Asbestos Alert: US FDA Proposes New Testing Rules to Keep Cosmetics Safe

Cosmetic companies may soon face stricter requirements to ensure their talc-containing products are free of asbestos, following a newly proposed federal rule by the U.S. Food and Drug Administration (FDA). Announced on December 27, 2024, and mandated by Congress, the proposal aims to reassure consumers about the safety of personal care products such as makeup and baby powder.

This initiative stems from years of litigation against companies like Johnson & Johnson (J&J), alleging links between talc-based products and cancer.

Exploring the Link Between Talc and Cancer:

Talc, a mineral widely used in cosmetics to absorb moisture and enhance texture, is sometimes mined near asbestos deposits. Asbestos, a known carcinogen, can contaminate talc during mining. While concerns about this risk have been recognized for decades, research has provided inconclusive evidence of a direct link between talc and cancer.

FDA testing since 2021 has analyzed over 150 talc-containing cosmetic samples and found no asbestos. However, ongoing concerns prompted Congress to pass legislation in 2023 requiring the FDA to establish industry standards for asbestos testing in talc products.

New Testing Standards:

The FDA's proposed rule introduces rigorous testing protocols to identify asbestos in talc products. It recommends analytical methods such as Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM), which utilize advanced technologies like energy-dispersive spectroscopy and electron diffraction. Manufacturers have the option to submit a certificate of analysis obtained from their talc suppliers.

Dr. Linda Katz, director of the FDA's Office of Cosmetics and Colors, stated, “We have carefully considered the scientific data and policy complexities surrounding asbestos detection in talc products. These proposed testing methods are critical to ensuring consumer safety.”

The rule also mandates that manufacturers maintain compliance records. Products found to contain asbestos, or those that fail to meet testing requirements, will be classified as adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Legal and Industry Implications:

Despite calls from advocacy groups such as the U.S. Public Interest Research Group (PIRG) to ban talc outright, the FDA's proposal stops short of such a measure.

Johnson & Johnson has faced extensive legal battles over allegations that its talc-based baby powders caused ovarian cancer in women who used them for feminine hygiene. The company discontinued the product in North America in 2020 and globally in 2023 but maintains that its products are safe.

To resolve ongoing lawsuits, a J&J subsidiary has proposed an $8 billion settlement, which includes declaring bankruptcy. However, the Justice Department has challenged this plan in court.

Recent Cases of Contamination:

Concerns over asbestos contamination have led to recalls in recent years. For example, the FDA identified asbestos in cosmetics sold by Claire's Stores in 2019, prompting recalls. In October 2024, Dynarex expanded a recall of its baby powder, sold across 35 states and on Amazon, due to possible asbestos contamination.

Next Steps:

The FDA is seeking public comments on the proposed rule, with a 90-day window for submissions after its publication in the Federal Register. Once finalized, the rule aims to enhance consumer safety and industry accountability.

References:

1. U.S. Food and Drug Administration. "FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products." FDA News Release, December 26, 2024. Accessed December 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc.

(Input from various sources)

(Rehash/Sai Sindhuja K/MSM)