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FDA warns Juul for marketing with unproven safety claims

  • September 11, 2019
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FDA warns Juul for marketing with unproven safety claims

By Elaine Owen, Editor

U.S. Food and Drug Administration (FDA) warned e-cigarette maker Juul Monday (Sept. 9) to stop marketing its vapes as much safer than other tobacco products without sufficient evidence this is true.

Acting FDA Commissioner Ned Sharpless said in a news release, “Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.” FDA gave Juul 15 working days to respond to its warning letter and correct the violations.

Sharpless added that E-cigarettes may be safer than traditional tobacco but their producers must demonstrate evidence of this to FDA before making such a claim. 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, according to a spokesperson, “will fully cooperate.”

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.

Late last year FDA inspected Juul offices and seized documents tied to an earlier ad campaign. FTC has also launched a probe into Juul’s marketing practices, as has the House Oversight and Reform subcommittee on Economic and Consumer Policy.