Legislation Will Empower FDA to Address Asbestos in Makeup

Legislation & Litigation

Legislation aimed at providing the U.S. Food and Drug Administration with more oversight of the cosmetics industry is one step closer to being implemented. The FDA recently issued a draft guidance document as part of the Modernization of Cosmetics Regulation Act of 2022, also called MoCRA, highlighting key changes. 

Among the industry changes include new FDA regulations that will standardize testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Poor regulation involving cosmetic-grade talcum powder has allowed asbestos in makeup for decades.  

New Federal Regulations Set for Asbestos in Makeup

Talc is a popular ingredient in makeup and creates a soft, silky texture. It has a documented history of asbestos contamination. The two minerals are found close together in the earth and when talc is mined asbestos may be present. 

“What we will see is that some companies will stop using talc altogether, other companies will not use contaminated talc and source their talc better,” Melanie Benesh, vice president of government affairs at the Environmental Working Group, told Asbestos.com. “This is a really important step forward that will give the consumer more information and put the FDA in a better position to ensure cosmetics are safe.”

While studies have discovered asbestos in adult makeup, it has also found asbestos in makeup marketed and sold to children. Long-term exposure to asbestos through talcum powder is known to cause mesothelioma and ovarian cancer. 

As recently as November 2020, a study by the Environmental Working Group found that 14% of talc-containing makeup tested positive for asbestos. That can pose serious health risks for consumers, including cancer, as a result of asbestos exposure.

MoCRA Updates Act Issued in 1938

MoCRA is the most notable broadening of the FDA’s jurisdiction to regulate cosmetics since the Federal Food, Drug and Cosmetic Act was passed in 1938. Before MoCRA the FDA did not require mandatory testing of talc supplies.

FD&C regulates and sets standards for food, drugs, medical devices and cosmetics and was enacted to ensure the safety, effectiveness and accurate labeling of these types of products. The FDA develops regulations based on the laws set forth by the FD&C Act. 

“This new law will help ensure the safety of cosmetic products many consumers use daily,” the FDA wrote in a statement.

MoCRA will give new authority to the FDA to:
  • Access records when certain conditions are met. The FDA can access and copy certain information related to a cosmetic product, including safety records.
  • Issue a mandatory recall. If the agency determines the cosmetic is adulterated or misbranded, or if using the cosmetic will cause serious adverse health consequences or even death, the FDA can issue a mandatory recall.
It also establishes new requirements for the cosmetics industry, including: 
  • Adverse Event Reporting: This reporting is mandatory within 15 business days of the adverse event. The FDA will also have access to adverse event reports during an inspection. The process for submitting mandatory adverse events for cosmetics is being developed.
  • Facilities: Manufacturers and processors must now register their facilities with the FDA and renew registration every two years. A facility registration may be suspended if the FDA determines products made or processed there could cause adverse health consequences.
  • Ingredients: Cosmetic products must be listed with the FDA and include a list of ingredients updated annually. 
  • Safety: Safety substantiation is required to maintain records supporting the safety and substantiation of cosmetic products. Data used to support the safety substantiation must be derived from scientifically robust methods.

MoCRA also requires the industry to comply with FDA regulations for good manufacturing practices, fragrance allergen labeling and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

Many of the MoCRA provisions have one-year deadlines and are expected to take effect in December 2023. There are exemptions to MoCRA for certain small businesses.

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