, the agency “is performing, monitoring, and reviewing new studies and data as they become available.”

NRDC has not announced whether or not it will take further action. Fuerst Ittleman will continue to monitor this matter and further agency announcements related to the status of BPA. For more information about the regulation of food additives and food contact substances, please contact us at contact@fidjlaw.com or (305) 350-5690.

FDA Publishes “First-of-a-Kind” Guidance for Medical Device Premarket Approval and De Novo Decisions

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On March 27, 2012, the U.S. Food and Drug Administration (“FDA”) published a “first-of-a-kind” guidance document for industry and FDA staff entitled, “Guidance for Industry and Food and Drug Administration Staff:  Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Determinations” (the “Guidance”). The Guidance is meant “to provide greater clarity for FDA reviewers and industry regarding the primary factors the FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices.” According to Jeffrey Shuren, M.D., director of FDAs Center for Devices and Radiological Health (“CDRH”), “[t]his guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations.”

The factors explained in the Guidance are applicable to devices subject to premarket approval (“PMA”) applications or de novo classification petitions. Under section 513(a) of the Food, Drug, and Cosmetic Act (“FDCA”), a PMA is the FDA process of scientific and regulatory review to evaluate the safety and efficacy of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The FDCA requires that FDA determine whether a PMA application provides a “reasonable assurance of safety and effectiveness” by “weighing any probably benefit to health from the use of the device against any probable risk of injury or illness from such use,” among several other factors. Pursuant to section 513(f)(2) of the FDCA, a de novo petition is available to sponsors of low to moderate risk medical devices that have been determined to be not substantially equivalent (“NSE”) through the 510(k) program.

According to the FDA, the Guidance:

  • Outlines the systemic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process;
  • Provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices; and
  • Describes an approach that takes into account patients tolerance for risks and perspectives on benefits, as well as the novelty of the device.

In an effort to bring much needed clarity and consistency to the review and decision-making processes for PMA and de novo submissions, the Guidance provides worksheets that the FDAs reviewers will use in making the benefit-risk. Additionally, the worksheet analysis will be described in the Summary of Safety and Effectiveness Data for PMAs and in the decision summary review memos for de novo decisions. The FDAs press release for the Guidance states, “CDRH will train medical officers, review staff managers and device reviewers on the guidance to assure the guidance is applied consistently to submissions and petitions.” The factors outlined in this Guidance will be applied to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1, 2012.

This Guidance only applies to PMA and de novo submissions but does not address any benefit-risk determination in the 510(k) decisions. We will continue to monitor the FDA to determine if it will be apply a different or the same standards in 510(k) decisions. For more information about the regulation of medical devices, including the submission of a 510(k), PMA, or de novo petition, please contact us at contact@fidjlaw.com or (305) 350-5690.

Members of Congress Unhappy with FDA Draft Guidance entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

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As we previously reported, the Food and Drug Administration (“FDA”) released a Draft Guidance for Industry entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (“the NDI Draft Guidance”), on July 5, 2011. The NDI Draft Guidance is highly controversial and, as we previously reported, many industry associations have been petitioning Congress to take action. In response, on February 29, 2012, 17 members of Congress sent a letter to Dr. Margaret Hamburg, Commissioner of the FDA, “strongly urging FDA to withdraw this guidance and begin work on a new draft that does not undermine the balance Congress struck in [the Dietary Supplement Health and Education Act of 1994 (DSHEA)] to provide consumers with access to safe, affordable dietary supplement products.”

According to the letter, the NDI Draft Guidance “seems to run counter to the will of Congress by: erecting new extra-legal barriers to market entry of dietary supplements; imposing food additive type evaluative criteria; requiring multiple New Dietary Ingredient (NDI) notifications for dietary supplements beyond those required by law; and transforming the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process.” FDA has no statutory basis for these requirements.

As two examples of how FDA has overreached, the signatories of the letter point to FDAs rejection of the industry associations prepared lists of  “grandfathered” ingredients and FDAs view that each manufacturer of a finished dietary supplement must provide a separate NDI notification. The Congressmen stated, Ëœ[i]f implemented as written, we believe that the draft guidance would overturn the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no apparent benefit for consumers.”

This letter comes on the heels of FDAs dismissal of Senator Hatchs and Senator Harkins December 22, 2011 request that FDA withdraw the NDI Draft Guidance. In their letter, Senators Harkin and Hatch, the principle authors of the DSHEA, “urge[d] FDA to withdraw this guidance and begin work on a new draft that will provide needed clarification on what constitutes a New Dietary Ingredient (NDI), but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”

Fuerst Ittleman will continue to monitor the status of the NDI Draft Guidance. For more information on how the NDI Draft Guidance may affect your company, please contact us at (305) 350-5690 or contact@fidjlaw.com.

