Nanotech Roundup: Foods v. Drugs, the EC Definition, and NNI’s EHS Research StrategyOctober 30, 2011
By Ricardo Carvajal –
NIH and USDA announced a joint workshop on Using Nanotechnology To Improve Nutrition Through Enhanced Bioavailability and Efficacy. Among the goals of the workshop are to “identify knowledge gaps in the use of nutrients (and bioactive food components) for disease prevention,” and to “catalyze collaborations and stimulate ideas for diet and disease prevention research.” Note to would-be workshop participants: beware of FDC Act section 201 (g), which defines “drug” to include articles intended to prevent disease, and section 301(ll), which prohibits the addition of a “drug” to food.
The European Commission adopted a recommendation to define “nanomaterials” as “a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm – 100 nm." According to a press release issued by the EC, “Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances.” Thus, the definition is intended to be used “for all regulatory purposes.” However, the use of other “nano” terms for specific sectors, such as pharmaceuticals, is not precluded. As we noted in a prior posting, FDA has tentatively adopted a working definition of nanotechnology. That definition is broader than the EC’s definition, in that it is not as firmly anchored to the 1-100nm criterion.
The National Nanotechnology Initiative updated its Environmental, Health, and Safety ("EHS") Research Strategy, which is intended to help Federal agencies “develop nanotechnology risk assessments that inform risk management and regulatory decisions.” As an example of EHS research, the document cites research conducted in part by FDA which determined that intact skin serves as a barrier to sunscreens that contain nanomaterials. FDA reportedly allocated 7.3 million dollars for EHS research in FY 2010, the second year for which FDA has allocated EHS funding. While FDA continues to develop its nanotechnology-related infrastructure and expertise, the agency is also said to be “leading an effort to inventory regulatory frameworks for nanotechnology in food and medical products.”