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Situation Report: Cosmetic Safety for Humans in 2022

Shannon Johnson Skin Insights

Authored by Shannon L. Johnson, MSN, NP-C

Cosmetics Defined

Cosmetics are legally defined in the United States (U.S.) 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,” without affecting the body’s structure or functions. Cosmetics include non-prescription skin care, hair care, body care and color cosmetics. Examples are facial cleanser and moisturizer, shampoo and hair spray, shave gel and deodorant, and lipstick and eye shadow. Cosmetics do NOT include pure soap, or anything with an active ingredient listed. Anything with an active ingredient on the label is classified as a drug. Notably, sun protectant is classified as an over-the-counter (OTC) drug.

Cosmetic Safety: Who and How

Cosmetics are regulated in the U.S. by the Food and Drug Administration (FDA). Cosmetic safety law is contained in the Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C). President Franklin Roosevelt signed it in 1938, over 80 years ago. It has been amended numerous times to address food, drug and medical device safety. But in the more than 80 years since its passage, there has been no substantive update on cosmetic regulation.

Concerns

The FFDCA gives FDA authority to inspect the places where cosmetics are made. It also gives FDA authority to seize cosmetics that it finds to be contaminated or adulterated. Importantly, it does NOT give FDA authority to examine the safety of a cosmetic before it is marketed, or force a company to stop selling a cosmetic if safety concerns arise. If FDA believes a cosmetic may be harmful to consumers, it must rely on voluntary cooperation from the cosmetic-maker or pursue action through the court system. In pursuing court action, the burden is on FDA to prove that the cosmetic is harmful, and not on the maker to prove that it is safe.

In effect, there is no meaningful regulatory barrier to launching a cosmetic product. Ingredient and formula safety is not reviewed by FDA before a cosmetic is sold in the U.S. It is considered good practice to test product safety before a cosmetic is first sold for human use, but it is not required. So, for example, if a cosmetic maker skips the step of testing for effective preservation, it is possible that a product could grow bacteria, fungus or mold if contaminated. Or, if the maker of a topical product skips repeated insult patch testing (RIPT), it is possible that the product could cause skin irritation or skin allergy in a significant number of consumers.

Preservative efficacy testing (PET) and RIPT are examples of pre-market tests. Equally important is ongoing post-market surveillance. Ideally each batch of product is tested for contamination before it is released for sale so unintended things like bacteria and mold never market it to the consumer. In the event that consumers do experience a problem (like spoiled product or broken glass), one hopes the cosmetic makers would have a mechanism to record those reports, identify what batch(es) might be affected and trace them to the individuals who purchased them.

Unfortunately, this rigor is not mandated by existing cosmetic safety law. The problems that result are sometimes obvious, such as visible contamination, or rash or skin irritation soon after application. Other times the hazard is more hidden and may appear after a delay or only with prolonged use. In this case it is difficult for the consumer to link the problem to the product. Examples of hidden dangers include ingredients that have the potential to sensitize skin reactions (i.e., cause new or worse reaction over time), disrupt hormones and cause cancer.

Where Things Stand

Numerous attempts at strengthening cosmetic safety in the U.S. have not passed out of committee in Congress. The current attempt is the Personal Care Products Safety Act, which was introduced to the 117th Congress as S.2100 by Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) in June 2021. It is currently in the first stage of the legislative process (referred to the Committee on Health, Education, Labor, and Pensions). Follow its progress here: https://www.congress.gov/bill/117th-congress/senate-bill/2100/text?r=8&s=1. Find your Members of Congress here to let them know what you want them to do: https://www.congress.gov/members/find-your-member.

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