16 CFR 1500.81 - Exemptions for food, drugs, cosmetics, and fuels.
(a)Food, drugs, and cosmetics. Substances subject to the Federal Food, Drug, and Cosmetic Act are exempted by section 2(f)(2) of the act; but where a food, drug, or cosmetic offers a substantial risk of injury or illness from any handling or use that is customary or usual it may be regarded as misbranded under the Federal Food, Drug, and Cosmetic Act because its label fails to reveal material facts with respect to consequences that may result from use of the article ( 21 U.S.C. 321(n)) when its label fails to bear information to alert the householder to this hazard.
(b)Fuels. A substance intended to be used as a fuel is exempt from the requirements of the act when in containers that are intended to be or are installed as part of the heating, cooling, or refrigeration system of a house. A portable container used for delivery or temporary or additional storage, and containing a substance that is a hazardous substance as defined in section 2(f) of the act, is not exempt from the labeling prescribed in section 2(p) of the act, even though it contains a fuel to be used in the heating, cooking, or refrigeration system of a house.