Will the FDA Dance on the Head of a Pin?
Nanotechnology is the science and engineering of atomic particles that range in size from 1 to 100 nanometers (a billionth of a meter). For comparison’s sake, a piece of paper is 100,000 nanometers thick, and a single strand of hair is 800,000 nanometers in diameter. How can something so small it cannot be viewed with a traditional microscope radically affect the food and beverage industry? Recent legislation by Congress and recently released draft guidance from the Food and Drug Administration (FDA) suggest that the FDA may soon seek to regulate nanoparticles in food and to reassess whether such foods should remain on the Generally Recognized as Safe, or GRAS, list.
Modern technological developments now permit manufacturers to deliberately manipulate nanoparticles. Advocates maintain that such “nanomanufacturing” creates improved materials and new products, helping food taste more flavorful and stay fresher. For example, nanoengineered materials minimize carbon dioxide leakage from carbonated beverages and reduce oxygen inflow, moisture outflow and the growth of bacteria, for the purpose of keeping food fresher and safer, longer. Some believe that nanotechnology will revolutionize our world and profoundly improve our standard of living. To a certain extent, it already has: in 2010 the National Science Foundation estimated nanotechnology-based products would contribute two million jobs and $1 trillion in revenue to the world’s economy by 2015. Other groups more than double the global estimation to $2.4 trillion by 2015.
However, not all researchers agree that nanotechnology is beneficial. Recently, critics have started calling for more regulation in the food industry, arguing that engineered nanomaterials should be prohibited entirely in food products until the safety of such materials is known, which could require decades of additional research, with cost running into billions of dollars. These critics cite published studies in which various engineered nanomaterials, such as nanosilver (which can be found in food storage containers) or certain strains of carbon nanotubes, were found to be toxic. In 2010 the Government Accountability Office blasted the FDA for its failure to monitor the inclusion of nanoparticles in GRAS substances and called on the agency to extend its oversight of such materials, pointing to regulations in Canada and the European Union that require manufacturers to submit to authorities a list of all food ingredients containing engineered nanomaterials.
Those critics are now finding a voice in Congress and the FDA. In April of this year, reiterating that understanding nanoparticles was a top priority, the FDA took a step closer to regulating nanomaterials by releasing additional draft guidance specifically targeted at food products and cosmetics. In the guidance, the FDA alerted manufacturers to the potential impact of any significant manufacturing process change and warned that such changes could require additional FDA review and status changes, such as removing certain products from GRAS lists.
The government has recently and dramatically increased funding to the National Nanotechnology Initiative, or NNI, which — although founded in 2001 — will have a FY2013 budget of more than $1.8 billion and a mandate from the White House to coordinate nanotechnology research and regulation across 26 different government agencies, including the FDA, through various committees and working groups. Fifteen federal agencies now conduct nanotechnology research.
The FDA has also increased its participation in the nanotechnology arena. Recognizing that this new science could radically change food products, in 2006 the FDA created the Nanotechnology Task Force, commissioned with studying the emerging technology, possible adverse health effects from nanomanufactured products, and the adequacy and application of the FDA’s regulatory authorities to the field. A year later, the task force released its report, which called for the development of guidance clarifying how current FDA regulations could change the status of food products containing nanomaterials. In June 2011 the FDA began implementing the report’s recommendations by releasing draft guidance on which FDA-regulated products involved the application of nanotechnology. The guidance, which was published in the Federal Register and is still available for comment, provided some definition of what the FDA considered nanomaterials and what could be regulated by the agency.
The expectation is that this area of the food and beverage industry will see significant changes and developments in the coming months and years. McGuireWoods LLP closely follows these nanotechnology developments, and its Food and Beverage Industry group includes attorneys with significant experience in this emerging technology who can help clients comply with applicable laws and regulatory requirements and help shape emerging regulations and legislation.