U.S. District Court Strikes Down FDA’s Qualified Health Claim for Green Tea and Breast and Prostate Cancer

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After nine years of ongoing litigation, on February 23, 2012, the U.S. District Court for the Northern District of Connecticut struck down the U.S. Food and Drug Administrations (“FDA” or the “Agency”) proposed qualified health claim (“QHC”) regarding the relationship between green tea and the risk of breast and prostate cancer. The FDA generally requires the use of qualified health claims on a food or dietary supplement product labeling when a claim characterizes a relationship between a substance in the food or dietary supplement and a disease or health-related condition that does not meet the Agencys significant scientific agreement standard. If a manufacturer chooses to make such a claim, the manufacturer must use a disclaimer that limits or “qualifies” the statement in such a way that does not mislead consumers about the nature of the products underlying scientific support. (See the FDAs position on qualified health claims here.)

Fleminger, Inc., a manufacturer of green tea products, proposed a QHC to the FDA, which read: “Green tea may reduce the risk of breast and prostate cancers. The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.” The FDA, however, modified the proposed claim to state: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for this claim.” In its decision, the court ruled that the FDAs proposed disclaimer effectively negated Flemingers claim, and constituted an impermissible restriction on commercial speech in violation of the First Amendment. In applying the Central Hudson test, this court held that “there are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.” Furthermore, the court held that in order for the FDAs disclaimer to be constitutional, it must “strike a reasonable fit between the governments ends and the means chosen to accomplish those ends.”

As a result, the FDA must now either start anew and develop a QHC that is consistent with the courts findings or take an appeal. Although the court ultimately decided that the FDA overstepped its constitutional limitations by requiring Fleminger to use an overly restrictive qualified claim, the courts decision does not entirely disfavor the FDA. The courts decision emphasized the FDAs authority to impose appropriate disclaimers for QHCs due to the Agencys substantial interest in preventing consumer confusion and protecting the public health. In addition, the FDA is not required to permit the use of a proposed disclaimer that is inaccurate or misleading to consumers. Rather, the FDA, through its expert analysis and judgment, may use its statutory and regulatory authority to determine the appropriate level of scientific evidence required to maintain and uphold its protective goals. This case highlights the caution with which the FDA must approach its future development of QHCs. Now, courts will likely closely scrutinize the phrasing of the FDAs proposed QHCs to ensure that the Agency does not infringe on a manufacturers constitutionally protected commercial speech.

For more information on qualified health claims for food and dietary supplement products, please contact us at (305) 350-5690 or contact@fidjlaw.com.  

Rise in Consumer Litigation Challenging Advertising and Labeling Claims

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Food and dietary supplement manufacturers should be cautioned about the recent rise in consumer litigation. Over the past several years, there has been a noticeable increase in lawsuits by consumers aiming to challenge advertising and labeling claims for dietary supplements and food products.  Most recently, on February 16, a class action lawsuit was filed in a federal court in Georgia, alleging that POM Wonderful, LLC (“POM”) misled consumers by claiming “special health benefits” about its products “where such products do not, in fact, contain said benefits.” The complaint alleges that POM knowingly and willfully deceived Georgia consumers with “deceptive, misleading, false and/or misrepresentations of fact”. POM has also been targeted in similar class action suits in Florida, Kansas, Missouri, and California.

POM is the maker of POM Wonderful pomegranate products, including juices, supplements, and concentrates. According to the complaint in the latest action, POMs advertisements promoted the consumption of POM Wonderful pomegranate products as “having special health benefits, including but not limited to, the prevention, mitigation, and/or treatment of the following: atherosclerosis; blood flow/pressure; prostate cancer; erectile function; cardiovascular disease; reduce LDL cholesterol; and other age-related medical conditions.” According to the complaint, these claims are deceptive and misleading because POM had “no reasonable basis that substantiated these representation[s] at the time the representations were made. Therefore, these representations are false, misleading, and reasonably likely to deceive the public.”

In its defense, POM states that it has spent millions of dollars on its clinical research to substantiate the claims it makes about its juices and other products. POM has stated, in a September 2010 press release, that it “stands behind the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranates.” Furthermore, in the press release, POM stated that “[o]ur research is unprecedented among food and beverage companies.” Furthermore, according to the company, as of September 2010, there have been more than 55 studies on POM products, including clinical trials that have been published in peer reviewed journals to substantiate its labeling and advertising claims for its products.

Additionally, POM is involved in litigation with the U.S. Federal Trade Commission (“FTC”) regarding the level of substantiation required to support its claims. As we previously reported, on September 13, 2012, POM filed a complaint in court against the FTC alleging that the FTC has adopted a “new standard” for substantiation that it is applying to POMs claims. POM also challenged that the FTC could not require that the U.S. Food and Drug Administration (“FDA”) approve certain disease claims for a food or dietary supplement. This case is still pending in federal court.

After POM sued the FTC, the FTC sued POM within the FTC system. FTC argues that POMs claims that its products prevent, reduce the risk of, or treat heart disease, high blood pressure, prostate cancer, and erectile dysfunction (“ED”) are not supported by competent and reliable evidence. FTC filed a proposed cease and desist order that will require, among other things, FDA approval of certain claims. The case was tried before an FTC Administrative Law Judge and closing arguments were set for March 6, 2012. We will continue to watch to see how this case is resolved.

POMs trouble should be a lesson to all food and dietary supplement manufacturers to make sure their label and advertising claims are fully substantiated and not false or misleading. For more information about food and dietary supplement claims or to have Fuerst Ittleman complete a label and website review of your products, please contact us at (305) 350-5690 or contact@fidjlaw.com.