FDA Issues Suggested Guidelines On Nanotechnology In Food and Cosmetics
In April of 2012, FDA issued a draft guidance for the use of nanotechnology in both food and cosmetics. While a draft guidance does not technically establish “legally enforceable responsibilities,” its purpose is to provide an agency’s thinking on a particular issue in the form of tentative guidelines—here being the use of nanotechnology in food. The draft guidance opens a period for comment from industry participants as to their opinion of the effect if the draft guidance were to be implemented as a regulatory standard.
In this particular draft guidance, FDA has opined that the use of nanotechnology in food may require additional “scrutiny” and, thus, it is best practice for industry participants using nanotechnology in food substances to consult FDA prior to marketing such products:
As with all food substances, this guidance also is intended to recommend that you consult with us regarding a significant change in manufacturing process for a food substance already in the market, irrespective of your conclusion about whether that change affects the safety or regulatory status of the food substance. It is prudent practice for you to do so, particularly when the change in manufacturing process involves emerging technology. Food substances may be used in a wide array of products manufactured, distributed and sold at retail by a large number of firms. The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant.
If implemented, the draft guidance may have significant impact on both the manufacturers using nanotechnology in their food substances and the nanotechnology firms developing and marketing nanotech applications for food substances as the use of nanotechnology in food will almost certainly increase in cost for all. Requiring FDA consultation prior to taking a nanotech food application to market, including the necessary research and/or studies substantiating the safety of the intended nanotech food use to FDA, will create regulatory hurdles, lengthening the time and increasing the expense of developing and marketing nanotech food products and applications.
Moreover, food substance manufacturers will likely require a more thoroughly reviewed safety profile of the intended use from nanotech firms both to convince the FDA as to the safety of its application and as “insurance” against future product liability claims. In light of the FDA draft guidance, failure to properly investigate the safety risks of a nanotech application in food prior to marketing by either the nanotech firm marketing the nanotech application or the food manufacturer using the nanotech application in its food substances could expose both entities to liability from future product liability claims as the draft guidance will certainly be used as a standard for reasonable industry conduct. Notably, even if the draft guidance is not implemented by FDA for some years to come, its issuance in itself can arguably be an informal standard of the “reasonableness” of a company’s actions and practices in the context of a product liability lawsuit. Thus, any deviation from the draft guidance can be fodder for product liability lawsuits.
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