Amin Talati advises and represents clients with a wide range of regulatory activities involving dietary supplements of vitamins and minerals, herbs, and other substances used to supplement the diet. Since the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) amendments to the FD&C Act, we have helped clients interpret and comply with the regulations.
Our Dietary Supplement Services Include:
- Advising on the classification of products as dietary supplements
- Advising on all aspects of labeling and advertising in compliance with FDA and FTC requirements
- Counseling on compliance issues relating to good manufacturing practices, record keeping, product recalls, market withdrawals and FDA inspections
- Developing permitted product claims with respect to structure/function and disease claims
- Filing 403(r)(6) Notifications to the FDA for Statements of Nutritional Support
- Providing New Dietary Ingredient (NDI) and Old Dietary Ingredient (ODI) opinions
- Preparing and Filing New Dietary Ingredient Notifications
- Developing and implementing key marketing strategies such as “Third Party Literature” (under section 5 of DSHEA), that may be used to substantiate disease/drug claims
- Providing guidance on safety testing of dietary supplements including toxicology, carcinogenic and sample testing
- Defending against FDA and FTC enforcement actions