FDA Proposes Standardized Testing for Asbestos in Talc-Based Cosmetics

In light of increasing concerns about the potential harms of asbestos exposure through cosmetics, federal regulators have proposed a new rule to standardize testing for the toxic substance in all talcum powder-based products.

The U.S. Food and Drug Administration (FDA) issued a press release on December 26, announcing a proposed asbestos testing rule for talc-containing cosmetics, with the goal being to protect consumers from unnecessary asbestos exposure.

It has been known for about a century that asbestos exposure can cause a number of serious health conditions, including lung cancer, asbestosis and mesothelioma, although information about the risk was not widely publicized until about 1964. Most modern, first-world countries banned asbestos use in its entirety decades ago. However, the United States continued to allow some limited forms of asbestos to be used until this year.

In addition, some asbestos risks have been detected in places where asbestos should not be, such as in talcum powder cosmetic products, which has led to tens of thousands of talcum powder cancer lawsuits in recent years.

Johnson & Johnson has been fighting  Baby Powder lawsuits and Shower-to-Shower lawsuits for nearly a decade, and has been hit with several massive damage awards, where juries found that the manufacturer knew or should have known about the risks associated with adult women applying the talc-based powder around the genitals for decades. However, rather than warning about the risk, Johnson & Johnson continued to promote Baby Powder and Shower-to-Shower for use by adult women.

According to the agency, the FDA’s newly proposed rule would make it mandatory that talc-containing cosmetic products be tested for asbestos using both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TRM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).

The agency has determined these tests are the most accurate ways of determining whether talc contains asbestos, and the proposed rule would require that manufacturers maintain accurate records of their compliance with the new rule.

The rule would also mean that cosmetic products not properly tested would be considered adulterated, meaning they are being illegally sold.

“For many years the FDA has been sampling and testing talc-containing cosmetics for asbestos as well as working with our federal partners on efforts to reduce consumers’ risk of exposure to asbestos, a known human carcinogen, from contaminated talc-containing cosmetic products,” Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, said in the press release. “We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products. We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products.”

The FDA is requesting public comment on the proposed rule, which the agency will accept for 90 days after the rule is published in the Federal Register.

Johnson & Johnson Talcum Powder Cancer Lawsuits

The proposed rule comes as Johnson & Johnson attempts to resolve tens of thousands of talcum powder cancer lawsuits through a controversial bankruptcy technique called the “Texas Two-Step.”

In September, as part of an $8 billion talcum powder lawsuit settlement offer, Johnson & Johnson created a new subsidiary known as Red River Talc LLC, and transferred all liabilities it faced for failing to warn about the talcum powder cancer risks to this new entity, which then filed for Chapter 11 protection in U.S. Bankruptcy Court for the Southern District of Texas.

This is Johnson & Johnson’s third attempt at forcing the talcum powder cancer litigation through bankruptcy, with two prior filings rejected by the courts. However, those efforts did successfully delay additional cases from going to trial.

The case has been assigned to U.S. Bankruptcy Judge Christopher Lopez in Texas. On October 30, Judge Lopez announced that he will hold a consolidated hearing on January 27, at which point he will hear objections to the plan.

Those objections include allegations that Johnson & Johnson’s purported support by 75% of claimants for the bankruptcy deal is not legitimate, as well as claims by the U.S. Department of Justice that this latest filing was made “in bad faith,” as part of an attempt to abuse the bankruptcy system.