Actually the answer is no. They do not.
There are laws in place but they are both limited and vague. The law currently governing the cosmetics industry is called the Federal Food, Drug and Cosmetics Act (FD&C Act).
Below I will break it down and pick apart the very questions that can be found on the government paged called FDA Authority Over Cosmetics.
Here it goes:
1. What kinds of products are “cosmetics” under the law?
The Answer: The FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FD&C Act, sec. 201(i)). Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
The Problem: The problem lies within the last part of that statement, “as well as any substance intended for use as a component of a cosmetic product” – aka “cosmetic ingredients.” There are about 12,000 ingredients that go into our personal care products and only 80% of them have been tested for safety. Europe and other countries have banned 1300 of them but the US has only banned 11.
2. Does FDA approve cosmetics before they go on the market?
The Answer: No. Cosmetic products and their ingredients do not need FDA premarket approval, with the exception of color additives. The FDA can file a lawsuit against a company for violation of the FD&C Act which states that a manufacturer may use any ingredient in the formulation of a cosmetic, provided that
- the ingredient and the finished cosmetic are safe under labeled or customary conditions of use,
- the product is properly labeled, and
- the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
The Problem: You are complying with the FDA provided that (below are the three points above in layman’s terms….)
- everyone else is uses it, why do I need to stop (otherwise known as “customary law”)
- the ingredient is listed on the label therefore it must be safe
- and the ingredient doesn’t interfere with the performance that the product promises
None of this has anything to do with safety obviously.
3. Who is responsible for substantiating the safety of cosmetics?
The Answer: Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA.
FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.” (Federal Register, March 3, 1975, page 8916).
In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.
The Problem: THE COSMETIC INDUSTRY IS SELF REGULATED! (Yes I’m yelling!)
This is my favorite picture of me yelling:
The Answer: No. Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective (21 CFR 7.40(a). FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA’s written request. To learn more, see “FDA Recall Policy for Cosmetics.”
The Problem: THE COSMETIC INDUSTRY IS SELF REGULATED! (yelling again!)
The Answer: FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
The Problem: One word. Vague. They can. But do they? And how do they know they are safe if so many of the ingredients inside have never been tested. Hmmmm…..
6. Does FDA test cosmetics or recommend testing labs?
The Answer: Although FD&C Act does not subject cosmetics to premarket approval by FDA, we do collect samples for examination and analysis as part of cosmetic facility inspections, import inspections, and follow-up to complaints of adverse events associated with their use. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.
FDA does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, we do not recommend private laboratories to consumers or manufacturers for sample analysis.
The Problem: They might check stuff and maybe after an adverse reaction. And a conflict of interest to get things tested.
The Answer: No. Under the law, manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics into the United States.
However, we encourage cosmetic firms to participate in FDA’s Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database. To learn more and access this program, see Voluntary Cosmetic Registration Program (VCRP).
The Problem: It seems like there is a lot of advising and encouraging going on. Effective?
Ok. That’s all I can take. There will be more to come!
Please let me know your thoughts on this. Thank you!