Andrew S. Ittleman

Andrew S. Ittleman is a Founder and Partner of Fuerst Ittleman David & Joseph. He concentrates his practice in the areas of White Collar Criminal Defense, Anti-Money Laundering Compliance and Food and Drug Law. Mr. Ittleman litigates extensively against the United States government in civil and criminal matters.

PRACTICE AREAS

• Anti-Money Laundering
• FDA
• White Collar Defense
• Corporate
• Litigation and Arbitration

Overview

Andrew S. Ittleman is a founding partner of Fuerst Ittleman David & Joseph. He is an attorney and Certified Anti-Money Laundering Specialist providing strategic representation to a wide variety of regulated businesses, their executives and officers, and other related individuals. Mr. Ittleman values long-standing relationships with his clients, ideally working with them as startups with cutting edge ideas, through their fundraising, licensing and development stages, and finally providing holistic representation once they are operational and commercializing regulated products and services. For certain clients, Mr. Ittleman serves as their fractional Ethics and Compliance Officers (ECO), with the ability to draft, implement, administer and train compliance programs touching on a variety of legal and regulatory areas. In all cases Mr. Ittleman’s clients rely on him for practical, strategic, time sensitive, complex legal advice on an as-needed basis.

Mr. Ittleman’s clients are primarily regulated by the United States Food & Drug Administration (FDA), the Financial Crimes Enforcement Network (FinCEN), or the regulators in the individual states which share jurisdiction with their federal counterparts. Mr. Ittleman also counsels a wide range of companies in the healthcare and medical tourism industries, as well as importers and exporters of a wide range of products and services, all of which are foundational industries in Miami. In order to best serve his clients, Mr. Ittleman has developed a strong working knowledge of the Food Drug & Cosmetic Act (FDCA), the regulations and policies drafted and implemented by FDA, the Bank Secrecy Act, the anti-money laundering regulations and policies drafted and implemented by FinCEN, the federal statutes and regulations governing medical kickbacks, referrals, and self-referrals, and state laws governing healthcare, financial services, and medical products. Additionally, as a fractional compliance officer, Mr. Ittleman routinely advises clients on anti-money laundering requirements, antitrust prohibitions and best practices, domestic and foreign anti-corruption issues (including FCPA), as well as the United States sanctions laws and regulations administered by the United States Treasury Department’s Office of Foreign Assets Control (OFAC).
Mr. Ittleman’s diverse and expanding list of representative clients and cases include the following:

Financial Services

Mr. Ittleman has represented a broad range of domestic and international financial and money services businesses (MSBs), including:

• Money transmitting businesses;
• Check cashing businesses;
• Currency exchangers;
• Foreign exchange (ForEx) dealers;
• Prepaid card and other prepaid access providers;
• Payment facilitators (PayFacs) and Independent Sales Organizations (ISOs);
• Cryptocurrency dealers, exchangers and issuers, both online and via ATM machines; andFinancial technology (FinTech) firms.

Mr. Ittleman has represented his financial services and MSB clients in the following capacities:

• Regulatory counseling, including by assisting early stage financial services and FinTech firms understand state, federal and international regulations, as well as by assisting clients make strategic business decisions in light of overarching regulatory concerns;
• Anti-money laundering counseling, including by advising MSBs regarding marijuana-related business (MRB) and other high risk customers;
• Stock and asset purchase agreements, including by conducting regulatory due diligences on behalf of purchasers of entities and assets;
• Agency, foreign affiliate, and other cooperation agreements between regulated financial institutions;
• Website and mobile application User Agreements, Terms of Service and Privacy Policies, including by advising clients regarding their use of customer information;
• CFPB disclosure requirements;
• OFAC sanctions regulations, including most recently the U.S. government’s Venezuelan sanctions program and its shifting policies governing remittances to Cuba;
• Entity formation, including by drafting and negotiating governing documents and employment agreements;
• Money transmitting license applications;
• Commercial litigation;
• White collar criminal defense and grand jury investigations involving allegations of money laundering, operating unlicensed money transmitting businesses, CMIR violations, and related allegations of wrongdoing;
• Government (civil) enforcement litigation;
• Law enforcement relations, including by assisting domestic and international clients respond to grand jury subpoenas and Mutual Legal Assistance Treaty (MLAT) requests;
• State and federal enforcement actions, including administrative complaints filed by FinCEN, CFTC, and state-level financial services regulators;

