Most people assume that the Food and Drug Administration oversees cosmetics with the same diligence it uses for over-the-counter drugs. In reality, the cosmetic industry is largely unmonitored by the FDA.
Even when consumers report adverse reactions to cosmetics, it is not clear that the FDA will investigate. The voluntary reports that are submitted to the agency did not used to be public.
Peeking into the FDA’s Database of Bad Reactions to Cosmetics:
Now, however, researchers can review these data. An article in JAMA Internal Medicine reveals that the number of reports doubled between 2015 and 2016.
Trouble with WEN:
Much of this consisted of reports of rash, skin irritation and hair loss linked to a hair conditioner called WEN. When the FDA announced an investigation of the product in 2014, it asked the public to submit its reports directly to the agency rather than to the manufacturer. Although FDA had received 127 complaints about the product at that time, it discovered that the manufacturer had more than 21,000 on record that it had not shared. Inviting the public to report problems to the FDA brought many more cases to light.
How Should FDA Regulate Cosmetics?
The researchers writing in JAMA Internal Medicine suggest,
“The lack of high-quality data leads to reactionary responses by the FDA subject to consumer pressure as evidenced by the WEN conditioners controversy.”
In an accompanying editorial, former FDA commissioner Robert Califf, MD, and his co-authors call for more resources and legislation so that the FDA can make sure that cosmetics are safe. In fact, they point out,
“For cosmetics–and for dietary supplements–the FDA’s oversight authority remains stuck at the levels established in 1938, nearly 80 years ago.”
That clearly is not acceptable for today’s consumers, especially when questions have been raised about possible long-term harm.
