How Cosmetics Are Regulated
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 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 as part of plant & import inspections
- Conducts research on 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 Cosmetic LabelingIn 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 here.
Regulation of Over-The-Counter (OTC) DrugsThe 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 for cosmetic OTC drugs are:
- 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.
Cosmetic Ingredient Review (CIR) Expert PanelThe CIR expert panel is an independent, non-profit scientific body that was launched in 1976 with support of the FDA and the Consumer Federation of America (CFA) to assess the safety of ingredients used in cosmetics in the US. The panel consists of world-renowned scientists and physicians who have been publicly nominated by consumer, scientific and medical groups, government agencies, and industry.
The CIR thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner and publishes the results of its work in peer-reviewed scientific literature. FDA, CFA and the Personal Care Products Council provide non-voting liaisons to the Panel and are actively involved in the comment and discussion process.
Personal Care Products Council (PCPC)The Personal Care Products Council, formerly known as the Cosmetic, Toiletry and Fragrance Association, is the leading national trade association for the cosmetic and personal care products industry and represents the most innovative names in beauty today. For more than 600 member companies, the council is the voice on scientific, legal, regulatory, legislative and international issues for the personal care product industry. The council is a leading and trusted source of information for and about the industry and a vocal advocate for consumer safety and continued access to new, innovative products.
Consumer Commitment CodeIn 2007, the Personal Care Products Council instituted a Consumer Commitment Code to provide consumers, regulators and other interested parties with a clear outline of the specific commitments and practices of cosmetic and personal care products companies to ensure the continued safety of all cosmetic products.
The Code incorporates and strengthens some practices already in place for most companies, such as the current reporting of manufacturing establishments; and it includes new practices such as a Safety Information Summary Program that makes information relevant to cosmetic product and ingredient safety readily available to the FDA upon request. Below is summary of the main principles of the Code; the entire text can be read at the Personal Care Product Council's website.