The U.S. Food and Drug Administration issued three final guidances and one draft guidance Tuesday that the agency said would provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.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 One new draft guidance addresses food for animals.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.
“The FDA is still giving the responsibility for determining if nanomaterials are safe to companies that want to use them,” Lovera said.
The agency suggests that companies may want to consider registering nanomaterials with the FDA, but the process for doing so is the Generally Regarded as Safe designation. The GRAS determination is a dated and inadequate system that isn’t good enough to regulate traditional food additives, let along new technologies such as nanomaterials, she said.
In addition, the FDA isn’t requiring labeling for products that contain nanomaterials, so consumers won’t have the necessary information if they wish to avoid them, Lovera said.
“So overall, no real progress [has been made] in these new documents,” she said.
Nanotechnology is an emerging technology that allows scientists to create materials on a scale measured in nanometers – particles so small that they can’t be seen with a regular microscope.
“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.”
The three final guidance documents reflect the FDA’s current thinking on nanotechnology after considering public comments received on the drafts of the documents.
The FDA isn’t making a judgment that nanotechnology is safe or harmful, and the agency will continue to consider the specific characteristics of individual products, Hamburg said.
All four guidance documents encourage manufacturers to consult with the FDA before taking their products to market.
“Consultations with the FDA early in the product development process help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact, and/or regulatory status of the product,” Hamburg said.
The guidances are:
- Considering whether nanotechnology is being used. The guidance outlines considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology.
- Evaluating the safety of the use of nanomaterials in cosmetics. The guidance describes the FDA’s current thinking on the safety assessment of nanomaterials used in cosmetic products and encourages manufacturers to consult with the FDA on test methods and data needed to prove a product’s safety.
- Considering the effects of manufacturing changes on the safety and regulatory status of food ingredients, including color additives, and items that come in contact with food. The guidance alerts manufacturers to the impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also addresses manufacturing process changes for a food substance already in the market.
- Evaluating the use of nanomaterials in animal food. This draft guidance addresses issues related to the use of nanotechnology in food for animals. The FDA is accepting public comments on this draft guidance until Sept. 10.
The FDA will continue its research on nanotechnology and has invested in a nanotechnology regulatory science program, Hamburg said.
She said additional guidance for industry will be developed as needed.