The U.S. Food and Drug Administration issued three final guidances and one draft guidance Tuesday that the agency said would provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
One final guidance addresses the agency’s overall approach for all products that it regulates, while two additional final guidances cover foods and cosmetics. One new draft guidance addresses food for animals.
But two of the consumer groups that sued the FDA in 2012 over its lack of regulation of nanomaterials said that the new FDA guidances won’t protect consumers. The lawsuit asked that: (1) nanomaterials be tested for safety before they’re used in food and cosmetics, (2) products containing nanomaterials be labeled, and (3) products containing nanomaterial be recalled until the new technology is proven to be safe.
"These are mere guidances from FDA and do not offer the substantial regulation we are seeking to ensure nanomaterials are managed safely and transparently,” Kate Colwell, spokeswoman for Friends of the Earth, said.