The FDA Doesn’t Actually Have The Power To REcall

Last month, the Food and Drug Administration announced that it would be investigating claims from consumers that the “cleansing conditioner” Wen, purportedly developed by celebrity hairstylist Chaz Dean, had caused scalp irritation and even made some users’ hair fell out. The FDA looked into the situation after receiving 127 complaints about the product, but didn’t know that the marketer, Proactiv maker Guthy-Renker, had received more than 21,000 complaints about the product that it wasn’t obligated to report to the FDA.

The manufacturers of medicines and medical products must send any adverse event reports they receive on to the FDA, but cosmetics aren’t as tightly regulated. The New York Times explains that a customer could report a serious injury or even a death that may be linked to a cosmetic product, and companies are under no obligation to report it to the government.

The FDA does have the power to recall products that are found to either be mislabeled or contaminated. If the product as labeled and intended causes problems for some users, there isn’t anything that the government can do.

There have been efforts to change this law in the past, and different types of cosmetic companies have separate lobbying organizations and favor different levels of regulation. Big companies like Estée Lauder, Procter & Gamble, and Johnson & Johnson favor a version that would require companies to pass adverse event reports on to the FDA, and would also give the FDA the power to recall products that are harmful.

Smaller companies, led by Mary Kay, prefer a version that includes the adverse event reporting, but does not empower the FDA to recall products that have been proven to harm consumers. It happens that the less strict bill’s sponsor is Rep. Pete Sessions, whose district in Texas is near the headquarters of Mary Kay, and who has received campaign contributions from Mary Kay employees and other industry executives.

Cosmetics Industry Splinters Over Legislation Aimed at Unsafe Products [New York Times]

by Laura Northrup via Consumerist