FDA Proposes New Rule to Ensure Talc-Based Products are Asbestos-Free
Cosmetic companies would have to take extra steps to ensure that any products containing talc are free of asbestos under a federal rule proposed Thursday.
Background
The proposal from the Food and Drug Administration and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder, and other personal care products.
History of Concerns
It follows years of lawsuits against Johnson & Johnson and other companies alleging links between talc-based baby powder and cancer.
Research Findings
Despite the lawsuits, research has found mixed evidence of a potential link between cancer and talc, although the possibility has been recognized for decades because of how it is mined.
Talc and Asbestos
Talc is a mineral used to absorb moisture or improve the texture, feel, and color of cosmetics. It is mined from underground deposits that are sometimes located near the toxic mineral asbestos. The risk of cross-contamination has long been recognized by cosmetic companies.
Recent Testing
But recent FDA-sponsored testing hasn’t uncovered any safety issues. Since 2021, laboratory analysis of more than 150 cosmetic samples has come back negative for asbestos, according to the FDA.
New Industry Standards
Still, concerns about the risk prompted Congress to pass a 2023 law requiring the FDA to release new industry standards for asbestos testing.
FDA Statement
Dr. Linda Katz, the director of the FDA’s Office of Cosmetics and Colors, said in a statement that the agency has “carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products.”
J&J Lawsuits
The long-running litigation against J&J alleges that the company’s talc baby powder caused women to develop ovarian cancer, when used for feminine hygiene.
Settlement Proposal
A J&J subsidiary has proposed paying roughly $8 billion to settle tens of thousands of lawsuits. As part of the deal, the subsidiary would declare bankruptcy, although that proposal has been challenged in court by the Justice Department.
Cancer Risk
Determining the root cause of cancer is difficult, especially in cases of ovarian cancer, which is a relatively rare form of the disease. Even large studies in thousands of women might not gather enough data to show a clear connection or definitively rule one out. The American Cancer Society says that, if there is an increased risk of cancer due to talc, “it is likely to be very small.”
Conclusion
The proposed rule aims to ensure the safety of talc-based products by requiring cosmetic companies to take extra steps to detect and identify asbestos. While the scientific evidence is mixed, the FDA believes that the proposed testing techniques are appropriate methods to detect asbestos and help ensure the safety of talc-containing cosmetic products.
FAQs
Q: What is talc?
A: Talc is a mineral used to absorb moisture or improve the texture, feel, and color of cosmetics.
Q: Is there a link between talc and cancer?
A: Research has found mixed evidence of a potential link between cancer and talc, although the possibility has been recognized for decades because of how it is mined.
Q: What is the FDA proposing to do?
A: The FDA is proposing new industry standards for asbestos testing to ensure that talc-based products are free of asbestos.
Q: What is the current status of J&J lawsuits?
A: A J&J subsidiary has proposed paying roughly $8 billion to settle tens of thousands of lawsuits, although that proposal has been challenged in court by the Justice Department.
Q: Is there a risk of cross-contamination between talc and asbestos?
A: Yes, the risk of cross-contamination has long been recognized by cosmetic companies, as talc is often mined near asbestos deposits.
