FDA regulates both finished dietary supplement products and dietary ingredients under specific regulations aside from those covering “conventional” food and drug products (both prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling Dietary Supplements. However, manufacturers must make sure that product label information is truthful and not misleading.
The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market Dietary Supplements that contain “new dietary ingredients” notify the FDA about these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.
Under the FDA Final Rule 21 CFR 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control. In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.
The FDA attorneys and consultants of C. Humphrey & Associates, P.A. represent domestic and international companies who manufacture, hold and distribute Dietary Supplements. Our FDA law firm provides regulatory representation regarding a range of regulatory food law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of food product development and marketing.
Our FDA law firm counsels clients regarding compliance with a variety of statutory and regulatory requirements and guidance documents covering Dietary Supplements including:
- Labeling and advertising in compliance with FDA and FTC requirements
- Website Review for Dietary Supplements
- Development and implementation of marketing strategies including “Third Party Literature” (under section 5 of DSHEA), that may be used to substantiate disease/drug claims
- Structure/function claims for Dietary Supplements
- Health claims and qualified health claims for Dietary Supplements
- Nutrition information (e.g. Supplement Facts)
- Food allergen labeling for Dietary Supplements
- New Dietary Ingredient (NDI) and Old Dietary Ingredient (ODI) opinions
- Preparation of New Dietary Ingredient Notifications
- Establishment registrations under The Bioterrorism Act, including acting as U.S. agent for foreign facilities
- Recordkeeping and records access for Dietary Supplements
- FDA Import Alerts for Dietary Supplements
- Assessing the classification of products as Dietary Supplements
- Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls
- FDA Dietary Supplement inspections
- Submission of 403(r)(6) Notifications to the FDA for Statements of Nutritional Support
- Providing guidance on safety testing of Dietary Supplements including toxicology, carcinogenic and sample testing
- Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA criminal and civil penalties for Dietary Supplements)
- Response to National Advertising Division (NAD) inquiries for Dietary Supplements