Modernization of Cosmetics Regulation Act 2022
The act (https://www.congress.gov/bill/117th-congress/senate-bill/4348/text#toc-id892EB13582A94F5DAD4DA611C1E88DC4) establishes GMP’s, registration of facilities, formal approval of ingredients, safety substantiation etc.
Small business are largely exempt (see below), BUT NOT from safety substantiation of products (“ensure and maintain records supporting”)-
“(1) ADEQUATE SUBSTANTIATION OF SAFETY.—The term ‘adequate substantiation of safety’ means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
“(a) In General.—Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.
“(b) Requirements Applicable To All Manufacturers And Processors Of Cosmetics.—The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:
“(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.