The requirement that “food facilities” register with the FDA is a provision of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”). Dietary supplements are classified as “food” under the Food, Drug and Cosmetic Act (FDCA) as well as under Section 1.227 of the Bioterrorism Act. Therefore, dietary supplement companies that manufacture or warehouse supplement products must be registered with the FDA:
Title 21 – Chapter 1 – Subchapter A – Part 1 – Subpart H:
Section 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for one of the exemptions in 1.226.
(b) If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce.
(c) If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf.
Section 1.227 What definitions apply to this subpart?
4) Food has the meaning given in section 201(f) of the act (21 U.S.C. 321(f)),
(ii) Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. [emphasis added]
If your facility is not yet registered with the FDA or you need to update the information on file with the FDA, visit: Registering your facility with the FDA. Collins, McDonald & Gann is also available to answer your questions about registration, in order to ensure that your company satisfies its legal obligations under federal law.