On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries. Both encourage manufacturers to consult with FDA before taking their products to market and warn that companies may need to perform additional safety tests or resubmit products for approval if their products incorporate nanotechnology. FDA noted, however, that the two guidance documents are not intended to provide guidance to manufacturers about the use of nanomaterials in other FDA-regulated products, such as drugs or medical devices. Public comment is invited, although official publication of the drafts has not yet been scheduled.
Food Draft Guidance
The food draft guidance addresses manufacturers and end users of food ingredients and food contact substances (FCSs). It is intended to describe the factors for determining whether a significant change in the manufacturing process for a food substance affects the identity, safety, or regulatory status, or warrants a regulatory submission to FDA of the food substance already on the market.
In particular, FDA noted that “[a]lterations in particle size distribution on the nanometer scale, which alter the physical and/or chemical properties of food ingredients and FCSs, can sometimes be significant manufacturing changes.” Therefore, physico-chemical structure, properties, purities, and impurities should be taken into account when determining whether significant changes have been made to the food or contact substance (such as packaging). In addition, FDA recommends conducting a safety assessment, taking into account the bioavailabilty and toxicity of the food or contact substance.
Cosmetics Draft Guidance
The cosmetics draft guidance notes that the legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products, and they must be properly labeled in accordance with FDA regulations. FDA advises manufacturers to conduct safety assessments for cosmetic products containing nanomaterials, noting standard safety tests may need to be modified or new methods developed to take into account physico-chemical structure and particular testing conditions.
FDA oversight of cosmetics has remained a priority for Congress. On April 18, 2012, Rep. Leonard Lance (R-NJ) introduced the Cosmetic Safety Amendments Act of 2012 (H.R. 4395), which would overhaul FDA’s oversight of the cosmetics industry, expanding the agency’s role in assessing the safety of cosmetics. We will continue to monitor this proposed legislation and provide updates as it makes its way through Congress.