Claim: The powers of the FDA are limited when it comes to the cosmetics industry.
FDA: For an overview of FDA’s regulation of cosmetics, see “FDA Authority over Cosmetics”
It’s important for consumers to realize that, under the FD&C Act, FDA does not evaluate cosmetic products before they go on the market and that manufacturers are responsible for marketing a safe product. The FDA can take action if it has evidence of safety issues, and encourages consumers to file a report with the Agency if they experience an adverse event.
The manufacturer is responsible for marketing a safe product and for conducting appropriate assessments to satisfy that requirement.
Unlike other cosmetic ingredients, color additives, with the exception of coal tar hair dyes, are subject to FDA premarket approval. A color additive is defined as any dye, pigment or substance that is capable of imparting color to a food, drug, or cosmetic (21 CFR 70.3(f)). This definition also applies to black, white, and intermediate grays. However, if an color additive is used solely for a purpose other than coloring, and if “the material is used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned,” it would not be considered a color additive (21 CFR 70.3(g)).
Product recalls of cosmetics, as with almost all FDA-regulated products, are voluntary on the part of the manufacturer. With the exception of infant formula and certain medical devices, FDA does not have the authority to recall products.
The FDA can only regulate products once they have been released to the public.
The FDA does regulate cosmetics, as addressed in the previous answer. While the agency does not evaluate products prior to marketing, it does set standards for safety and labeling that manufacturers must abide by. It also requires the approval of color additives before they can be used in products.
Claim: The FDA has only banned less than a dozen ingredients for use in products.
FDA: Some ingredients are prohibited or restricted from use in cosmetics by regulation.
Manufacturers may essentially use any ingredient not on the list above (except color additives, discussed above) in the formulation of a cosmetic product provided that the ingredients and the finished products are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded.
For the majority of products the FDA relies on outside testing as a source.
The FDA does utilize the Cosmetic Ingredient Review (CIR) Expert Panel in determining its priorities for ingredient safety review. The CIR is an independent, industry-funded panel of scientific experts that regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. FDA representatives attend CIR meetings in a non-voting capacity.
Claim: Manufacturers are not required to disclose all of the ingredients and byproducts that are in products.
FDA: Cosmetic products marketed on a retail basis to consumers in the U.S., whether manufactured domestically or imported, must bear an ingredient declaration on their product package label, in which all ingredients down to 1% concentration are listed in descending order of predominance. Fragrance ingredients may be listed simply as “fragrance,” rather than listing fragrance components individually. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA). Because the FPLA applies only to products marketed on a retail basis to consumers, the requirement for an ingredient declaration does not apply in other cases, such as to cosmetics marketed only to professionals, or only for institutional or workplace use, or distributed as free samples.
Claim: Regulations in Europe are a lot stricter than in the US.
FDA: It is not appropriate for the FDA to comment on European regulations and whether they are more or less stringent than the U.S.
Claim: By law the FDA has no authority to force a recall of a cosmetic even after public safety issues are raised.
FDA: Product recalls of cosmetics, as with almost all FDA-regulated products, are voluntary on the part of the manufacturer. With the exception of infant formula and certain medical devices, FDA does not have the authority to recall products.
Claim: Cosmetics companies are not required to register with the FDA, report the ingredients they use or send the FDA safety-testing data.
FDA: FDA has a Voluntary Cosmetic Registration Program. The information received by FDA from the VCRP is 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 manufacturers and distributors of affected products by using a mailing list (or email list if you participate via Internet) generated from the VCRP database.
With regard to safety data, cosmetic manufacturers must be able to substantiate the basis for the safety profile of their products.
Claim: Cosmetic companies are only required to list intended ingredients, not byproducts and contaminants.
FDA: Cosmetic products marketed on a retail basis to consumers in the U.S., whether manufactured domestically or imported, must bear an ingredient declaration on their product package label, in which all ingredients down to 1% concentration are listed in descending order of predominance.
Claim: The fragrance industry is not required to list the ingredients in their formulas.
FDA: Perfumes and other similar products such as colognes, toilet waters, eau de parfum or eau de cologne, among others, are required like other cosmetics to bear an ingredient declaration on their product package labeling. “Fragrance” may be declared as such, without listing each individual component. Substances added to the formulated fragrance for their technical function in the final product (such as fixatives, vehicles, solvents, light stabilizers, or color additives) must be listed in the ingredient declaration. Under the law and FDA regulations, a manufacturer may elect to declare additional ingredient information but is not required to do so.