The firm advises and represents clients with respect to a wide range of regulatory activities involving dietary supplements comprising vitamins and minerals, herbs, and other substances used to supplement the diet. These representations go back over fifty years to the first major FDA challenges to the industry and have involved all the statutory changes, including the 1994 Dietary Supplement Health and Education Act (DSHEA), which created both opportunities and new issues for our clients. These issues have included the interpretation of the statutory definition of “dietary supplement,” the application of the “new dietary ingredient” criteria, and the continuing issue of the line between permitted “structure or function” claims and impermissible “disease” claims.
In addition, we advise on general labeling issues, GMP compliance, and the distinction between labeling and advertising. Some of our clients are pharmaceutical companies accustomed to complying with FDA requirements, while others are direct-selling marketers and start-up companies requiring significant counseling on FDA requirements, statutory provisions, and the risks involved in the regulatory process.
- We represent one of the leading trade associations in the dietary supplement industry on legislative and regulatory matters, including coordinating industry comments to the Food and Drug Administration and the U.S. Congress on issues of key importance such as serious adverse event reporting requirements and cGMPs, and urging appropriate restraints on the unlawful marketing of drug ingredients in purported dietary supplements to help ensure the integrity of the industry.
- We work with our dietary supplement marketing clients on such matters as new dietary ingredient regulation, the crafting and submission of “structure/function” claims for dietary supplements, the evaluation of the substantiation for supplement claims, and representation of these clients in proceedings before Federal, State, and voluntary regulators (such as the NAD).
- We advise dietary supplement manufacturers on such issues as the “new” or “grandfathered” status of dietary ingredients, the creation of internet libraries of scientific research under the “non-label” provision of the Federal Food, Drug, and Cosmetic Act, and the evaluation of substantiating evidence for claims.
- We have conducted detailed reviews of proposed and existing labels and other promotional materials.
- We provided regulatory advice and due diligence on the $3.8 billion acquisition of the major dietary supplement company, NBTY.
- We defended a dietary supplement and food marketer in an FTC investigation.
- We represent clients in responding to FDA warning letters for dietary supplements.
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2013)
- Life Sciences, Global-wide
- Life Sciences, Europe-wide
- Chambers USA (2013)
- Life Sciences, Nationwide
- Food & Beverages, Regulatory & Litigation, Nationwide
- Life Sciences, CA
- Chambers UK (2013)
- Life Sciences, UK-wide
- Life Sciences, Product Liability, UK-wide
- Life Sciences, Regulatory, UK-wide
- Product Liability, Food, UK-wide
- Chambers Asia (2013)
- Life Sciences (International Firms), China
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading; Government Enforcement and Investigations, USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Highly Recommended: Life Sciences, Belgium
- Legal 500 US (2013)
- Healthcare – Life Sciences
- Legal 500 EMEA (2013)
- LMG Life Sciences (2012)