Dietary supplements are foods under the Federal Food, Drug and Cosmetic Act (FDCA), with additional legal obligations imposed by the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Dietary supplement manufacturers, importers and distributors (foreign or domestic) are not required to obtain approval from the U.S. Food and Drug Administration (FDA) before marketing supplements to consumers. However, these parties are subject to an array of regulatory obligations in order to ensure (1) the dietary supplement is safe, (2) product claims are not false or misleading, and (3) the dietary supplement complies with all FDCA/DSHEA requirements and FDA regulations.
Issues of particular concern for dietary supplement manufacturers, importers and distributors are (1) dietary supplement good manufacturing practices (cGMPs) as outlined in 21 CFR Part 111, (2) ingredient safety, (3) nutrition labeling as outlined in 21 CFR 101.36 and Part 101, (4) label and labeling compliance, (5) advertising – including social media networks, (6) facility registration requirements and (7) dietary supplement notification filings.
An addition to the dietary supplement landscape involves recent efforts by the FDA, in conjunction with the U.S. Department of Justice (DOJ) and various state actors to ramp up investigation into dietary supplement manufacturers, importers and distributors’ compliance programs. The FDA, DOJ and state actors are becoming increasingly concerned with dietary supplement safety and efficacy. Recently, the FDA created the new Office of Dietary Supplement Programs (ODSP) to enhance the effectiveness of dietary supplement regulation. Additionally, the DOJ responded by commencing more than 100 civil and criminal actions against manufacturers, distributors and retailers for fraud. New York Attorney General Eric Schneiderman is ramping up efforts to bring state actions against these actors. All actors in the dietary supplement supply chain should be on alert for potential litigation exposure.
Armstrong Teasdale attorneys have significant experience advising the dietary supplement industry, especially regarding the ever-changing enforcement priorities. Our attorneys serve as close advisors, guiding companies of all sizes, from startups to Fortune 100 companies, step-by-step through the complex regulatory regime. Our ultimate goal is to help our clients grow market share while managing the increasing regulatory burdens and judicial actions impacting the dietary supplement industry.
Our dietary supplement advisors assist with:
- New Dietary Ingredient premarket notification submission and requirements
- Bulk ingredient safety compliance
- Dietary supplement Standard Operating Procedures (SOPs)
- Adverse event reporting and liability management
- Compliance with dietary supplement current cGMPs and best practices
- Label and labeling reviews, advertisements, Internet marketing and social media networks for your dietary supplement
- Dietary supplement claim substantiation
- Audits of your operations and associated risk assessment related to non-compliance
- Ingredient safety reviews and dietary ingredient counsel
- Defense against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state and federal prosecutors for violation of safety regulations, and for false labeling and advertising
- U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, and import/export guidance
- Analysis and advocacy with respect to relevant legislation and dietary supplement regulatory matters
- Obtaining patents and trademarks, and gray market protection strategies