Regulation of the Cosmetic Industry

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Who regulates the Cosmetic Industry?

We hear about laws and regulations over food and drugs, but what about the cosmetic industry?  In the United States the Cosmetic Industry is regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act, codified into Title 21 Chapter 9 of the United States Code) and the Fair Packaging and Labeling Act (FPLA), which were enacted over 75 years ago.  I used to think that if products were on the market they were safe and had to go through some kind of approval before I could buy them.  However, I was shocked to discover the cosmetic industry does not have strict laws to protect consumers.

The law does not require FDA premarket approval for cosmetic products and ingredients, like drugs, biologics and medical devices.  The FDA only does premarket approval for color additives.  This means a cosmetic manufacturer may use any ingredient in the formulation of a cosmetic, except for color additives and ingredients that are prohibited or restricted by a regulation.  Under the law, the ingredient and finished cosmetic still needs to be safe under labeled or customary conditions of use, properly labeled, and the ingredients can not cause the cosmetic to be adulterated or misbranded under the laws the FDA enforces.  This basically means the FD&C Act prohibits manufactures from using poisonous or deleterious substances, packaged and prepared under insanitary conditions rendering it injurious to health, or has false or misleading labeling.  This is why so many beauty and personal care products available to us have toxic ingredients and chemicals of concern.

Under the FD&C Act cosmetics are defined by their intended use (FD&C Act sec. 201(i).  The products included are:

  • Skin moisturizer
  • Perfumes
  • Lipsticks
  • Fingernail polishes
  • Eye and facial make-up
  • Cleansing shampoos
  • Permanent waves
  • Hair colors
  • Deodorants

The FD&C Act and the FPLA or FDA regulations do not require companies to demonstrate the safety of individual products or ingredients.  The companies and individuals who manufacturer or market the cosmetics have a legal responsibility to ensure their products are safe, but the laws do not require the cosmetic companies to share their safety information with the FDA.  Also, the laws do not give the FDA authority to recall cosmetics, the manufactures or distributors may take voluntary actions to recall their product if they are hazardous or defective.  Although the FDA doesn’t have authority to mandate a recall of a cosmetic, it can request that a firm recall a product.

We have a right as consumers to have safe products available to us all.  Until the FDA is granted further authority, we need to be diligent about checking our products for ingredients/chemicals of concern and we can demand the cosmetic industry and law makers pass stricter laws for safer products.

Resources: FDA, Office of the Law Revision Counsel United States Code Title 21, Chapter 9


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