Food, Beverage and Dietary Supplements
Our Food & Beverage attorneys represent clients before the FDA, USDA, FTC, or other related agencies. Whether you need assistance with human and animal foods, functional foods, beverages, nutraceuticals, or dietary supplements, we are prepared to:
- Review health claims, nutrient content claims, structure-function claims, and dietary guidance statements
- Review nutrition and organic labeling
- Monitor compliance with USDA and Customs and Border Protection country of origin labeling requirements
- Represent you 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)
- Handle food and beverage safety compliance issues, including product recalls, Good Manufacturing Practices (GMPs), FDA inspection procedures and warning letters, and conducting safety assessments of food and beverage additives and ingredients
- Monitor compliance with FDA’s Hazard Analysis and Critical Control Points programs
- Monitor compliance with the 1994 Dietary Supplement Health and Education Act (DSHEA), including advising on general labeling and advertising issues, nutrition labeling, and evaluation of permissible claims (e.g., health claims, nutrient content claims, and structure-function claims)
- Monitor compliance with GMP guidelines
- Prepare and submit notifications of new dietary ingredients
We also assist with pathway issues relating to the approval and marketing of direct and indirect food and beverage additives and dietary ingredients for dietary supplements in the United States, the European Union (EU), Latin American, and the Asian/Pacific regions. We work with you to define your objectives and goals and determine an optimal outcome. With that outcome in mind, we join forces with scientific staff on projects from inception, assisting your company from concept to commercialization. In addition, we advise on the content and business implications of the EU’s Registration, Evaluation and Authorization of Chemicals (REACH) control policy.
We provide counseling on approval pathways for food and beverage additives and help you obtain FDA approval for the use of new food and beverage additives. We also prepare and submit food and beverage additive petitions and notifications establishing that an additive is Generally Recognized as Safe (GRAS), and analyze for GRAS status for food and beverage additives, food and beverage packaging materials, and components of packaging materials. We offer counseling on the regulatory compliance of substances used in food and beverage packaging and processing equipment and can help you prepare and submit food and beverage contact notifications.
If you require DSHEA assistance, we evaluate proposed ingredients for compliance and determine whether a proposed dietary ingredient is subject to DSHEA’s new dietary ingredient notification requirements. We also prepare pre-market notifications for new dietary ingredients and counsel on dual-pathway strategies for dietary ingredient/supplement approval in combination with food and beverage additive or drug approval.