NAM: Manufacturers Concerned About Flawed FDA Methodology
The Food and Drug Administration is considering a scientifically flawed method for detection of asbestos in talc-containing cosmetics products—a move that could have far-reaching implications across the manufacturing sector.
What’s going on: In December, the FDA published a proposed rule for detecting and identifying asbestos, as required by the Modernization of Cosmetics Regulation Act of 2022. But the proposal is based on unsound science that could limit companies’ ability to utilize talc, a key manufacturing input.
- The overinclusive testing methodology prescribed in the rule is highly likely to misidentify non-asbestos minerals as asbestos. That means that a “positive” test could classify talc as contaminated with asbestos—even if no asbestos is present.
- In May, the FDA held a roundtable discussion on the safety of talc, at which participants discussed the merits of expanding this de facto talc ban beyond cosmetics and to most if not all products and manufacturing processes.
Why the NAM is concerned: Beyond cosmetics, talc is used in a wide variety of industries—including pharmaceuticals, food, plastics, paper, automotives, rubber, roofing, paint, coatings, pottery and ceramics. It is also commonly used on shop floors throughout the industry.
- For many companies, talc substitutions may be inferior or may not exist at all.
- In addition, an FDA-endorsed standard prone to false positives is highly likely to distort other agencies’ asbestos detection testing methods and exposure analysis.
The NAM says: The FDA should withdraw the proposed standard and publish a new rule that contains scientifically sound and accurate testing methods.
- “Manufacturers support the use of sound science,” said NAM Managing Vice President of Policy Charles Crain. “The FDA has the opportunity to repromulgate this flawed rule to provide for accurate, science-based testing that actually protects consumers—rather than a flawed standard that could have far-reaching and costly consequences throughout the manufacturing industry.”