By Ricardo Carvajal -
April was a busy month for nanotechnology at FDA. The agency issued two draft guidance documents worthy of close examination for those with an interest in the use of emerging technologies, including nanotechnology, in the cosmetic and food industries. Further, FDA denied a citizen petition asking the agency to stop the marketing of sunscreen drug products that contain engineered nanoparticles of zinc oxide and titanium dioxide.
The first draft guidance document, Safety of Nanomaterials in Cosmetic Products, begins by emphasizing manufacturers’ responsibility to substantiate the safety of their products prior to marketing. It then notes that different properties of materials might emerge at the nanoscale such that standard safety tests “may not be fully applicable,” and that such tests “may need to be modified or new methods developed” to address effects on toxicity and functionality. The remainder of the guidance discusses nanomaterial characterization and toxicology considerations in some detail, and encourages manufacturers who wish to use nanomaterials in cosmetics to consult with FDA.
The second draft guidance document, Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food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, is not strictly limited to nanotechnology. However, it is clear that changes in manufacturing processes that arise as the result of the use of nanotechnology are a principal concern. As with the cosmetics guidance discussed above, the food guidance begins by emphasizing manufacturers’ responsibility to ensure that their products are safe and lawful. It then discusses the legal framework for food and color additives, as well as FDA’s approach to assessing the safety of food substances. Finally, it presents considerations and recommendations for assessing the potential impacts of significant manufacturing changes (e.g., changes in starting materials, catalysts, or manufacturing technologies) on safety and regulatory status.
FDA cites both of the above guidance documents in its partial denial of a citizen petition submitted by the International Center for Technology Assessment ("ICTA") in May 2006. That petition, which preceded the creation of FDA’s Nanotechnology Task Force, asked the agency to create a new regulatory framework specific to nanoscale particles, and for product recalls and a development moratorium for sunscreen drug products that contain engineered nanoparticles of zinc oxide and titanium dioxide. FDA’s response to the citizen petition lays out a thorough defense of the agency’s current approach to nanotechnology – including the agency’s position that adoption of a nanotechnology-specific regulatory framework currently is not appropriate “as a matter of science and policy.”
Although FDA cites progress in its response to the challenges posed by nanotechnology, the latest report on the National Nanotechnology Initiative ("NNI") by the President’s Council of Advisors on Science and Technology ("PCAST") concludes that “individual agency contributions” to the NNI strategic plan “lack the cohesion of an overarching framework.” Currently, FDA is one of only a few agencies that have a strategic research plan for nanotechnology. According to PCAST, “[t]he process for producing the strategic plan is still agency-driven, which could limit the broader NNI vision to those objectives that agency officials feel are sufficiently within reach. Also lacking is a clear connection between the goals and objectives of the NNI strategic plan and those of individual agencies.” PCAST makes numerous recommendations in relation to strategic planning, program management, metrics to track progress, and efforts to address environment, health, and safety risks. As noted in the PCAST report, research and development in nanotechnology continue to be of great interest to governments and industries worldwide.