Mr. Ittleman has also advised multinational banks and domestic credit unions develop policies and procedures for their banking of MSBs, FinTech firms, marijuana related businesses, and other high risk accountholders.

FDA

Mr. Ittleman focuses his FDA practice in the following key areas:

• Regenerative Medicine: Mr. Ittleman is a sought after thought leader and advisor for a wide variety of companies in the regenerative medicine industry. Mr. Ittleman began his work in the regenerative medicine industry in 2007, and since that time has developed an exhaustive understanding of FDA’s Part 1271 regulations, guidances and policies, as well as FDA’s administrative record dating back to 2003. Mr. Ittleman’s regenerative medicine clients most often include individual physicians and closely held organizations focused on the research, development, and use of autologous stem cell therapies, which involve the use of a patient’s own cells and tissue to address the patient’s medical condition. Mr. Ittleman is most notable for his representation of regenerative medicine clients focusing on orthopedic conditions and injuries, but has also provided strategic counseling services for a wide range of other practitioners, researchers and scientists. Additionally, Mr. Ittleman has represented numerous medical device manufacturers and distributors, focusing on products that process, manipulate and store human tissue for subsequent medical use.
• Beyond the regenerative medicine industry, Mr. Ittleman has represented numerous other domestic and international FDA regulated businesses, including those involved in the development, manufacturing and distribution of medical devices, drugs, dietary supplements, cosmetics, and medical foods.

Mr. Ittleman regularly represents his FDA regulated clients in the following capacities:

• Regulatory counseling, including by advising early stage firms regarding FDA regulations and policies, as well as by assisting his clients make strategic decisions in light of FDA regulations and policies;
• Compliance counseling, including by advising FDA regulated businesses in their development of compliance policies, focusing on:
  • Marketing, including by advising clients regarding appropriate marketing claims on a product-by-product basis, for instance by focusing on FDA’s Part 1271 regulations and its historic policies governing dietary supplement advertising;
  • Off-label marketing and advertising; and
  • Anti-Kickback, patient brokering, and other patient referral and business generation best practices and policies;
• Stock and asset purchase agreements, including by conducting regulatory due diligences on behalf of purchasers of entities and assets;
• Licensing agreements, allowing his clients to mobilize their proprietary procedures and technologies by licensing them to other practitioners;
• Informed consents;
• Commercial litigation;
• Government enforcement litigation;
• White collar criminal defense and grand jury investigations;
• Enforcement actions, including by assisting clients with FDA inspections, observations of violations (FDA 483s) and by spearheading responses to FDA warning letters and untitled letters;
• Entity formation;
• Product license and clearance applications, as well as Emergency Use Authorization (EUA) applications.

Additionally, the Federal Trade Commission (FTC) has overlapping jurisdiction with FDA based on a Memorandum of Understanding (MOU) first published in 1954. Mr. Ittleman has advised his FDA regulated business clients regarding FTC’s requirements governing “truthful and substantiated” advertising, and has represented them in their responses to FTC Civil Investigative Demands (CIDs) and in litigation against FTC regarding alleged violations of the Federal Trade Commission Act.

