FDA Regulatory Practice

Dietary Supplements

We provide strategic counsel to the dietary supplement industry on the regulations issues under the Dietary Supplement Health and Education Act (DSHEA) which includes dietary supplement marketing, labeling, manufacturing, and advertising compliance, as well as represent clients in enforcement actions by the FDA for adulterated or misbranded products. We also review and counsel dietary supplement companies regarding compliance with DSHEA substantiation of claims requirements and assist clients in responding to FTC enforcement actions regarding false or misleading advertising. Our goal is to provide advice that will help our clients minimize regulatory challenges and maximize the speed at which they can begin marketing their products to consumers. We regularly work hand-in-hand with relevant industry groups and individual companies on important dietary supplement policy issues to ensure products receive impartial treatment by regulatory agencies.

Our attorneys assist clients on all aspects of dietary supplement development, production, and marketing:

  • Labeling and advertising review and counseling to ensure that proper dietary supplement claims are made by our clients.
  • The appropriateness of product ingredients to meet the statutory definition of dietary supplement. We also help clients determine if any of their products contain New Dietary Ingredients (NDI) and, if so, we assist in the submission of these ingredients to the FDA for review.
  • Assistance with compliance with dietary supplement current Good Manufacturing Practices (cGMPs).
  • Enforcement-related issues regarding product labeling, promotion, or adulteration violations. We represent clients for making proper responses to Form 483 inspection observations and citations for perceived cGMP violations, Warning Letters, Untitled Letters, recalls, product seizures, consent decrees, and civil or criminal violations under the Food, Drug and Cosmetic Act (FDCA). We also represent clients before the FTC regarding claim substantiation in the context of promotion and advertising that may result in a cease and desist order, consent decree, or civil penalties.
  • Drafting manufacturing, quality, distribution, and supply agreements, and evaluating investment needs for new dietary supplement product development.