REGULATIONS 79
Regulation of cosmetic products in US
Dr Martin Perry – Advanced Development and Safety Laboratories Limited, UK
This article aims to give an overview of how cosmetics are regulated in the United States of America. It looks at the Federal Food, Drug and Cosmetic Act, The Fair Packaging and Labeling Act, adulterated and misbranded cosmetics, colour additives, sunscreen products, and the role of the Food and Drug Administration.
Cosmetic, drug, or both? The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics in terms of their intended use. Cosmetic products are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human
body...for cleansing, beautifying, promoting attractiveness, or altering the appearance”.1 The Federal Food, Drug, and Cosmetic Act specifically excludes soap from the definition of “cosmetic”. Some products can be both a cosmetic and a drug if they have more than one function. For example antidandruff shampoos, toothpastes that contain fluoride, deodorants that are also antiperspirants, and products which are marketed with a sun protection claim are classed as both cosmetics and drugs. The claimed intended use of a product can also determine whether a product is a cosmetic or drug. Claims such as restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells would make a product a drug and not a cosmetic. Fragrances which are marketed to promote attractiveness are cosmetics but a fragrance marketed with aromatherapy properties such as aiding sleep would be a drug. Similarly a massage oil which is marketed to lubricate and fragrance the body is a cosmetic but if its intended use is to relieve muscle pain then it is a drug.
How are cosmetics regulated? Cosmetic products are regulated both at the federal level and the state level. At the federal level cosmetic products must comply with the Federal Food, Drug, and
April 2018
Cosmetic Act, The Fair Packing and Labelling Act and the regulations published by the Food and Drug Administration under the authority of these two pieces of legislation. The Federal Food, Drug, and Cosmetic Act is contained within Title 21 Chapter 9 of the United States Code of Federal Regulations (21 CFR). The regulations that apply to cosmetic products are 21 CFR parts 700 to 740 and 21 CFR parts 73, 74, 81 and 82.
Fair Packaging and Labeling Act Cosmetic products must be labelled in accordance with The Fair Packaging and Labeling Act. The act requires that the label states the identity of the product; the name and place of business of the manufacturer, packer, or distributor; and the net quantity of the contents of the product. The Food and Drug Administration has published guidance on the labelling of cosmetic products in their cosmetic labelling guide.2 This guidance also includes labelling requirements for cosmetics which are also drugs.
Food and Drug Administration (FDA) The Federal Food, Drug, and Cosmetic Act prohibits the marketing of adulterated or misbranded cosmetics.3
Cosmetic products
and ingredients with the exception of colour additives do not require pre-market approval by the Food and Drug Administration. The Federal Food, Drug, and Cosmetic Act does not require manufacturers to share safety data for ingredients or cosmetic products with the Food and Drug Administration. A manufacturer may use any ingredient in a cosmetic product except for colour additives and ingredients that have been prohibited or restricted provided that the use of the ingredient does not cause the cosmetic product to be adulterated or misbranded. The Food and Drug Administration cannot order a cosmetic product to be recalled but can request that the manufacturer or distributor recalls it. When a product is recalled the Food and Drug Administration plays an active role by monitoring the progress of the recall, evaluating any health hazard and ensuring
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