Healthcare

Mr. Ittleman has represented a wide array of healthcare providers and practitioners, including physicians, surgery centers, hospitals, nursing homes, home health agencies and skilled nursing facilities, as well as manufacturers and distributors of medical products used by healthcare providers and practitioners. Mr. Ittleman’s representation of these clients has included the following:

• Strategic counseling regarding patient referral and business generation efforts, with a particular focus on federal and state anti-kickback and patient brokering statutes, regulations, policies, and safe harbors;
• Drafting, reviewing and negotiating contracts between and among healthcare providers, as well as their executives, employees, contractors and related individuals, focusing on federal and state anti-kickback and self- referral (Stark) patient brokering statutes, regulations, policies, and safe harbors;
• Drafting and implementing compliance policy documents and programs;
• Informed consents;
• Commercial litigation;
• White collar criminal defense and grand jury investigations;
• False Claims Act and Qui Tam actions, including by representing recipients of False Claims Act Civil Investigative Demands;
• Relators in False Claims Act matters

Medical Tourism

Mr. Ittleman has provided critical legal services to numerous medical tourism facilities and related businesses. Mr. Ittleman’s medical tourism clients typically provide medical treatments that are either unavailable in the United States, or better and more cost effective abroad. In most instances, Mr. Ittleman’s medical tourism clients are founded by American physicians and entrepreneurs, and to date he has advised these clients launch medical tourism clinics located in Mexico, The Bahamas, Panama, Costa Rica, The Cayman Islands and other international jurisdictions. Because these medical tourism clinics are launched by U.S. persons and entities, and often market to American patients, Mr. Ittleman is asked to coordinate and oversee a broad range of legal projects and issues, either to comply with or avoid triggering U.S. law. Mr. Ittleman’s work for his medical tourism clients has included the following:

• Advising medical tourism clients regarding patient referral and business generation issues, with a particular focus on federal and state anti-kickback and patient brokering statutes, regulations, policies, and safe harbors;
• Drafting, reviewing and negotiating agreements between and among international medical tourism clinics, their executives and employees, as well as service providers, consultants and referral sources in the U.S.;
• Advising U.S. medical tourism facilitators, including by drafting their User Agreements and Terms of Service, as well as the contracts governing the relationships between medical tourism facilitators and international medical tourism facilities;
• Drafting and implementing medical tourism compliance programs and policy documents;
• Commercial litigation and arbitrations.

Miami International Trade Attorney

The South Florida economy is built largely on international trade, with entire towns (such as Doral) dotted by warehouses for the import and export of commercial goods. Since the earliest days of his professional career, Mr. Ittleman has represented Miami importers and exporters in a wide array of circumstances. Most notably, Mr. Ittleman has developed a strong understanding of Miami’s export economy, which is perhaps best known as an intermediary between U.S. manufacturers and South American purchasers. For example, many South American computer and electronics retailers are unable to purchase merchandise directly from U.S. manufacturers, due to the unusual credit risk they often present. Thus, many Latin American entrepreneurs in Miami have filled this void, by purchasing merchandise from the U.S. manufacturers, and then selling to the South American retailers, taking on the credit risk that the U.S. manufacturers are unwilling to absorb. Over the years, this has become a critical Miami industry, but also one fraught with risk. For instance, Doral has become known as a hotbed for “trade based money laundering,” based on widespread reports of American goods being substituted for cash and wire transfers as an ideal method of remitting the proceeds of the drug trade to South America. As a Certified Anti-Money Laundering Specialist, Mr. Ittleman understands these risks, has developed compliance programs to help clients remain compliant with U.S. money laundering laws, and has litigated against the state and federal government in criminal and civil forfeiture actions where all of these laws are at issue.

Some of Mr. Ittleman’s representative clients and cases as a Miami International Trade Attorney are as follows:

• Represented South American computer and electronics retailer and related U.S. exporter in a criminal investigation involving allegations of money laundering, smuggling, and tax evasion;
• Advised U.S. mobile phone exporter and Central American purchasers regarding U.S. money laundering laws, and the development of a multi-dimensional compliance program;
• Drafted and implemented anti-money laundering programs, including cash handling and due diligence policies and procedures, for multiple Miami area exporters;
• Served as lead counsel in state and federal civil forfeiture actions, both on behalf of property owners and innocent third parties.

