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FDA issues draft guidance on nanotech in cosmetics

Washington — The Food and Drug Administration has issued a new draft guidance encouraging cosmetics manufacturers to subject products containing nanomaterials to additional testing.

The engineered submicroscopic particles are used in skin moisturizers, mineral makeup and sunscreen, among other cosmetics. The new guidance doesn’t require additional testing for products containing such materials, but suggests that standard testing may need to be modified, or new testing methods developed to assess the safety of the particles, according to the Associated Press.

An FDA statement says the agency does not classify nanotechnology as inherently unsafe, but notes materials at such a small scale can raise different concerns than more conventional products.

“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”

While the FDA normally doesn’t require premarket approval for cosmetics, manufacturers are responsible for the safety and proper labeling of products. This includes all cosmetics, not just those containing nanomaterials.

The guidance was released along with a draft guidance about the use of nanomaterials in food packaging. Regulators may require food companies to provide additional data establishing the safety of these particles in food packaging.

Both guidances encourage manufacturers to consult with the FDA before marking their products.

The FDA will accept comments on both proposals for 90 days.

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