Cosmetic Regulation in the U.S.: Is the FDA doing enough?

The Food and Drug Administration (FDA) has had authority over cosmetics since the passing of the Food, Drug, and Cosmetic Act (FDCA) in 1938. However, this authority is based only in regulatory power, not approval power. The FDCA does not require cosmetics to acquire pre-market approval, except for cosmetics that have color additives like medical devices and drugs; instead, the FDA uses post-market regulation to bring formal or informal proceedings against a product.The FDA’s authority over the cosmetic industry, which generated approximately $84 billion in revenue in 2016, is substantially different than any other industry area the Agency regulates. 

The FDCA defines cosmetics as any product that is “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.” This includes the obvious, such as moisturizers and facial makeup, but also the nonobvious, such as deodorant and permanent hair waves.  Under this definition, the category of cosmetics encompasses things that both women and men use on a daily basis.  

So how does FDA regulate cosmetics? The FDCA prohibits the marketing of cosmetics that have been adulterated or misbranded. Adulteration address violations involving product composition whereas misbranding addresses improperly labeled or deceptively packaged products. However, the main issue with cosmetics is safety. The FDA states that “companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products,” however “[no] FDA regulation require specific tests to demonstrate the safety of individual products or ingredients.” Companies can use “whatever testing necessary” to guarantee safety. Companies can rely upon already available test data on individual ingredients and similar product formulations or perform their own test for additional information. Even if companies conduct thorough safety testing, “the law also does not require cosmetic companies to share their safety information with FDA.” 

An optimistic approach to FDA regulation would require consumers to fully believe that cosmetic companies conduct thorough safety testing. Since a company’s reputation is on the line, testing for safety is, or should be, a company’s top priority. That is why some dermatologists believe that cosmetics are already safe and that more regulation would be unnecessary. Some also argue that stricter regulation could stifle innovation. Every year there is a new ingredient craze that rocks the cosmetic world.  With stricter regulations, these new ingredients would have to pass through extensive testing which could disincentivize innovation, lead to poorer products, and potentially increase costs. 

Since the industry self-polices, the FDA has to rely on direct reports and complaints from consumers before it can act. For example, in 2014 the FDA launched an investigation into Wen Hair Care after it received about 1,400 complaints about adverse side effects of the hair care products, like hair loss and balding. During its investigation, the FDA learned that Wen Hair Care actually received over 20,000 complaints from consumers before FDA was alerted. Under the FDCA, the FDA could only go after the Wen Hair Care if the products were determined to be adulterated or misbranded. However, if adulterations or misbranding is not the issue, then what can the FDA do? Short of seizing the products to keep them off the market, nothing. 

Current cosmetic regulation might be changing in the near future, though. There are more and more consumers that are looking for health-conscious and clean cosmetic products. Congress has also made a push toward increasing cosmetic safety. In 2017, Senators Dianne Feinstein and Susan Collins introduced a bipartisan proposal that included mandatory reporting and ingredient review of all cosmetics. Also, in 2018, Congresswoman Jan Schakowsky introduced a bill that “…calls for the full disclosure of all ingredients included in beauty and personal care products including fragrances.” While these bills are stirring around in Congress, major cosmetic brands like L’Oréal and Unilever, as well as celebrities like Kourtney Kardashian offer their support for stronger regulation.

 In 2018, Rep.Frank Pallone stated that “[w]hile all other product categories regulated by the [FDA] have been updated to keep pace with innovation and consumer expectations, the laws for cosmetics have been left untouched for nearly 80 years.” Maybe it is time for a change.