FDA warns Juul for marketing with unproven safety claims
FDA Monday warned e-cigarette maker Juul to stop marketing its vapes as much safer than other tobacco products without sufficient evidence this is true.
Juul “has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” acting FDA Commissioner Ned Sharpless said in a news release. FDA gave Juul 15 working days to respond to its warning letter and correct the violations.
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E-cigarettes may be safer than traditional tobacco, but their producers must demonstrate evidence of this to FDA before making such a claim, Sharpless said.
FDA cited documents that came to light during a House Oversight and Reform subcommittee hearing in July, including testimony that Juul reached out to high schools and American Indian tribes for partnerships. The agency sent a separate letter requesting details on those practices and asking for all Juul’s communications with health insurers and providers as well.
FDA asked for the documents within 30 days. Juul is reviewing the letters and “will fully cooperate,” a spokesperson said.
The warning letter comes amid a rash of mysterious vaping-related lung disease including five confirmed deaths across the country. Public health officials have warned the public against using counterfeit and marijuana vapes, but also suggested that all vape users consider stopping while it pinpoints the cause or causes of the outbreak.
The agency has been under pressure to tighten restrictions on the e-cigarette industry. Sen. Dick Durbin (D-Ill.) has called on Sharpless to take such actions or resign.
FDA inspected Juul offices late last year and seized documents tied to an earlier ad campaign. FTC has also launched a probe into Juul marketing practices, as has the House Oversight and Reform subcommittee on Economic and Consumer Policy.