Nanotechnology is a cutting edge technology which involves the use of engineered, non-soluble material so tiny, it cannot be seen through a light microscope. Through manipulation of the chemical, physical and biological properties of nanomaterials, manufacturers can significantly alter the product into which they are added. The potential capabilities of this technology in the food industry are endless. For instance, nanotechnology may be used in food packaging to keep products fresher and increase shelf life. Moreover, nano-based compounds can be used in food to enhance flavor or provide additional vitamins and minerals.
On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance which addresses, among other things, the use of nanotechnology in food manufacturing and packaging materials. Though not legally binding, the draft guidance provides manufacturers with significant insight into the FDA’s current thinking on the use of nanomaterials in food products and packaging, as well as the direction in which the FDA may head in the future. The FDA makes it very clear as to its view on the potential risk such technologies present to both the consumer and food industry:
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.
USA Today News reported that based upon the draft guidance, it appears that the FDA will place increased scrutiny upon food products and packaging which utilize nanotechnology. The draft guidance provides criteria to be used by food manufacturers to determine whether changes to the manufacturing process, including the use of nanotechnology, are authorized under the food additive or color additive regulations. According to the draft guidance, changes which utilize nanotechnology would likely fall outside the purview of those regulations, and therefore would be subject to increased regulatory scrutiny. A recent article written by Chicago Tribune reporter Anna Yukhananov, reported that companies which utilize engineered nanoparticles in the manufacture of a particular food or food packaging may be required to affirmatively demonstrate, through additional testing, that their product is safe before they can introduce the product into the market. Further, that the food manufacturers which utilize nanotechnology are “encouraged” to make regulatory submissions to the FDA for its approval before marketing the product, a process which is not required before a company can sell products which use approved additives.
The FDA’s recent draft guidance suggests that it will be cautious and thorough in its oversight of nanotechnology. The long-term impact of the use of engineered nanoparticles is largely unknown, and the FDA is scrambling to get ahead of the curve. By imposing heightened regulatory requirements on companies who wish to utilize nanotechnology in their products, the FDA will transfer the responsibility and cost of assessing the safety of this new technology onto the food industry. The FDA’s stance will likely result in a delay in the introduction into the marketplace of products which incorporate nanotechnology, as company’s assess whether the benefits outweigh the costs of product development and the regulatory hurdles likely to be imposed by the FDA.