Beginning this summer, the Food and Drug Administration (FDA) through its Office of Criminal Investigations, launched a criminal probe to investigate the vaping-related lung illnesses that have affected over five hundred people across the United States. The Centers for Disease Control and Prevention (CDC) has a parallel investigation tracking the incidences of the illness. Both the FDA and CDC are working with state and local health officials to investigate the increasing number of cases nationwide.
Possible sources of the illnesses include additions of cutting agents, other additives, and Vitamin E acetate to vaping cartridges, although there is uncertainty about the exact source. The FDA is cautioning consumers about the use of vaping products that have been modified or sold on the black market. Consumers are also encouraged to speak candidly with clinicians and provide information to the FDA through its Safety Reporting Portal. Healthcare providers have been encouraged to report possible cases to state and local health officials.
Clients that market vaping products, including vaping products not designed for use with tobacco, should be on alert for the possibility of FDA or state-contract inspections. Companies that market hemp and cannabis oils and extracts, including cannabidiol, should also be on alert. Should you be subject to an FDA inspection or regulatory action, it is strongly recommended that you contact your attorney for assistance.
Husch Blackwell has experience working with manufacturers and suppliers on FDA regulatory matters, and regularly advises tobacco and industrial help manufacturers. Our FDA regulatory lawyers are available to discuss these developments and how companies can appropriately prepare for an FDA inspection. Contact Seth Mailhot, Steve Levine or your Husch Blackwell attorney.
Husch Blackwell Fall clerk Julia Banegas was a contributor of this content.