FDA Issues Draft Food Guidance with Information on Nanotechnology Applications

The Food and Drug Administration (FDA) has issued draft guidance that, in part, addresses the use of nanotechnology in food processing. Among other matters, “FDA considers food manufacturing processes that involve nanotechnology in the same manner as any other food manufacturing technology,” although the agency also apparently recognizes that “nanotechnology and other emerging technologies may introduce issues that warrant additional or different evaluation during a safety assessment of a food substance. For example, so-called nano engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”

Accordingly, FDA states, “When a food substance is manufactured to include a particle size distribution shifted more fully into the nanometer range, safety assessments should be based on data relevant to the nanometer version of the food substance. Where nano engineered food substances have new properties, additional or different testing methods may be necessary to determine the safety of the food substance. Thus, the agency recommends the use of safety assessments “as rigorous as possible” and “based on data relevant to the version of the food substance intended for use.” Still, the agency observes, “[a]t this time, we are not aware of any food ingredient or FCS [food contact substance] intentionally engineered on the nanometer scale for which there are generally available safety data sufficient to serve as the foundation for a determination that the use of a food ingredient or FCS is GRAS [generally recognized as safe].” To be considered in the final guidance, public comments must be submitted within 90 days after publication in the Federal Register. See FDA News Release, April 20, 2012.