Nanotechnology-related products and materials are becoming increasingly prevalent in our society. In the U.S., much of the burden for regulating these products falls upon the Food and Drug Administration (FDA). Thus far, the FDA has insisted that its present regulatory scheme is adequate to the task of analyzing nanotechnology products. Other administrative agencies, however, have recognized the special properties that can attach to nanosized materials. For example, the U.S. Patent and Trademark Office (USPTO) has created a special cross-reference classification: Class 977. By cross-referencing an application or a patent under Class 977, the USPTO provides strong evidence that the invention has novel, nanotechnology-related properties—yet that invention, once submitted to the FDA for approval, will be treated exactly the same as its large-scale counterpart.
This note challenges the FDA's premise that nanotechnology-related products pose no special concern by providing evidence that nanomaterials may have very different physical and toxicological properties than their large-scale counterparts. Further, many of these materials are used in products where the FDA has the weakest regulatory authority, such as in cosmetics and "generally recognized as safe" food supplements. This regulatory gap can be filled in part by making use of the USPTO's classification scheme to identify those products likely to pose special safety challenges. Once a Class 977-labeled invention is submitted to the FDA, this note argues that the product should be classified as a new product for safety and legal purposes. This would give the FDA the ability to use its labeling powers to force public disclosure of products containing nanosized material, and to strongly encourage manufacturers to engage in additional safety research. Further, this note argues that the Class 977 label should create a presumption within the FDA that the product is likely to fall within more than one regulatory category. The FDA can then use its Office of Combination Products and relevant regulations to ensure that the products receive the safety evaluation they need.
Jessica K. Fender,
The FDA and Nano: Big Problems with Tiny Technology,
Chi.-Kent L. Rev.
Available at: https://scholarship.kentlaw.iit.edu/cklawreview/vol83/iss2/22