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CU comments to FDA to regulate nanotech materials

Comments of Consumers Union at FDA Nanotechnology Public Meeting
Breakout session on Food and color additives, including food contact substances
Michael Hansen
Senior Scientist
Consumers Union
September 8, 2008

The basic position of Consumers Union urges FDA to recognize that nanoscale particles exhibit novel properties and/or behaviors, compared to their larger counterparts, and raise unique safety concerns, so that a separate safety assessment must be required before such nanoscale particles/materials can be used for any food ingredient or packaging component that comes in contact with food. We, thus, agree with the recommendation of the UK Royal Society, and the European Commission’s expert panel, which have stated that nanoparticles should be considered different that the normal size counterparts and separate safety assessments should be performed on them. Furthermore, FDA should require labeling of such ingredients immediately
1. Can you identify specific classes of food ingredients or packaging components derived from or incorporating nanotechnology that you would identify as raising or not raising unique safety concerns and why?
In general, no. Consumers Union believes that any use of nanotechnology, particularly the use of “engineered nanoscale materials” (ENM) (defined as a material purposefully manipulated at nanoscale that exhibits novel properties and/or behaviors as a result) for food and color additives, including food contact substances should require a full food additive petition (FAP) for the ENM, even if the macroscale version of the substance in questions has previously been granted a FAP. In other words, we want FDA to recognize that ENMs have the potential for structure-dependent health effects that are uniquely different than their larger counterparts and raise toxicity questions.
In this regard, we agree with the conclusions of the July 2004 report of UK Royal Society and Royal Academy of Engineering, which concluded, “We believe that chemicals in the form of nanoparticles and nanotubes should be treated separately to those produced in a larger form. Given the evidence that increased surface area can lead to greater toxicity per unit mass, regulation of exposure on a mass basis to nanoparticles and nanotubes may not be appropriate.” As a particle gets smaller and smaller, the ratio of surface area to volume/mass increases exponentially. Thus, the surface area of 100 grams of lead in a sphere 2.6 centimeters in diameter is 0.0002 m². If that particle size is reduced from 2.6 cm to 50 nm (nanometers), the total surface area is over 1,000 m² or 500,000-fold (or almost 6 orders of magnitude) greater. The drastically greater surface area means potentially greater reactivity with biological or chemical materials around them—such as increased reactivity with the immune system.
For the full comments, click here (PDF format).