Guidance documents issued by the FDA in late June describe the agency’s “current thinking” on its approach to regulation of nanotechnology products, including its use in food production. The FDA states that use of nanotechnology is not “intrinsically benign or harmful.”
One FDA document addresses the agency’s overall approach to use of nanotechnology in all products that it regulates, and another is specifically focused on nanotechnology used in the manufacture of food contact substances and food ingredients, which includes food additives, color additives, and those generally recognized as safe (GRAS). The documents are intended to help industry identify when it should consider any potential implications for regulatory status, safety, effectiveness, or impact on public health that could be introduced by nanotechnology in FDA-regulated products.
The document alerts manufacturers to the potential impact of any significant manufacturing process change, such as nanotechnology, and the safety and regulatory status of food substances. The agency recommends that it be consulted when any significant manufacturing process change is made for a food substance already on the market, “irrespective of [the manufacturer’s] conclusion about whether that change affects the safety or regulatory status of the food substance.”
According to FDA spokesperson Jeff Ventura, FDA guidelines are recommendations and are not legally enforceable responsibilities. Some technologies, however, “could be so new as to preclude a consensus among experts that the use of a food substances manufactured using that technology is safe, thus precluding a determination that the use of the food substance is GRAS. Therefore, it is likely that premarket review and approval of the food substance on a case-by-case basis by the agency is warranted,” he says.
In a press release, Center for Food Safety notes that the FDA guidance clarifies that nanochemicals constitute a new food technology and that the agency recognizes the need for careful review. Jaydee Hanson, senior policy analyst for Center for Food Safety, says that the FDA needs to go further. “Under these guidelines, companies will consult with the FDA, but the FDA will not review products for safety. Guidances alone are not sufficient to account for the novel risks of nanotechnology. FDA must issue mandatory regulations,” she says.
“FDA should categorically state that GRAS approval cannot be used for nanochemicals in foods,” Ms. Hanson says. “We know far too little about the human health and environmental effects of this technology to allow it to slip into our food without rigorous assessment.”