Bryan Cave's FDA attorneys have extensive experience representing clients before FDA, the United States Department of Agriculture (USDA), FTC, and other relevant agencies. The firm represents clients in matters involving human and animal foods, functional foods, nutraceuticals, and dietary supplements.
Areas and matters with which we frequently assist these clients include:
- Reviewing health claims, nutrient content claims, structure-function claims, and dietary guidance statements
- Reviewing nutrition and organic labeling
- Monitoring compliance with USDA and CBP country of origin labeling requirements
- Representing clients in FTC proceedings (e.g., advertising claims under the Lanham Act as well as in proceedings before the National Advertising Division of the Council of Better Business Bureaus)
- Handling food safety compliance issues, including product recalls, GMPs, FDA inspection procedures and warning letters, and conducting safety assessments of food additives and ingredients
- Monitoring compliance with FDA's Hazard Analysis and Critical Control Points programs
- Monitoring compliance with the 1994 Dietary Supplement Health and Education Act (DSHEA), including advising clients on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
- Monitoring compliance with GMP guidelines
- Preparing and submitting notifications of new dietary ingredients
We also have extensive experience advising clients on pathway issues related to the approval and marketing of direct and indirect food additives as well as dietary ingredients for dietary supplements in the United States and a number of major international markets, including the EU, Latin American, and the Asian/Pacific regions. Using the client's end goal as a guideline, our attorneys and scientific staff regularly collaborate on projects from their earliest inception, assisting clients on all issues from concept to commercialization. In addition, we provide strategic advice on the content and business implications of such relevant initiatives as the EU's REACH control policy.
We frequently represent these clients with matters such as:
- Counseling on approval pathways for food additives
- Obtaining FDA approval for the use of new food additives
- Preparing and submitting food additive petitions and notifications establishing that an additive is Generally Recognized as Safe (GRAS)
- Analyzing GRAS status for food additives
- Counseling on the regulatory compliance of substances used in food packaging and processing equipment
- Preparing and submitting food contact notifications
- Analyzing GRAS status for food packaging materials and components of packaging materials
- Evaluating proposed ingredients for compliance with DSHEA
- Determining whether a proposed dietary ingredient is subject to DSHEA's new dietary ingredient notification requirements
- Preparing pre-market notifications for new dietary ingredients
- Counseling on dual pathway strategies for dietary ingredient/supplement approval in combination with food additive or drug approval