The FDA is on the move. OnApril 20, 2012, it issued two draft guidances pertaining to the effects of nanotechnology on food and cosmetics. In the cosmetics document, the FDA cautions safety and does little more. But in the food safety document, the FDA moves in the directing of setting forth steps to be taken by food manufacturers to prove the safety of any food and food packaging using nanotechnology. This heightened scrutiny for food products containing nanoparticles is an affirmative move on the part of the FDA to regulate nanotechnology.
In the April 20 food safety guidance document, the FDA states:
“The manufacturing process of a food substance is considered for the purposes of safety assessment only insofar as it may affect the properties and safety of the finished product.”
The FDA goes on to say that “[t]he particle size distribution of a food substance may affect its ability to be absorbed by the body or to migrate from food packaging into food.” The FDA explicitly states that manufacturing processes involving nanotechnology are included within the scope of the guidance document.
The FDA states that it does not intend to judge any substances containing nanoparticles as being harmful – or not – but that use of nanotechnology in food may warrant certain assessments in determining the safety of the food. The FDA states:
“The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. . . . For example, so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”
In other words, safety assessments in this area should be based on criteria for food substances in the nanometer range, and that could require new and different assessment methodologies. However, the FDA has said that it will continue to regulate nanotechnology products under its existing statutory authorities, e.g. regulations on food color, additives, and packaging.
So does the guidance represent a step forward? I think it does, if for no other reason than it explicitly recognizes that there may be discrete safety issues raised by the use of nanotechnology in food. The guidance is not self-executing; it is currently available for public comment. It represents a step in the right direction. Its recommendations are preliminary, it seems to me. Going forward, further consideration needs to be given to the issues it raises to determine if regulation specific to products using nanotechnology is warranted. This should be only the beginning.
The draft guidance is Draft Guidance for Industry: 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, available at
