21 U.S.C. § 364h — Small businesses

(a) In general: A responsible person, or a facility owner or operator, whose average yearly U.S. cosmetics sales over the previous three years total less than $1,000,000, adjusted for inflation, counts as a small business and does not have to follow the requirements in section 364b or 364c of this title, but only if they also do not manufacture or process the products listed in (b). (b) Requirements applicable to all manufacturers and processors of cosmetics: The small-business exemption in (a) never applies to anyone who manufactures or processes: (1) cosmetics that regularly touch the mucus membrane of the eye under normal use; (2) cosmetics that are injected; (3) cosmetics meant for internal use; or (4) cosmetics meant to change appearance for more than 24 hours under normal use, where removal by the consumer is not part of normal use.