Fractional Compliance Officer

Mr. Ittleman has been able to put his Anti-Money Laundering Specialist certification and compliance know how to good use over the years, including by serving as a fractional compliance officer for clients in the international trade industry. As a fractional compliance officer, Mr. Ittleman has drafted and implemented compliance policies touching on a wide array of important legal issues. Additionally, Mr. Ittleman regularly trains company personnel all over the world regarding the policies, the rules and restrictions they contain, and their reporting functions. In many cases, this requires Mr. Ittleman to effectively teach foreigners about nuanced areas of U.S. law and the risks involved, which he enjoys doing through real world case studies and down-to-earth explanations. Further, as a fractional compliance officer, Mr. Ittleman makes himself available in real time on an as needed basis to address compliance questions raised by company personnel worldwide. Mr. Ittleman has drafted and implemented compliance policies in the following areas:

• Anti-money laundering;
• Anti-corruption, including the Foreign Corrupt Practices Act (FCPA)
• Antitrust;
• Government contracting requirements;
• International sanctions, including the sanctions regulations drafted and implemented by OFAC, governing trade between the United States and Iran, North Korea, Syria, Cuba, Venezuela, Russia, Crimea, Sudan and numerous other jurisdictions.

Mr. Ittleman was born in Philadelphia, Pennsylvania and raised in Cherry Hill, New Jersey. He holds a Bachelor of Arts degree from Emory University and received his law degree from the University of Miami Law School in Miami, Florida. Mr. Ittleman is licensed to practice law in the State of Florida, and admitted to practice before the United States Supreme Court, the United States Courts of Appeals for the Third, Eighth, Tenth, Eleventh, D.C. and Federal Circuits, and the United States District Courts for the Southern and Middle Districts of Florida, the District of Colorado, the Northern District of Illinois, the Western District of Michigan, the United States Court of Federal Claims and the United States Tax Court. Mr. Ittleman has also represented clients pro hac vice in the United States District Courts in the District of Columbia, the Central and Northern Districts of California, the District of Montana and the District of New Jersey. Mr. Ittleman has been certified as an Anti-Money Laundering Specialist (CAMS) by the Association of Certified Anti-Money Laundering Specialists (ACAMS) since 2006, is a member of the Advisory Board of the International Money Transfer Conferences, and assisted with the founding and creation of the Money Services Business Association (MSBA). Mr. Ittleman is a frequent writer and lecturer for domestic and international trade groups, and is regularly quoted in major print and digital media publications, including the Wall Street Journal, Washington Post, Bloomberg, Vice, the Miami Herald, the Daily Business Review, The Real Deal, Al Jazeera, CoinDesk, The Street, The Verge and many others.

Education

• University of Miami School of Law Coral Gables, Florida J.D.
• Emory University, Atlanta, Georgia, B.A .

Admitted

• United States Supreme Court
• Florida
• United States Court of Appeals for the Federal Circuit
• United States Court of Appeals for the District of Columbia Circuit
• United States Court of Appeals for the Tenth Circuit
• United States Court of Appeals for the Eighth Circuit
• United States District Court for the Southern District of Florida
• United States District Court for the District of Colorado
• United States Tax Court
• United States Court of Federal Claims
• United States District Court for the Northern District of Illinois

Memberships

• Association of Certified Anti-Money Laundering Specialists
• National Money Transmitters Association
• National Association of Criminal Defense Lawyers

