On March 5, 2019, the FDA provided an update on its assessment of contaminated Claire’s and Justice products. The FDA released new independent testing results that confirmed the presence of asbestos in product samples collected from Claire’s and Justice. Additionally, the FDA issued a safety alert that warned consumers against the use of certain cosmetics sold by Claire’s. The FDA also announced new steps that the FDA would be taking, given existing limitations on the FDA’s cosmetic oversight authority, to better ensure the safety of cosmetic products.
The provisions in the Federal Food, Drug, and Cosmetic Act (FDCA) – 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. The FDCA 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.
Although the FDA does not 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 FDCA imparts the responsibility on the FDA 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 the FDA receives 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.
The FDA routinely monitors the market for cosmetic products that may pose a public health risk. This is how the FDA, in 2017, first became aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On September 5, 2017, Justice voluntarily recalled its Just Shine Shimmer Powder and seven additional cosmetic products. On December 22, 2017, Claire’s removed from its stores the following products: Ultimate Mega Make Up Set, Metallic Hot Pink Glitter 48-Piece Makeup Set, Bedazzled Rainbow Heart Makeup Set, Rainbow Bedazzled Star Make Up Set, Rainbow Glitter Heart Shaped Makeup Set, Mint Glitter Make Up Set, Rainbow Bedazzled Rectangle Make Up Set, and Pink Glitter Palette with Eyeshadow & Lip Gloss.
Because the 2017 testing was done by third-party laboratories, the FDA believed it was important to scientifically confirm that these reports were accurate. After Claire’s withdrew and Justice recalled suspect products from the market, the FDA began the process of conducting independent tests to determine if some of these products did in fact contain asbestos. In late February of 2019, the FDA received the results of this testing initiative.
Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice. All suspect Justice products, including the one testing positive for asbestos, were previously recalled from the market in 2017.
The FDA requested that Claire’s recall the products because they should not be used by consumers. Claire’s refused to comply with the FDA’s request, and the FDA does not have authority to mandate a recall. Consequently, the FDA issued a Safety Alert warning consumers to not use three of Claire’s products: Claire’s Eye Shadows – Batch No/Lot No: 08/17; Claire’s Compact Powder – Batch No/Lot No: 07/15; and, Claire’s Contour Palette – Batch No/Lot No: 04/17 because they tested positive for asbestos.
The FDA called upon the cosmetic industry to take important new steps. First, the FDA asked cosmetic manufacturers to voluntarily provide the FDA information about what procedures the cosmetic manufacturers use to ensure their cosmetics are safe and, in particular, about how they ensure that talc used in any cosmetic product is free from asbestos. The FDA planned to investigate how manufacturers source talc with appropriate traceability, and whether they test raw talc and/or their finished products. The FDA asked for cosmetic manufacturers to provide the FDA with information about how many cosmetics products contain talc and whether manufacturers have received adverse event reports associated with talc-containing products. The FDA hoped this information would help the FDA better identify specific cosmetic products and raw ingredient suppliers that may be more likely to be contaminated.
Second, although the FDCA does not require cosmetic products to be registered with the FDA, the FDA asked cosmetic manufacturers to voluntarily register their products and list ingredients, including talc, used in their products via the FDA’s Voluntary Cosmetic Registration Program (VCRP). This program provides a mechanism for cosmetic manufacturers, distributors, and packers to voluntarily file information on their products that are currently being marketed to U.S. consumers and to register their manufacturing and/or packaging facility locations.
Third, the FDA asked cosmetic manufacturers to proactively report adverse events involving cosmetic products to the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System. Although this is not required by current law, this reporting is an important component of responsible marketing and safe oversight of these products.
Separately, the FDA formed an interagency working group with representatives from other federal agencies to propose draft standards to improve analytical consistency for talc testing, which will be the subject of an upcoming public forum.
The FDA planned to work with Congress to modernize the outdated regulatory framework that the FDA has been operating under for more than 80 years when it comes to cosmetics. To improve consumer safety, a more modern approach could include tools that are tailored for cosmetics, including appropriate frameworks for registration and listing of products and their ingredients, good manufacturing practice regulations, company reporting of adverse events, access to records (including consumer complaints) during routine or for-cause inspections, mandatory recalls, disclosure of known cosmetic allergens on a product’s label, and ingredient review.
See the FDA Announcement
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