The following is an introduction to how cosmetics are regulated under U.S. law, and how these laws may be different from those in other countries.
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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. Some products regulated as cosmetics in Europe, for instance, are regulated as drugs in the United States. Sunscreens are a case in point. There also are differences regarding prohibited and restricted ingredients, particularly color additives. Some countries may require cosmetic companies to register their establishments and list products and ingredients with the government; in the United States, cosmetic registration is voluntary but highly recommended.
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." Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
The FD&C Act defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...and articles (other than food) intended to affect the structure or any function of the body of man or other animals." Over-the-counter (OTC) drugs are drugs that can be purchased without a doctor's prescription.
The agency is conducting a review of all OTC drugs to establish monographs (rules) under which the drugs are generally recognized as safe and effective, and not misbranded. These rules are established on a class-by-class basis (for example, fluoride dentifrices, cough suppressants, and antihistamines). OTC drugs must meet the requirements of the appropriate class once that rule is published as a final regulation.
If an OTC drug does not meet the requirements of the appropriate final rule, it is considered a misbranded drug and a "new drug." A "new drug" must have an approved New Drug Application (NDA) before it may be introduced into interstate commerce. In addition, drug manufacturers must comply with Good Manufacturing Practice regulations.
Certain claims may cause a product to qualify as a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.
OTC drugs are often marketed side by side with cosmetics, and some products qualify both as cosmetics and as OTC drugs. This may happen when a product has two intended uses, with ingredients intended to do two different things. For instance, a shampoo is a cosmetic, since its intended use is to cleanse the hair. An anti-dandruff treatment is a drug, because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.
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.
Cosmetic companies may register in the United States through FDA's Voluntary Cosmetic Registration Program (VCRP). If a cosmetic manufacturer files a product formulation with the VCRP, FDA can advise the company if it is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In that way, manufacturers can correct their formulations before attempting to market them in the United States, thus avoiding the risk of having their products detained and denied entry into the United States because of a prohibited ingredient.
- Color Additives Permitted for Use in Cosmetics