Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IV — FOOD › § 350
Stops the federal food official from setting upper strength limits, from calling a vitamin or mineral a drug just because it is stronger than the official thinks is useful, and from restricting how many or which vitamins, minerals, or other ingredients can be put together in certain dietary foods. Those limits can still apply if the product is sold for treating or managing specific diseases or disorders, if it is sold for children (children means under the age of twelve years), or if it is sold for pregnant or breastfeeding women. Says these covered foods aren’t automatically treated as mislabeled just because they list ingredients or advertise ingredients that are not vitamins or minerals. Labels may not single out non‑dietary‑supplement ingredients except as part of the full ingredient list and only as rules require; special exceptions can be made if following that rule is impractical or unfair. Defines the covered foods as special dietary foods for people that contain vitamins or minerals and are meant to be taken in tablets, capsules, powders, softgels, gelcaps, or liquids, or that aren’t sold as ordinary food and aren’t sold as the only item of a meal or diet. Liquid form means a fluid taken in daily amounts measured in drops or similar small units. "Special dietary use" covers uses like medical or life‑stage needs (for example disease, pregnancy, infancy, allergies, underweight or overweight, or sodium control), to add vitamins or minerals to the diet, or to serve as the sole food in a diet.
Full Legal Text
Food and Drugs, Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 350
Title 21, Food and Drugs
Last Updated
Sep 23, 2026
Release point: 119-110