The Trump administration is planning to ban all non-tobacco flavored vaping products from the market in the wake of reports of deaths and diseases related to vaping.
President Donald Trump met on Sept. 11 with acting U.S. Food and Drug Administration Commissioner Ned Sharpless and Secretary of Health and Human Services Alex Azar at the White House to discuss issues related to vaping.
It will take several weeks for the FDA to finalize a guidance document for flavored e-cigarette products, Azar said. Then there would be a 30-day period before all flavored e-cigarettes, other than tobacco-flavored offerings , would have to be removed from the market, he said.
Manufacturers of tobacco-flavored e-cigarettes would have to file by May 2020 with the FDA to get approval for their products, Azar said.
"The other flavored product manufacturers can, at any time, also file, but they would be off the market until approved by FDA," Azar said.
Preliminary numbers from the National Youth Tobacco Survey show a continued rise in the rates of youth e-cigarette use, especially through the use of non-tobacco flavors, according to HHS. About 8 million adults use e-cigarettes and 5 million children are using e-cigarettes, Azar said.
Days before Trump's proposal to clear the market of non-tobacco flavored e-cigarettes, the FDA blamed Juul Labs Inc. for an "epidemic of youth use" of its products and warned the company about making unauthorized health claims for its products.
Juul no longer distributes its non-tobacco and non-menthol based products to retailers but still sells them on its website. In an emailed statement, a Juul spokesperson said that the company strongly agrees "with the need for aggressive category-wide action on flavored products," and will "fully comply with the final FDA policy when effective."
A spokesperson for Altria Group Inc., which has a 35% stake in Juul, said in an email it agreed that "urgent action is needed and we look forward to reviewing the guidance." Reducing youth-use of e-vapor products is a top priority for Altria, the spokesperson said.
All the negative attention surrounding e-cigarettes does not necessarily translate to bad news for a company like Altria, Christopher Growe, a Stifel analyst, said in a Sept. 11 report.
"We view these headlines as negative for E-cig companies including JUUL," Stifel said. "But, with no E-cig business of its own, we believe the headlines, if anything, are positive for Altria – further regulation of E-cigs would likely support a stronger cigarette performance for the company trumping any lost value in its JUUL stake."
British American Tobacco PLC said it welcomed the Trump Administration and the FDA putting a spotlight on the issue of youth access to vapor products.
"We will continue working with the Administration regarding proposed changes moving forward over the coming months, and feel confident in our planned [premarket tobacco product application] submissions to the FDA," a British American Tobacco spokesperson said.
A spokesperson for Philip Morris International Inc., which does not sell e-vapor products in the U.S., said manufacturers must put their products and scientific evidence packages before the FDA for review to best address questions about new nicotine-containing products and guard against youth use. In April, the FDA cleared Philip Morris's electrically heated tobacco product, IQOS for sale in the U.S.
Trump's push for a ban on non-tobacco flavored vaping products comes after reports of six deaths and over 450 possible cases of illnesses associated with the use of e-cigarette products.
Investigators have not linked a specific substance or e-cigarette product to all the cases of illness. Many patients have reported using vaping products containing cannabinoid products like THC, according to the U.S. Centers for Disease Control and Prevention.
On Sept. 4, Michigan began the process of implementing a statewide ban on the sale of electronic cigarettes in response to the growing concern over vaping.
"We have a problem in our country," Trump said Sept. 11 at the Oval Office. "It's a new problem. It's a problem nobody really thought about too much a few years ago, and it's called 'vaping' - especially vaping as it pertains to innocent children."
