FDA Releases Food, Cosmetic Nanotechnology Guidances for Public Comment

WASHINGTON — The Food & Drug Administration (FDA) on April 20 released two new guidance documents for public comment outlining agency policy for the use of nanotechnology in food ingredients and packaging and the use of nanotechnology in cosmetic products. Both guidance documents, which contain non-binding recommendations, will be published in the Federal Register and the agency will accept comment on them for 90 days from publication.

In an FDA fact sheet, the agency says the food guidance “alerts manufacturers to the potential impact of any significant manufacturing process change, including those involving nanotechnology, on the safety and regulatory status of food substances.”

Factors for manufacturers to consider for food products already on the market include whether the change: “affects the identity of the food substance; affects the safety of the use of the food substance; affects the regulatory status of the use of the food substance; and warrants a regulatory submission to FDA,” according to the fact sheet.

The second document lays out the agency’s thinking on conducting safety assessments for cosmetic products, noting that cosmetics with nanomaterials are subject to the same requirements as other products. “In general, the processes currently in use for assessing safety are appropriate for cosmetics containing nanomaterials,” FDA says in its announcement. “However, data needs and testing methods should be evaluated in light of the properties or functions that may be exhibited by nanomaterials used in cosmetic products.”

A PDF of the food guidance can be found here and a PDF of the cosmetics guidance can be found here.