Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Each day, cosmetic products are sold to consumers across the U.S. – some to children under the age of 18, still in the formative years of development. These products are used as part of daily beauty and cleansing routines, often times on the skin’s most sensitive areas, like the face, eyelids and lips. That’s why it’s so important that cosmetic products are safe, properly labeled and free of contamination. It’s also why when we hear about reports of contamination, like the 2017 reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers, we’re especially concerned.
Today, we’re providing an update on our assessment of the contaminated Claire’s and Justice products. This includes the release of new independent testing results and an associated safety alert that warns consumers against the use of certain cosmetics sold by Claire’s. We’re also announcing new steps that the FDA is taking, given existing limitations on our cosmetic oversight authority, to better ensure the safety of the cosmetic products men, women and children use every day. Our goal is to help ensure the safety of the products that consumers use and pursue steps that modernize our pursuit of that mission.
The cosmetics industry is undergoing rapid expansion and innovation. These changes help bring new opportunities and choices to consumers. There are now more varieties of cosmetic products available to consumers than ever before. But they can also bring new uncertainty, complexity and risks. And at the same time, the provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) – the law governing the FDA’s oversight of cosmetic products — have not been updated since it was first enacted in 1938. The current law does not require cosmetics to be reviewed and approved by the FDA prior to being sold to American consumers. There are reasons why the FD&C Act doesn’t require prior approval of cosmetics before marketing. Our statute is based on risk, and many cosmetics do not pose the same risks as medical products that require prior approval before they can be lawfully marketed. Our regulatory approach across our broad portfolio is not a one-size-fits-all approach.
But at the same time, when it comes to cosmetics, our authority hasn’t changed in many years even as the industry has undergone rapid evolution. Right now, when it comes to cosmetics, companies and individuals who market these products in the U.S. hold the responsibility for the safety and labeling of their products. This means that ultimately a cosmetic manufacturer can decide if they’d like to test their product for safety and register it with the FDA. To be clear, there are currently no legal requirements for any cosmetic manufacturer marketing products to American consumers to test their products for safety.
Although the FDA doesn’t have pre-market review authority, there are other tools besides the requirement for approval that the FDA uses to ensure the safe marketing of products. In the case of cosmetic products, the FD&C Act imparts the responsibility on us to monitor the cosmetics market and take action to protect consumers, if needed, in the post-market setting. Cosmetics must not be "adulterated" or "misbranded," meaning they must be safe for consumers when used according to directions on the label, or in the customary or expected way, and they must be properly labeled. The FDA’s current work focuses on reviewing scientific literature; reviewing reports of adverse events involving cosmetics that we receive from consumers and health professionals; research; surveillance; education and outreach; and pursuing enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
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