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What to know FDA regulation before Cosmetic products go on the U.S. market?

January 6 2023

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.

  • How U.S. Law Defines Cosmetics

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.

  • How U.S. Law Defines Drugs

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.

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.

The FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Violative cosmetics may be subject to seizure.

FDA can and does inspect cosmetic manufacturing facilities to assure

cosmetic product safety and determine whether cosmetics are adulterated

or misbranded under the FD&C Act or FPLA.

If you have any questions about FDA regulation of OTC Drugs and Cosmetics,

Registration and labeling compliance... , please CONTACT US.

Office 1-909-493-3276



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