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The firm advises and represents clients with respect to a wide range of regulatory activities involving dietary supplements of vitamins and minerals, herbs, and other substances used to supplement the diet. 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.
Representative Matters
- Representing one of the leading trade associations in the dietary supplement industry on legislative and regulatory matters, including working with the association and its members on pending regulatory issues such as cGMPs for dietary supplements, and pending legislative issues such as mandatory serious adverse event reporting for dietary supplements.
- Working with the firm’s 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 National Advertising Division of the Council of Better Business Bureaus).
- Advising dietary supplement manufacturers on such issues as the use of the internet for marketing, the use of the "non-label" provision of the Federal Food, Drug, and Cosmetic Act for promotional purposes, and conducting detailed reviews of proposed and existing labels and other promotional materials.
Accolades
- PLC Cross-border Super League (2005-2008)
- Ranked 1st in the Life Sciences Industry Super League
- Ranked 1st in the Life Sciences Regulatory Super League
- PLC - Life Sciences, Which Law Firm? (2006-2007)
- Leading: Regulatory firm, EU and USA
- PLC awarded Covington the Best International Practice Award 2006 in the life sciences area.
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