U.S. health regulators stated consumer products companies that use nanotechnology will need to provide additional testing data to ensure the products are safe.
The Food and Drug Administration issued two draft guidances for the use of nanotechnology in food and cosmetics industries. Specifically, the draft guidance suggests the FDA may require food companies to prove the safety of any packaging using nanotechnology, according to reports.
Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status, according to the FDA.
Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers—particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.
"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."
The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:
- affect the identity of the food substance;
- affect the safety of the use of the food substance;
- affect the regulatory status of the use of the food substance; or
- warrant a regulatory submission to FDA.
In a separate guidance, the FDA laid out suggestions for the use of nanotechnology in cosmetics. Nanoparticles are used in some skin moisturizers and other cosmetics.
The FDA will take comments on both proposals for 90 days. There is no deadline for finalizing the documents.