009-U.S. FDA Foods

U.S. FDA Food

  1. Food Facility Registration

You must register before your facility begins to manufacture, process, pack, or hold food for consumption by human or animal in the United States. You must submit a registration renewal containing the information required under 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. Facility located outside of U.S. must authorize an US agent to complete the registration process.
(21CFR 1.230)

  1. Dietary Supplement<

The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.
Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, soft gels, gel caps, powders, and liquids
(the FD&C Act (21 U.S.C 321(ff)(1)의 section 201(ff)(1))

  1. New Dietary Ingredient Notification<

The term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 350b(d)). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a “new dietary ingredient” and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.
If you plan to market a dietary supplement that contains a new dietary ingredient and the new dietary ingredient has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.
(21 CFR §190.6.)

  1. Labeling<

Labeling for dietary supplement must indicate “Supplement Facts” instead of “Nutrition Facts” of food. Labeler may emphasize specific ingredient and/or feature of the dietary supplement through Nutrient Content Claim.
(21 CFR 101.13(b))

  1. FCE, SID Process Registration<

Manufacturers seeking to produce and distributes Low acid food (pH greater than 4.6, water activity 0.85 or below), and high acid food (pH 4.6 or below, water activity greater than 0.85), which need heat processing, must complete FCE registration (Food Canning Establishment Registration) and SID (Submission Identifier) as well as facility registration beforehand.
(21 CFR 108.25(c)(1), 21 CFR 108.35(c)(1))