Speaking Engagements

• Moderator, Cross Border Industry Trends, IMTC World, November 17, 2021
• Speaker, Ten Takeaways in Ten Minutes for the Twelfth TOBI, TOBI Orthobiologics Symposium, October 9, 2021
• Panelist, Anti-Money Laundering, Marcum Compliance and Fraud Summit, October 7, 2021
• Speaker, Regulatory Briefing for the Regenerative Medicine Industry, Gulfcoast Ultrasound Institute, August 19, 2021
• Panelist, Latest Fines & Sanctions: What We Need to Learn, Regliance, June 10, 2021
• Speaker, “FDA/Regulatory Landscape in 2021,” American Medical Society for Sports Medicine (AMSSM), Annual Meeting, April 14, 2021
• Speaker, “Regulatory Briefing for the Regenerative Medicine Industry,” American Academy of Orthopedic Medicine (AAOM), Virtual Conference Series: Cutting Edge Solutions for Cutting Edge Physicians, December 6, 2020
• Speaker, “Understanding FDA’s Emergency Use Authorizations – For Your Patients and Your Practice,” doctor.com Webinar, May 27, 2020
• Speaker, “Regulatory Briefing for the Regenerative Medicine Industry,” Interventional Orthopedics Foundation, Broomfield, Colorado, February 14, 2020
• Panelist, “How do we work together in the current regulatory framework,” World Stem Cell Summit, Miami, Florida, January 22, 2020
• Speaker, “Current Regulatory Landscape,” World Academy of Pain Medicine Ultrasonography (WAPMU): Frontiers in Pain Practice – Peripheral Nerve Stimulation and Regenerative Medicine, Coral Gables, Florida, February 15, 2019
• Speaker, “Controversies in Orthobiologics” (feat. Regulatory Fireside Chat); Interventional Orthopedics Foundation Annual Conference, Broomfield, Colorado, February 8, 2019
• Speaker, “Maintaining a Compliant Medical Tourism Practice in a Shifting Regulatory Environment,” HEALinc Future Health Innovation Summit, Nassau, Bahamas, October 7-9, 2018
• Panelist, FDA Enforcement Panel, ACI’s FDA Boot Camp, Boston, Massachusetts, September 27-28, 2018
• Speaker, “The New FDA Guidance Documents and Clinic Crackdown – What Does it Mean?” (feat. Special Regulatory Q&A Session); Interventional Orthopedics Foundation Annual Conference, Broomfield, Colorado, February 15, 2018
• Speaker, “Regenerative Medicine: Understanding FDA’s New Approach to the Regulation of Stem Cells and HCT/Ps,” FDANews Webinar, February 8, 2018
• Chair, Panelist, “Navigating the Legal Minefield – What Clinicians and Patients Need to Know Before Undertaking a Cell-Based Therapy Treatment,” World Stem Cell Summit, Miami, Florida, January 25, 2018
• Speaker, “Legal Hot Topics & Penalty Actions,” IMTC World, Miami, Florida, November 30, 2017
• Panelist, Legends of the Boardroom – Medical Marijuana Panel, Dade County Bar Association, Miami, Florida, October 20, 2017
• Speaker, “Take it to the Bank – The Mysteries of Banking Regulations,” State Bar of Michigan – Marijuana Law Section, Detroit, Michigan, September 9, 2017
• Speaker, “A Regulatory Briefing for the Regenerative Medicine Industry,” Boston Biolife, Philadelphia, Pennsylvania, July 15, 2017
• Speaker, “FDA Regulation of Orthobiologics,” The Orthobiologics Institute (TOBI), Las Vegas, Nevada, June 10, 2017
• Panelist, “FinTech and Your Bank – Risks and Integration,” BSA Coalition Anti-Money Laundering Conference, Federal Reserve Bank of Richmond, Richmond, Virginia, June 6, 2017
• Speaker, “The 21st Century Cures Act and the Future of Regenerative Medicine,” FDANews Webinar, March 2, 2017
• Speaker, “Regulatory Briefing for the Regenerative Medicine Industry,” Interventional Orthopedics Foundation Annual Conference, Broomfield, Colorado, February 17, 2017
• Speaker, “Federal Regulation of Marijuana Related Businesses,” Broward County Bar Association Marijuana Legalization Summit, February 10, 2017
• Panelist, “Developing, Implementing, and Maintaining AML, Terror Finance and Fraud Deterrence Programs That Will Provide a Competitive Advantage and Pass Muster in Today’s Enforcement Environment, Without Negatively Impacting the Customer/User Experience,” ACI’s National Forum on Emerging Payment Systems, Washington, DC, September 15-16, 2016
