The agencies are focusing on vaping manufacturers in order to “[follow] the supply chain to its source.”
The Drug Enforcement Administration (DEA) will assist the Food and Drug Administration (FDA) in its investigation into the spate of vaping-related illnesses that have sickened more than 1,000 and claimed at least 18 lives.
In testimony before a House Energy and Commerce subcommittee on September 25, acting FDA Commissioner Dr. Ned Sharpless said that the agencies will collaborate to determine “if someone is manufacturing or distributing illicit, adulterated products that caused illness or death for personal profit,” which would be considered a criminal act.
FDA Waited Too Long To Review Vaping Products
Sharpless acknowledged that the FDA should not have waited to review e-cigarette products, a decision which some lawmakers have said was a contributing factor in the rise of teen e-cigarette use.
Sharpless’s testimony came on the heels of the FDA’s announcement of a criminal problem into the rash of vaping illnesses, which they announced on September 19. He mentioned that the decision to bring the DEA into the probe is due to the number of illnesses and deaths related to the use of vaping cartridges containing THC.
As for the focus of the probe, Sharpless said that the agencies are focusing on vaping manufacturers in order to “[follow] the supply chain to its source.”
Additionally, Sharpless said that the FDA plans to finalize a draft of new guidance for flavored vaping products. Warning letters will be sent to manufacturers that do not remove those products—save for those that are flavored like tobacco—from the market. Those that do not comply may be subjected to additional warning letters, as well as possible fines and injunctions.
Why Did The FDA Take So Long to Act?
But lawmakers on the subcommittee also wanted to know why the agency appeared to wait nearly three years in order to take action in regard to e-cigarettes.
The FDA asked companies in 2016 to file applications to market products by August of 2018, but as STAT News noted, former FDA Commissioner Scott Gottlieb shifted the agency’s focus to curbing nicotine levels in traditional cigarettes, while also delaying the marketing applications to 2022 (the deadline has since been moved to May 2020).
In response to the subcommittee’s inquiries, Sharpless said that the “FDA should’ve acted sooner,” but added that the probe, and the addition of the DEA to its efforts, should help them “catch up.”
“We will not rest until we have answers to the questions in the investigation, and until we have dramatically reduced the access and appeal of e-cigarettes to kids,” he said.