A group that describes itself as a “corporate responsibility group” and goes by the name “As You Sow” has recently been investigating and speaking out on the subject of nanomaterials in foods and food packaging. As part of its efforts, the group recently issued a report titled “Slipping Through the Cracks: An Issue Brief on Nanomaterials in Foods.” The report was the subject of a recent article in The New York Times, and has also been covered by other news outlets and blogs.
As You Sow has identified what it claims to be a number of concerns involving the use of nanomaterials relating to foods, including: food packaging, foods or food ingredients/additives, nanofeed (especially for chickens), nanoparticle pesticides and nanoparticle materials added to farmed fish ponds (especially nanoparticle vaccines).
According to the report, As You Sow sent a survey to 2,500 corporations asking them about their practices with respect to nanomaterials. The group claims it only received responses from 26 of those companies, with only 14 of those responding companies stating that they don’t use nanomaterials.
As You Sow also claims it conducted independent laboratory testing on two commercially-available white powdered sugar donut products to determine whether they contain titanium dioxide particles within the nanoscale. According to the group, both donut products tested positive for titanium dioxide particles with a size of 10 nanometers or smaller. The group acknowledged, however, that it does not know whether these nanoparticles were engineered, or just a byproduct of the manufacturing process.
The distinction between nanoparticles that are engineered, and those that are naturally occurring or simply the byproduct of ordinary manufacturing process, could potentially be significant to a food’s status as Generally Recognized as Safe (“GRAS”), in light of the Food and Drug Administration’s (“FDA’s”) proposed guidances relating to nanotechnology. A June 2011 proposed guidance (Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology) stated that FDA would only consider a product to involve nanotechnology if it is “an engineered material or end product.
An April 2012 draft guidance (Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives) likewise focused on intentional alteration of particle size. In the April 2012 draft guidance. FDA stated: “At this time, we are not aware of any food ingredient or [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 [food contact substance] is GRAS.”
As You Sow has stated that it intends, in the near future, to continue testing more food products for the presence of nanoparticles. Considering that FDA has not yet promulgated any final rules, regulations, or guidances relating to nanomaterials in foods, it is unclear whether FDA will take any enforcement action with respect to nanomaterials in foods at this time. Plaintiffs’ class action counsel, however, may attempt to use test results (whether released by As You Sow, by another group, or undertaken by plaintiffs’ counsel themselves) as the basis for filing consumer class action lawsuits. Consumer class actions, particularly those involving alleged misrepresentations made in food labeling and advertising, have become increasingly popular over the last few years. Plaintiffs’ counsel may view the unlabeled presence of nanoparticles in foods as similar to the unlabeled presence of genetically modified organisms (“GMOs”) in foods – an issue which has been the subject of several consumer class action lawsuits.
Given the potential risk of litigation and/or regulatory action, it is critical that food industry companies, including companies that purchase food packaging materials or food ingredients from other entities, know whether their finished products or packaging contain nanomaterials, and know how those nanomaterials came to be in their products. Food industry companies will also need to consult with experienced counsel to consider how best to evaluate and manage the potential risk in a proactive manner.
Nilda M. Isidro contributed to the preparation of this alert.