• Panelist, “The Evolving Federal Regulatory and Enforcement Paradigm: Practical Guidance and Best Practices for Complying with New Mandates from the Key Federal Agencies Overseeing Emerging Payment Systems,” ACI’s National Forum on Emerging Payment Systems, San Francisco, California, July 28-29, 2016
• Speaker, “Regenerative Medicine: Understanding the Regulatory Landscape,” Life Science Training Institute, Webinar, July 21, 2016
• Speaker, “United States Regulation of Money Transmitting Businesses,” International Money Transfer Conference, Havana, Cuba, June 27, 2016
• Speaker, “Maintaining a Compliant Medical Tourism Practice in a Shifting Regulatory Environment,” Regenera Global: International Conference Redefining Regenerative Medicine, Freeport, Bahamas, June 23-25, 2016
• Speaker, “FDA Regulation of Regenerative Medicine: Risks and Opportunities in a Shifting Regulatory Environment,” FDANews Webinar, June 9, 2016
• Speaker, “International Regulation of Regenerative Medicine” and “FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps),” A4M Metabolic Medical Institute, Hollywood, Florida, May 19-21, 2016
• Host, Moderator, Presenter: MTBIT: Remittances & Blockchains, International Money Transfer Conference, Las Vegas, Nevada, March 14, 2016
• Panelist, “Park Doctrine, Individual Liability, and the Yates Memo,” FDLI Enforcement Conference, Washington, DC, December 10, 2015
• Speaker, “How US Law Regulates Non-US Bitcoin Companies,” Latin American Bitcoin Conference, Mexico City, Mexico, December 4, 2015
• Panelist, “An Examination of Virtual Currency as a Decentralized Product and as an Alternative Method to Traditional Banking,” ACI’s Advanced Legal, Regulatory, and Compliance Forum on Cross Border & Global Payments and Technologies, New York, NY, November 19-20, 2015
• Host, Moderator, Presenter: MTBIT: Remittances & Blockchains, International Money Transfer Conference, Miami, Florida, November 9, 2015
• Presenter, “Banking Marijuana Related Businesses,” 11th Annual Anti-Money Laundering, Compliance and Financial Crime Conference, Grand Cayman, Cayman Islands, October 8-9, 2015
• Presenter, “A Survey of FDA’s Regulation of HCT/Ps,” Alliance for the Advancement of Cellular Therapies, Chicago, IL, September 18, 2015
• Presenter, “Banking Marijuana-Related Companies,” KAW Management Services Ltd., 7th Annual AML/CFT, Anti-Fraud and Financial Crimes Conference, St. John’s, Antigua, July 14, 2015
• Presenter, “FDA Regulation of Autologous Stem Cell Procedures,” Age Management Medicine Group, Orlando, Florida, April 23, 2015
• Event Chair and Moderator, “Risks and Opportunities in the Budding Marijuana
• Industry,” Greater Miami Jewish Federation, Miami, Florida, April 21, 2015
• Presenter, “Personal Liability & Penalties for Export Violations,” Export Compliance Training Institute, Webinar, March 5, 2015
• Panelist, “Regulatory Panel,” The Fourth North American Bitcoin Conference, Miami, FL, January 17, 2015
• Presenter, “FDA Regulation of HCT/Ps from Adipose Tissue,” American Academy of Cosmetic Surgery, New Orleans, LA, January 15, 2015
• Panelist, “Money Transmission and Remittances,” Latin American Bitcoin Conference, Rio de Janeiro, Brazil, December 7, 2014
• Presenter, “How United States Law Affects Non-U.S. Financial Institutions,” Latin American Bitcoin Conference, Rio de Janeiro, Brazil, December 6, 2014
• Presenter, “Banking Marijuana-Related Companies,” ACAMS & ACFE South Florida Chapter 2014 AML/Fraud Conference, Miami, Florida, November 7, 2014
• Presenter, “Understanding Virtual Currencies,” IMTC World, Miami, Florida, October 7, 2014
• Host, Moderator, Presenter: “Virtual Currencies & Alternative Payments Certification Course,” IMTC World, Miami, Florida, October 6, 2014
