If you wanted to create a batch of homemade moisturizers and sell them online, you could go ahead and start—no paperwork, pre-market approval process, or registration required, says Dr. Steve Xu, a resident physician in the department of dermatology at Northwestern University Feinberg School of Medicine.
That’s because cosmetics, which fall under the purview of the Food and Drug Administration, are very lightly regulated. While the agency has some labelling requirements, companies can easily avoid listing a product’s ingredients by claiming doing so what give away trade secrets. What’s more, manufacturers don’t have to report health complaints to the FDA.
To identify potentially dangerous products, the agency relies on direct reports of adverse events from consumers. Understandably, these are pretty sparse (In 2014, the FDA opened an investigation into Wen Hair Care products after receiving 127 complaints that it caused hair loss. Unbeknownst to the agency, the company had already received more 21,000 complaints from consumers.)
Xu, along with several colleagues, evaluated the more than 5,000 health-related cosmetic complaints submitted to the FDA between 2004 and 2016. In a new research paper, they outline their findings that, they say, illustrate why the agency should adopt stricter standards to ensure consumers aren’t buying potentially harmful products.
We asked Xu what changes he’d make to the regulatory system, plus why terms like “organic” don’t mean much.
This interview has been edited for length and clarity.
How are cosmetics regulated now?
In 1938, the Federal Food, Drug, and Cosmetic Act was passed. From then on, cosmetics were under the purview of the FDA… and for the past 80 years, unlike with devices and drugs, nothing much has changed. Cosmetic products don’t need FDA approval; they’re largely self-regulated.
So if I wanted to make a skin cream I could just start selling it?
The next day, no problem.
Do you think most people realize how little oversight there is?
Look, I think people understand that a soap brand doesn’t require FDA-approval before getting on the market. But [what is perhaps less understood] is, let’s say a soap caused you to experience an irritation or skin problem, and you tell the company—the company is under no obligation to forward your complaint to the FDA, and the FDA has no legal authority to recall the product.
Are there examples of products that have remained on the market even after a series of health complaints?
Wen Hair Care is a good example. [Founded by celebrity hairstylist Chaz Dean, consumers allege the products resulted in skin irritation and, in some instances, hair loss.] Two and a half years later, we still don’t know what is causing the complaints, and the products are still on market.
I’m not advocating we need clinical trials for every moisturizer…I’m not an alarmist. The message isn’t, ‘cosmetics are unsafe, throw away your shampoos and conditioners.’ But our system is very reactionary. This is problematic, especially for new product classes, such as cell therapy or skin lightening creams, which don’t need approval before entering the market.
What would you like to see happen?
The pendulum needs to shift. There have been multiple attempts to modernize regulations around cosmetics, starting in the 1970s. Maybe this is finally the year: Dianne Feinstein and Susan Collins have introduced a bill to amend the Federal Food, Drug, and Cosmetics Act. It basically says manufacturers would be required to submit complaints to the FDA, provide a complete list of ingredients, and it would allow the FDA to order recalls.
So pretty minimal requirements.
If you compare the US and the EU, it would be a far less stringent approach. The EU bans more than a thousand chemicals—we ban around 10.
I don’t want make it so it sounds like cosmetics are unsafe. It’s a very safe product category, compared with drugs, or even food. But we have to think about how these products are being used—on newborns, on pregnant woman. We haven’t modernized the system in the last 50 years, and in that time, the industry has grown and developed.
Anything else you wish more people realized about cosmetics?
Terms like organic aren’t regulated, which means they have very little meaning. The same thing is true for words like hypoallergenic.
