By law, FDA does not have the authority to approve cosmetic products or ingredients, except for color additives. However, regulations prohibit or restrict the use of several ingredients because of safety concerns.
In addition, cosmetic and fragrance trade associations have recommended avoiding or limiting the use of some substances. Contaminants raise additional concerns. The following is an introduction to special safety and regulatory issues related to cosmetic ingredients.
It is the responsibility of the manufacturer and distributor to assure the safety of each ingredient and finished product. Without substantiation of safety, Title 21 of the Code of Federal Regulations (21 CFR), Part 740.10 requires that the product carry the following warning on the label:
"Warning: The safety of this product has not been determined."
Regulations specifically prohibit or restrict the use of the following ingredients in cosmetics. For complete details, refer to the relevant regulations (21 CFR, Parts 250.250 and 700.11 through 700.23):
In the early 1970s, FDA received a number of complaints of personal injury associated with the use of fingernail extenders containing methyl methacrylate monomer. Among these injuries were reports of fingernail damage and deformity, as well as contact dermatitis. On the basis of its investigations of the injuries and discussions with medical experts in the field of dermatology, FDA concluded that liquid methyl methacrylate was a poisonous and deleterious substance that should not be used in fingernail preparations. The agency chose to remove products containing 100 percent liquid methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls.
Although there is no specific regulation prohibiting the use of liquid methyl methacrylate monomer in cosmetic products, FDA continues to believe that this substance, when used in cosmetic fingernail preparations, is a poisonous and deleterious substance.
In addition to the ingredients that are controlled by regulation or were the subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting maximum levels of certain ingredients associated with health risks. For example, the Cosmetic Ingredient Review (CIR) Expert Panel, an independent panel of scientific experts, regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. (The CIR was established by the Cosmetic, Toiletry, and Fragrance Association.) According to its 1999 Annual Report, CIR has found the following ingredients unsafe:
CIR also has recommended limits for the use of a number of other ingredients. You can contact CIR at:
Cosmetic Ingredient Review
1101 17th St. N. W. Suite 310
Washington D. C. 20036-4702
phone: 202-331-0651 fax: 202-331-0088
Web site: www.cir-safety.org
Similarly, the International Fragrance Association (IFRA) establishes usage guidelines for fragrance materials. IFRA's Code of Practice currently recommends against the use of more than 30 substances as fragrance materials and advises limiting the use of many more. Among the many that IFRA recommends avoiding are:
The IFRA member organization in the United States is:
Fragrance Materials Association (FMA)
1620 I St., NW, Suite 925
Washington, DC 20006
Phone: (202) 293-5800
Fax: (202) 463-8998
The risk of introducing contaminants into a product is always a concern in cosmetic manufacture, whether they are introduced through contaminated raw ingredients or form during the manufacturing process. Nitrosamines and dioxane are among those contaminants that may form during the manufacturing process and raise safety issues. Research also has raised safety questions about diethanolamine (DEA) and related ingredients that may contain residual levels of this substance.
FDA expressed its concern about the contamination of cosmetics with nitrosamines in a notice published in the Federal Register of April 10, 1979 (44 FR 21365). It stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action.
Cosmetics containing as ingredients amines or amino derivatives, particularly diethanolamine, or ingredients that are derived from diethanolamine or possibly contain diethanolamine as a contaminant, may form nitrosamines if they also contain an ingredient that acts as a nitrosating agent, such as 2-bromo-2-nitropropane-1,3-diol (Bronopol), 5-bromo-5-nitro-1,3-dioxane (Bronidox L) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos, and cream hair conditioners. Nitrosamines are avoidable by proper formulation: by not using amines or amino derivatives in combination with a nitrosating agent and by testing the product under use conditions to make sure that nitrosamines do not form under customary conditions of use.
Cosmetics containing as ingredients ethoxylated surface active agents, including detergents, foaming agents, emulsifiers and certain solvents identifiable by the prefix, word, or syllable "PEG," "Polyethylene," "Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol-," may be contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost.
Although cosmetic manufacturers are not required to register with FDA, companies are encouraged to register their establishments and list their products and ingredients through the agency's Voluntary Cosmetic Registration Program (VCRP). If a cosmetic manufacturer files a product formulation with the VCRP, FDA can advise the manufacturer if he or she is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In this way, manufacturers can correct their formulations before attempting to import or distribute them, thus avoiding the risk of detention or recall due to ingredient-related violations. Products containing prohibited ingredients are not accepted into the registration program.
The information received by FDA from the VCRP is evaluated and entered into a computer database. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the product's manufacturer or distributor by using a mailing list generated from the VCRP database. If your products are not in the registration database, you won't be on the notification mailing list.
Hypertext updated by dms 2001-JUN-14