FDA Authority Over Cosmetics

Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect the body or skin. Cosmetics designed to enhance or alter one’s appearance (makeup) can be used to conceal blemishes, enhance one’s natural features (such as the eyebrows and eyelashes), add color to a person’s face, or change the appearance of the face entirely to resemble a different person, creature or object. Cosmetics can also be designed to add fragrance to the body.

Among the important differences between requirements for cosmetics in the United States and various other countries are the legal definitions of drugs and cosmetics, restrictions on the use of color additives and other ingredients, and registration requirements. The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “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”.

Laws that FDA Enforces for Cosmetics

1. Federal Food, Drug, and Cosmetic Act
2. Fair Packaging and Labeling ActExternal Link Disclaimer
3. Microbead-Free Waters Act of 2015
   1. Effective dates for rinse-off cosmetics: For manufacture – July 1, 2017; for introduction or delivery for introduction into interstate commerce—July 1, 2018
   2. Effective dates for products that are both rinse-off cosmetics and nonprescription drugs: For manufacturing – July 1, 2018; for introduction or delivery for introduction into interstate commerce – July 1, 2019

Laws and Regulations

Cosmetics marketed in the United States, whether manufactured here or imported from abroad, must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FP&L Act) 15 USC Ch. 39; 16 CFR Chapter 1 Subchapter E, and the regulations published under the authority of these laws.

The regulations published by the Food and Drug Administration (FDA) are all codified in Title 21, Code of Federal Regulations (21 CFR). The regulations related to cosmetics are stated at 21 CFR, parts 700 to 740 (21 CFR 700 to 740). The color additive regulations that apply to cosmetics are found at 21 CFR 73, 74, 81 and 82.

Cosmetic Registration

Cosmetic companies may register in the United States through FDA’s Voluntary Cosmetic Registration Program (VCRP). The VCRP assists FDA in carrying out its responsibility to regulate cosmetics. FDA uses the information to evaluate cosmetic products on the market. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution.

Cosmetic Labeling

The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper. FP&L Act requirements, e.g., ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container. The labeling requirements are codified at 21 CFR 701 and 740.

The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10), must state the name of the product, identify by descriptive name or illustration the nature or use of the product, and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation. The net quantity of contents statement of a solid, semisolid or viscous cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof. If the net quantity of contents is one pound or one pint or more, it must be expressed in ounces, followed in parenthesis () by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces). The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.

Assuring Ingredient and Product Safety

Cosmetics imported into the United States, both ingredients and finished products, must meet the same criteria for safety and labeling as those manufactured domestically.

FDA does not pre-approve cosmetic products or ingredients, with the important exception of color additives. However, cosmetic firms are responsible for marketing safe, properly labeled products; using no prohibited ingredients; and adhering to limits on restricted ingredients. It is also considered good practice to follow industry safety guidelines and recommendations.

Before marketing a product containing a color additive in the United States, it is essential to determine whether the additive is approved for its intended use. A number of color additives must be certified for purity in FDA labs if they are to be used legally in a product marketed in the United States.

Although U.S. regulations do not specify any particular testing regimens for cosmetic products or ingredients, it is the cosmetic company’s responsibility to substantiate product and ingredient safety prior to marketing.