Is FDA “Over-Regulating” Some Low-Risk Products?
​[Posted on: Thursday, October 6, 2016]

In recent years, FDA has reversed its policy of enforcement discretion for several products whereby certain products were regulated less due to lower perceived risk. Two of such cases have garnered wide-spread criticism. Late last year, FDA released several new guidance documents to create new stricter rules for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). In May of this year, FDA added electronic cigarettes to the list of tobacco products even when the nicotine used in such products was not of tobacco-origin. These FDA decisions have been criticized by the industry as “over-regulation” with wide-spread negative public opinions. Last month FDA held two public hearings on its new guidance documents for HCT/Ps where more than 100 companies made presentations asking FDA to revise its proposed guidance to reduce the regulatory burden on the developers of such products. The FDA docket on regulation of HCT/Ps received an unprecedented 6949 comments asking FDA to not regulate certain kinds of HCT/Ps. There is strong disagreement between FDA and the industry regarding definition and regulatory interpretation of HCT/Ps. Of particular debate is the regulation of autologous stem cells which basically are stem cells harvested from one tissue of an individual for use in another tissue of the same individual. There were more than 1000 comments on the FDA docket claiming that FDA should not regulate the practice of a doctor harvesting cells from an individual for use in the same individual. One can argue that since such cellular therapies have been available for more than 2 decades, been used in hundreds of thousands of patients with no reports of any major adverse events linked to the use of such cellular therapies, should FDA stick to its policy of enforcement discretion. FDA seems to be ready for the argument and doesn’t seem to back down but may be the public outcry will make FDA change its mind. Similarly FDA’s inclusion of electronic cigarettes in the list of tobacco products with the associated extensive regulatory burden has been strongly criticized by practically all parties: consumers, industry and media. There is no clear evidence that inhaling water-based fumes containing synthetic nicotine has the same negative effects as conventional cigarettes. On the contrary, electronic cigarettes have been proposed to be smoking cessation products and studies have indicated they may be much safer than other tobacco products. The tobacco industry does not support electronic cigarettes as it cuts into the market for its products, and the electronic cigarette industry is mostly composed of small manufacturers who do not have the resources to fight FDA. But this episode has surely given FDA significant negative press. Once might argue if FDA’s resources are best used in not aggressively pursuing such products. If such decisions from FDA even help the public health. It is food for thought for all of us.