• Panelist, “Bitcoin: Where Is It Going and What Should You and Your Clients Know,” Greater Miami Jewish Federation, Fall Seminar, Miami, Florida, September 19, 2014
• Host, Moderator, Presenter, “Bitcoin Workshop,” IMTC USA, San Diego, CA, June 25, 2014
• Panelist, “Understanding Mt. Gox,” Texas Bitcoin Conference, Austin, TX, March 5, 2014
• Panelist, “Bitcoin and Regulation,” Texas Bitcoin Conference, Austin, TX, March 6, 2014
• Presenter, “United States Regulation of Autologous Stem Cell Procedures,” Stemso, Freeport, Bahamas, February 20, 2014
• Presenter, “United States Regulation of Autologous Stem Cell Procedures,” New York Stem Cell Summit, New York, NY, February 18, 2014
• Presenter, “The Lay of the Land for Money Services Businesses,” National Money Transmitters Association, Industry Symposium for Legislative Action, Washington, DC, February 18, 2014
• Panelist, “Shades of Gray: Collateral Consequences of Risky Promotional Activities: False Claims Act,” Food and Drug Law Institute (FDLI) Advertising & Promotion Conference, Washington, D.C., September 17, 2013
• Presenter, “The Importance of Management in the Casino AML Infrastructure,” Florida Department of Business and Professional Regulation Anti-Money Laundering Conference, University of Miami, Coral Gables, FL, August 23, 2013
• Panelist, “Are Regulations Keeping Pace with Payment Technologies and the Market?,” International Money Transfer Conference (Los Angeles), April 4, 2013
• Panelist, “Are Stem Cells Drugs?,” New York Stem Cell Summit, New York, New York, February 18, 2013
• Panelist, “Ethical Patient Recruitment and Marketing,” STEMSO International Stem Cell Society, Fort Lauderdale, Florida, February 6-8, 2013
• Presenter, “FDA’s Regulation of Autologous Stem Cell Procedures,” STEMSO International Stem Cell Society, Fort Lauderdale, Florida, February 6-8, 2013
• Presenter, “Purchasing Injectables: A Risk Analysis,” American Academy of Cosmetic Surgery, Annual Scientific Meeting (Las Vegas, Nevada), January 17, 2013; discussed in “Savings vs. Safety,” MedEsthetics Magazine, March/April 2013
• Presenter, “Physicians’ Use of Autologous Stem Cell Procedures,” American Academy of Cosmetic Surgery, Annual Scientific Meeting (Las Vegas, Nevada), January 16, 2013
• Presenter, “Autologous Stem Cell Procedures: Resolving the Disconnect between FDA and Medical Practitioners,” The Food & Drug Law Institute (FDLI), Washington, D.C., November 29, 2012
• Panel Member: Autologous Stem Cell Therapies are Not Drugs: Houston Stem Cell Summit, October 27, 2012
• Panel Member: A Federal Money Transmitting License: International Money Transfer Conference (Miami), October 25, 2012
• Presenter, “How United States Law Affects Non-U.S. Financial Institutions,” International Money Transmitters Conference (Los Angeles), May 30 – June 1, 2012
• Presenter, “Regulation of a Physician’s Use of Adipose Stem Cells,” Ninth Annual Symposium on Adipose Stem Cells and Clinical Applications of Adipose Tissue, International Federation for Adipose Therapeutics and Science (IFATS), November 4-6, 2011
• Presenter, “The Evolving Definition of Money Transmitting Business,” International Money Transmitters Conference (Los Angeles), April 13-15, 2011
• Presenter, “How United States Law Affects Non-U.S. Financial Institutions,” International Money Transmitters Conference (Miami), October 17-19, 2010
• Presenter, “The Defenders Tale: War Stories from the Field,” International Money Transmitters Conference (Miami), October 4-6, 2009 (available here)
• Panel Member, “Legal Issues Impacting MSBs: Recent Developments,” International Money Transmitters Conference (Miami), September 22-23, 2008
• Panel Member, “Ask the Experts: Money Transmitters and Money Laundering Prosecutions,” International Money Transmitters Conference (Miami), November 3-5, 2007
• Presenter, “Money Laundering, Security and Business: What are the Implications,” Spain – United States Chamber of Commerce, June 28, 2007

