Another critical function of the U.S. Food and Drug Administration (FDA) is to assure the safety of the food supply through the review of food ingredients under its food additive petition, generally recognized as safe (GRAS) notification, and food contact notification (FCN) programs. FDA also administers the new dietary ingredient notification (NDIN) program for dietary ingredients that are first marketed after passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). With the consuming public’s growing demand for plant and cell-based alternatives to traditional foods, FDA is regularly called upon to review new food ingredients developed by innovators in the field to meet this demand, and the FDA and the U.S. Department of Agriculture (USDA) are now in the midst of developing a new platform to share the review of cell-cultured meat.
We advise our clients on proper and least burdensome pathways to market new food and dietary ingredients, work closely with their scientific consultants in developing complete submission packages, advise on and manage GRAS panel composition, and assist our clients in responding to FDA inquiries throughout the process.
- Drug Product Development and Approval Strategies
- Due Diligence and Transactional Support
- Enforcement & Recalls
- Hatch-Waxman Act Litigation
- Human and Animal Food Ingredient Review and Approval Strategies
- Labeling, Advertising, and Promotion
- Litigation and Administrative Advocacy
- Medical Devices
- Regulatory Compliance
- White Collar Defense & Government Investigations