Regulating in Uncertainty: Animating the Public Health Product Safety Net to Capture Consumer Products Regulated by the FDA that Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, and Lab Grown Meat
Katharine A. Van Tassel
University of Akron, School of Law
October 13, 2013
University of Chicago Legal Forum, 2013
U of Akron Legal Studies Research Paper No. 13-09
The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.
Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer products to meet the twin goals of protecting public health while fostering innovation. However, the current litmus test that the FDA is using to trigger regulation to protect public health is focused on hazard. Linking public health protections to the degree of hazard when operating in the area of scientific uncertainty that prevails with most novel technologies is outcome determinative – it means no public health regulatory protection at all.
This Article will use nanotechnology as the main example that highlights how a simple change in focus to regulating innovative ingredients based on novelty rather than hazard can achieve the proper balance between protecting public health while encouraging innovation. Novel ingredients should be listed on product ingredient labels to allow for the use of big data strategies to link health impact information collected from electronic health records and social media, to the data generated by the state and federal consumer product reporting systems. Linking these data streams will create a highly sensitive, state-of-the-art product safety surveillance system. This system will work to identify early warnings of product safety problems so that public health officials can proactively mitigate their effects.
This focus on novelty and big data strategies will animate what this Article calls the “public health product safety net.” As envisioned by this Article, the public health product safety net is a powerful, interactive network that involves consumers as well as the healthcare system, the state and federal public health protection agencies, and the tort system. Together, these private and public actors can act to ensure consumer safety through: (1) consumer self-protection; (2) appropriate injury treatment by healthcare providers using the correct identification of novel ingredients as causative agents; (3) proper reporting of the injury-causing agents to the state and federal public health protection agencies in charge of the early warning and product recall systems; and, (4) the instrumental use of the tort system to both encourage the proper investment in product safety and to insulate against the overuse and overconsumption of relatively risky products.
After walking through how the public health product safety net will operate to achieve the proper balance between public health protection and fostering innovation in the context of nanotech ingredients in consumer products, this Article will show how this safety net will work with other novel technologies used as ingredients in consumer products such as cloned animals, genetically modified plants and animals used for food, cloned animals used for food and lab grown meat.
This Article concludes by pointing out that the exploding number and variety of novel ingredients never seen before in nature will be limited only by the ingenuity of engineers and scientists creating these novel ingredients. As such, it is time to put into place a post market surveillance system to protect public health that will work for all of these novel ingredients, regardless of their composition – and that system is the public health product safety net described in this Article.
Number of Pages in PDF File: 56
Keywords: nanotechnology, genetically modified food, GM food, GMOs, lab grown meat, innovative technologies, regulating in uncertainty, FDA, Food & Drug Law, consumer products, product liability, post market surveillance
Date posted: March 30, 2013 ; Last revised: June 1, 2014