Regulation of Cosmetics by the FDA

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Regulation of Cosmetics by the FDA

In the US cosmetics are regulated by the FDA as outlined in the U.S. Food, Drug, and Cosmetic Act (FD&C Act). The law requires that every cosmetic and personal care product and its ingredients be substantiated for safety before going to market, and that they contain no prohibited ingredients.

Besides upholding the FDA regulations, however, most cosmetic manufacturers go beyond the requirements of the law and adopt additional non-governmental safety programs and technical standards established by cosmetic industry.

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) and the U. S. Attorney General can take action against any company that markets an unsafe cosmetic product. The law provides severe penalties, including seizures, recalls, fines and bans, for personal care products manufacturers that do not meet these strict safety standards. In the past, the FDA has exercised this power to limit or prohibit ingredients that it considers to be unsafe.

Cosmetic manufacturers are responsible for ensuring that products comply with the law before they are marketed. This process includes analyzing a cosmetic ingredient's testing and safety data. If the manufacturer is unable to substantiate the safety of a product, the law requires the product to carry a conspicuous warning. Check FDA website for more information.


	What the FDA Does

	Bans or restricts cosmetic ingredients for safety reasons Mandates warning labels Inspects manufacturing facilities Issues warning letters Seizes unsafe or misbranded products Enjoins unlawful activities Prosecutes and jail violators Regulates and approves Over-The-Counter (OTC) drugs used in cosmetics Works with cosmetic manufacturers in implementing nationwide product recalls Collects samples for examination and analysis as part of cosmetic plant inspections, import inspections, and follow-up to complaints of adverse reactions Conducts research on cosmetic and personal care products and ingredients to address safety concerns

	What the FDA Does Not

	Evaluates and registers new cosmetic ingredients Tests and approves individual cosmetic products

Regulation of Labeling

In addition to the Food, Drug, and Cosmetics Act, the Fair Packaging and Labeling Act authorizes FDA to require ingredient labeling of cosmetic and personal care products sold to consumers. Detailed FDA regulations govern where and how ingredients must be listed on the package. Find more detailed information about labeling regulations.

Regulation of Over-The-Counter (OTC) Drugs

The FDA has also the authority to regulate personal care products that contain active ingredients that are Over-The-Counter (OTC) drugs. OTC drugs used in personal care products including cosmetics are subject to FDA approval. Generally, drugs must either receive pre-market approval by FDA or conform to final Federal regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded.

Currently, certain but not all OTC drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final rules and regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either be the subject of an approved New Drug Application (NDA), or comply with the appropriate Federal rules for an OTC drug.

The FD&C Act defines drugs, in part, by their intended use, 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". The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term cosmeceutical has no meaning under the law. Check FDA website for more information.


	Examples of OTC Drugs Used in Cosmetics

	Antidandruff agents (e.g. in shampoos) Fluorides (e.g. in toothpastes) Sun protecting agents (e.g. in sunscreens) Antiperspirant agents (e.g. in deodorants)

Voluntary Cosmetic Registration Program (VCRP)

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US.

The VCRP helps FDA in its mission to protect consumers, gives cosmetic manufacturers and distributors access to valuable information and supports the safety evaluation of cosmetic ingredients. The greater the participation by the cosmetic industry, the better this program works and benefits companies directly through their participation.

It is important to note that the VCRP is not a cosmetic approval program! Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the company's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law.

In addition, the VCRP is not a promotional tool. It is prohibited to use VCRP participation or an assigned registration or filing number for promotional purpose. Check FDA website for more information.

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