Bill Proposes FDA Regulation of Cosmetics
May 5, 2015
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The New York Times reported on April 20  that a new bill has been proposed that aims to give the Food and Drug Administration (“FDA”) more oversight over the regulation of the cosmetics industry.

The Bill

The bipartisan bill is co-sponsored by Senators Dianne Feinstein, Democrat of California, and Susan Collins, Republican of Maine. As reported by the Times, the proposed bill would give the FDA the authority to force recalls of dangerous products. The bill would also require companies to report “serious” adverse health effects, such as death or hospitalization, they hear about from consumers within fifteen business days. Companies would be required to report “nonserious” events, such as rashes, in an annual report.


What Counts as a “Cosmetic?”

The Food, Drug and Cosmetics Act describes cosmetics 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.” This includes products such as:

  • skin moisturizers
  • perfumes
  • lipsticks
  • fingernail polishes
  • eye and facial makeup
  • cleansing shampoos
  • permanent waves,
  • hair colors
  • and deodorants

The definition also includes any substance intended for use as a component of a cosmetic product. However, it does not include soap. This is in contrast to a drug or medical device, which is a product intended for a therapeutic use, such as treating or preventing disease or to affect the structure or function of the body. Other “personal care products” may be regulated as dietary supplements or as consumer products.

The FDA has Little Control

Since the passage of the Food, Drug and Cosmetic Act in 1938, the FDA has had little authority over regulating the cosmetics industry. According to Slate, at the FDA’s inception, the cosmetics industry lobbied heavily to keep the FDA from regulating it. Currently, the FDA can only ask manufacturers to voluntarily recall defective or harmful cosmetic products, but the FDA cannot force a recall. Cosmetics manufacturers are also not legally required to disclose adverse health effects and adverse events reported by consumers, although they may do so voluntarily. In addition, cosmetic manufacturers are not required to test their products before they are sold on the market. Under the law, cosmetic products and ingredients do not need FDA premarketing approval, with the exception of color additives. The companies who manufacture the cosmetics are legally responsible for ensuring the safety of their products.

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What Can the FDA Do?

However, the FDA can take action against cosmetic companies and manufacturers who market adulterated products or misbranded products. “Adulteration” refers to violations involving product composition—whether they result from ingredients, contaminants, processing, packaging or shipping and handling. “Misbranded” refers to violations involving improperly labeled or deceptively packaged products.

The proposed bill has strong industry support from lobbying groups and manufacturers. However, similar bills that have been proposed before have not passed. If passed, the bill would mandate that the FDA review five chemicals for safety annually. The first chemicals that would be reviewed would be:

  • propylparaben- a common cosmetic preservative
  • methylene glycol- a formaldehyde-releasing chemical previously used in some hair-straightening treatments
  • two formaldehyde-releasing preservatives
  • and acetate, an ingredient used in men’s hair dye.

These are products many consumers use every single day. As it stands, consumers have no recourse if harmed by a cosmetic product, unlike what is available if harmed by some other defective products. A&G will continue to update information regarding this important bill.