FDA Cosmetics Approval Process

The US Food and Drug Administration (FDA) does not approve cosmetics, but does have regulatory authority2. However, the line between cosmetics and drugs, as defined by the agency, can get blurry. A cosmetic is anything we smear, rub or otherwise apply to our bodies to clean ourselves or to change our appearance. A drug is a substance consumed in order to treat or mitigate a disease or condition3. Some cosmetics can be classified as drugs due to their intended use. For example, a substance marketed as an anti-aging moisturizer is a cosmetic, but if it claims to “boost collagen production” or “encourage growth of new skin cells” then you’re heading into drug territory.

The largest area of overlap between drugs and cosmetics is in products like anti-dandruff shampoo, sunscreens, and antiperspirants. These products fall into the category of over-the-counter (OTC) drugs, and as long as they adhere to predefined strengths, uses and applications, require no special approvals.

As with many regulatory bodies, the instigating event that led to the formation of the FDA, as we know now it, was a tragic one.
The Federal Food, Drug and Cosmetic Act was instituted in 1938 after more than 100 people, many of them children, died from taking Elixir Sulfanilamide, a liquid sulfa mixture marketed by SE Massengill Company6. The elixir contained diethylene glycol (DEG), a liquid used in brake fluid and wallpaper stripper. The FDA, which had been established in 1906, worked quickly with local pharmacists, doctors and chemists to identify the source of the poisonings. The chemist responsible for the concoction committed suicide awaiting trial; Massengill paid a fine and the FDCA-giving authority to the FDA to regulate drugs-was quickly passed by Congress.

Which isn’t to say the FDA is leaving consumers completely high and dry when it comes to cosmetic products; the Federal Food, Drug and Cosmetic Act  addresses concerns about adulterated or misbranded cosmetics2. Manufacturers bear the burden of making sure their product is safe when used as directed; if a product is found to created adverse reactions there are some steps the FDA can take.

For example, the agency may contact the manufacturer, issue a warning letter about ingredients missing from the product label, including colors or dyes that fall under FDA regulation, or branding that infers the product is designed to treat a medical condition (which would make it a drug.)  While the FDA cannot enforce a recall, it does have the ability to request a company to issue a public statement and recall a product. Failing the voluntary recall, the FDA can issue a public statement classifying the product as a potential hazard.

The agency publishes a weekly enforcement report1 which includes all areas under FDA purview and their classification (I, II, or III, with III indicating “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” A quick review of recent reports shows the bulk of the recalls consist of biologicals (mostly blood products), devices (surgical hardware and appliances) and drugs. A majority of the classifications are level II, “product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The cosmetic items listed were lotions, face masks, cleaning wipes, eyeliner and tattoo ink-all recalled because of high levels of microbial or bacterial contamination.

Other organizations have stepped into the void of proactively evaluating cosmetics; one example is the Skindeep Database, a project of the nonprofit Environmental Working Group5 (EWG). Their mobile app and website rates soaps and cosmetics on a scale of environmental friendliness and indicates if the product contains known hormone disruptors, suspected or known carcinogens, and other potential hazards that may slip through the FDA’s wide net.

Resources

1. Enforcement report-Recall Information Search. US Food and Drug Administration. http://www.accessdata.fda.gov/scripts/ires/index.cfm#tabNav_advancedSearch.
2. FDA authority over cosmetics: How cosmetics are not FDA-Approved, but are FDA-Regulated. US Food and Drug Administration. http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm.
3. Is it a cosmetic, a drug, or Both? (or is it soap?). US Food and Drug Administration. http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm.
4. "Regulatory Actions; Personal Care Products Council CEO & President Pamela G. Bailey Testifies on FDA Cosmetic Regulation before U.S. House Committee on Energy and Commerce." Medical Letter on the CDC & FDA (2008): 110. ProQuest. Web. http://search.proquest.com.ezproxy.rit.edu/docview/211457177?pq-origsite=summon
5. Skin Deep® cosmetics database. Environmental Working Group. http://www.ewg.org/skindeep/  
6. Sulfanilamide disaster. US Food and Drug Administration. http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm.