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 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
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