Nanotechnology in food: Tell the FDA to put consumer health first

Amazingly, the FDA currently does not regulate the use of nanotechnology in food, despite its widespread use, and serious public health concerns. We need to let the FDA know that the use of nanotechnology in food products needs strong pre-market, public health protections. July 24 is the deadline for public comment on the U.S. Food and Drug Administration’s (FDA) draft guidance to industry on the use of nanotechnology in food.

The incorporation of atomic- to molecular-sized Engineered Nanoscale Materials (ENMs) is supposed to have benefits both for food manufacturers and consumers. For example, coating food conveyer belts with nano-silicon dioxide could, in theory, prevent pathogen growth, make the belts easier to clean and reduce the likelihood of contamination of the food carried on the conveyor belts, but we know very little about the health effects of exposure to ENMs. What we do know is cause for alarm.

Scientific research indicates that ENMs pose significant health risks if inhaled or spread on the skin. A 2012 National Research Council study notes that “there is little progress” on research about the human health effects of ENM oral consumption. You can read more about the absence of regulation of nanotechnology in IATP’s report from last year, Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation.

This new FDA guidance on nanotechnology and food should become a basis for mandatory regulation that protects public health. Take action today and make your voice heard. Urge FDA to regulate nanotechnology to protect consumer health.

Subject:

Your Letter:

It is shocking that FDA does not yet regulate the use of ENMs in food ingredients, given that nanomaterials, such as nano-titanium dioxide, are reportedly widely present in food ingredients.  A 2012 National Research Council report found that “there is little progress” on research into the effect of oral consumption of ENMs on human health. The FDA should commission, finance and publish such research as an urgent public health priority, and a basis for regulation. The FDA’s draft guidance to industry should be a first step towards regulation to protect public health and the environment.
 
First, I agree with FDA’s recommendation to industry that it consult with FDA whenever it uses ENMs as a food ingredient, whether or not an ENM product developer believes that the food ingredient with ENMs is safe for human consumption. Consultation documents and meeting minutes should be published on the FDA’s website, with a stringent limit on the ability of product developers to claim unilaterally that consultation information be omitted from the public record as Confidential Business Information.

Second, I agree with FDA’s position that industry should not assume a macro-scale food ingredient that is Generally Recognized as Safe (GRAS) to be safe in its nano-scale version. All ENMs used as food ingredients should be subject to a pre-market safety assessment. FDA should withdraw from the market all products shown to contain ENM food ingredients that have not undergone the pre-market safety assessment and been shown to be safe for daily human consumption.

Third, FDA should organize public consultations on the regulatory concept of industry’s “self-limiting levels of use” of food ingredients. The novel properties of and unique hazards posed by ENMs require a thorough revision of the “self-limiting levels of use” concept and criteria in order to protect public health.

I hope that the final guidance will reflect the aforementioned views, following the proposed public consultations.

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
US