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 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 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 Panel
The
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 Code
In 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.