Last week the prestigious Journal of American Medical Association, or JAMA, published two important articles online about personal care products – one finding higher than average reports of adverse reactions to baby products and an editorial calling for greater regulation of personal care products.
The study analyzing adverse events, or bad reactions to cosmetics, looked at reports received by the Food and Drug Administration between 2004 and 2016. The authors found that 5,144 adverse events were reported during that time frame, with baby products having higher than average reports.
As the editorial points out, adverse event reports submitted to the FDA are entirely voluntary, giving a severely incomplete picture of real risks to public health, especially with regard to children’s health. In fact, cosmetic companies don’t even have to inform the FDA what products they are making or where they make them. Because there is no legal requirement for the personal care product industry to report adverse reactions to their products, the FDA is often unaware of an issue until the problem becomes significant or it gets information from other sources.
For example, the FDA is sometimes tipped off to look for a problem by nations with more robust regulatory systems, which are able to identify and respond to public health issues more quickly. When thousands of people suffered from hair loss as a result of using Wen hair products, the FDA received just 127 adverse event reports, only later realizing that the company responsible had received more than 21,000 complaints. Even when the FDA becomes aware of a serious problem like Wen’s products, it has very limited authority to actually do anything about it. The agency can’t even issue a mandatory recall.
The JAMA editorial writers recognize that the FDA’s limited authority presents a public health risk and should be reformed. They note that “any substance applied to or in the body can cause harm, given the right circumstances." They point out that the office responsible for regulating personal care products at the FDA is vastly underresourced and call for Congress to provide adequate funding. And they also call for a system of mandatory registration for all personal care products marketed in the U.S. so that the FDA can better understand the universe of products to which consumers are exposed.
Bipartisan legislation recently introduced by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, would create mandatory registration of products and facilities, provide new FDA funding through industry fees, and give the FDA several other common-sense tools to protect the public from risks of personal care products.