Publications

• “Strengthening the Stem Cell Industry Through Better Regulation,” University of Pennsylvania Regulatory Review, April 6, 2021
• “Legal Issues: Risks of Foreign-Sourced Injectables” (The ever-present risk of FDA enforcement necessitates due diligence when investigating new injectable suppliers), MedEsthetics Magazine, November 2, 2020
• “Legal Issues: Mitigating Losses” (Legal guidance to help practices mitigate coronavirus-related losses and return safely to work), MedAesthetics Magazine, May 26, 2020
• “Key Takeaways from the Insys Prosecution,” Daily Business Review, June 12, 2019
• “How FDA Should Use Its Authority to Regulate Human Cells,” University of Pennsylvania Regulatory Review, October 30, 2017
• “The Money Services Banking Crisis: A Complex Solution for a Simple Problem,” Daily Business Review, June 20, 2016
• “DOJ Changing of the Guard Could Impact Corporate Compliance,” Daily Business Review, March 29, 2016
• “Practical Applications of the Yates Memorandum for the U.S. Food Industry,” Food and Drug Law Institute Update Magazine, January/February 2016
• “What FinCEN’s Geographic Targeting Order Means,” Daily Business Review, May 8, 2015
• “FDA and Autologous Medicine,” MedEsthetics Magazine, May/June, 2015
• “Federal Marijuana Regulation: Why is Flexibility Critical in the Dawn of Legalization?,” Food and Drug Law Institute Policy Forum, Vol. 4, Issue, 12, December 19, 2014
• Co-authored, “When the World Innovates But the Law Stands Still”, South Florida Legal Guide, Mid Year 2014.
• Co-authored, Bitcoin Taxation: Understanding IRS Notice 2014-21,” Bitcoin Magazine, April 4, 2014
• Co-authored, Marijuana Taxation Update: IRC § 280E — An Albatross For the Marijuana Industry,” Law360.com, March 19, 2014
• Co-Author of Need for Regulatory Harmonization: How FDA and FTC’s Shared Jurisdiction Poses Problems for Labeling & Advertising Compliance, FCN Committee Newsletter (A.B.A. Section of Science & Technology Law: Food, Cosmetics and Nutraceuticals), Winter 2014, at 2, 8-11.
• “Hurdles in Accessing Banking Services,” South Florida Legal Guide, 2013 Financial Edition
• Co-authored, “Chapter XII – FDA Enforcement Actions: Potential Consequences of Non-Compliance” in FDLI Primer FDA’s Regulation of Veterinary Drug Products, (2013).
• Featured in, “Savings vs. Safety: The FDA is cracking down on physicians who purchase injectables from non-U.S. suppliers,” MedEsthetics Magazine, March-April, 2013
• FDLI: Food and Drug Policy Forum: Enforcement Discretion: How Can FDA More Reasonably Regulate Autologous Stem Cell Procedures, Vol.2, Issue 24, December 26, 2012
• Inside the Minds: Recent Developments in Food and Drug Law: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-to-Date with FDA Requirements, and Developing Compliance Practices, 2013 Edition: “The FDA’s Regulation of Autologous Stem Cell Therapies”
• Forbes.com: “Cash Is King,” March 18, 2008