When you wash your hair, clean or moisturize your skin, polish your nails, or put on makeup, deodorant or sunscreen, do you ever think about whether the product you’re using may do more harm than good?
Maybe you should. Thanks to a lack of federal regulations, the watchword for consumers of cosmetics and personal care products should be caveat emptor: Let the buyer beware.
To be sure, these products are not nearly as worrisome as drugs, which require extensive testing and premarket approval by the Food and Drug Administration. Still, disasters can and sometimes do occur from the use of cosmetics and personal care products, and the government is powerless to act until a slew of consumer complaints raise a red flag about a product.
In a recent editorial in JAMA Internal Medicine, Dr. Robert M. Califf, who served as F.D.A. chief under President Obama, noted, “The cosmetic industry remains largely self-regulated. History has repeatedly shown that when there is insufficient regulatory oversight, a few unscrupulous people or companies will exploit the vulnerable public for profit.”
Even when a hazard comes to light, a product can remain on the market for years until negotiations make their way through the legal system or the company decides to halt sales. (Although the F.D.A. finally banned antibacterial chemicals like triclosan from soaps, triclosan is still in toothpastes and other consumer products.)
A current case is a classic example. The F.D.A. normally receives about 300 to 400 complaints a year about bad reactions to cosmetics and personal care products, all of which are sold over-the-counter without prior government scrutiny. When in 2013 the agency received 127 reports of adverse effects from a single line of hair-care products called WEN, it discovered that the manufacturer, Chaz Dean, Inc., had been sitting on more than 21,000 complaints of hair loss and scalp damage associated with the products’ use.
A class-action lawsuit filed by more than 200 women against the company and its infomercial producer Guthy-Renker was settled last year for $26.3 million. Yet the company claims that WEN hair care products are “totally safe” and continues to sell them.
Unlike drugs, cosmetics can be sold based solely on manufacturers’ tests (or no tests at all) and claims for effectiveness and safety. Even the ingredients don’t have to be filed with the government. (Only color additives require premarket approval.)
“The F.D.A. must wait for clues to accumulate from voluntary reports suggesting that a product may not be as completely safe as presumed,” Dr. Califf, a cardiologist, health policy expert and vice chancellor at Duke University School of Medicine, wrote.
Asked in an interview whether more can be done to protect the public, he said, “It’s highly unlikely in the current administration. There’s a tiny work force at the F.D.A. to deal with an enormous industry that’s currently self-policing. Voluntary reporting of adverse events linked to cosmetics and personal care products is a lot better than nothing, but it’s way inadequate for the job. There’s no legal requirement for manufacturers to forward reports of adverse events to the F.D.A.”
(Only manufacturers of drugs and medical devices are required to submit reports of hazards associated with their products to the federal agency.)
The Federal Food, Drug and Cosmetic Act defines 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.”