The U.S. Food & Drug Administration (FDA) has accused two e-cigarette manufacturers of reneging on a promise to help curb vaping among children and teens.
In September, the FDA threatened to ban flavored nicotine pods in response to a sharp rise in e-cigarette use among minors. A month later, JUUL Labs, Altria, Inc., and several other manufacturers provided the agency with detailed plans for reducing youth vaping.
Altria, for example, agreed to stop selling nicotine pods until the problem had been adequately addressed or it received the FDA’s permission to resume sales.
For its part, JULL promised to alter its advertising campaigns and limit the sale of flavored nicotine pods to its website, which utilizes an age verification system.
Pod-based e-cigarettes are favored by children and teens, and most experts agree that such devices are the driving force behind the recent sharp rise in vaping by minors. In fact, JUUL’s flavored pods are particularly popular among teenagers and now make up more than 70% of the e-cigarette market.
On December 19th, Altria announced it would acquire a 35% stake in JUUL for $13 billion.
As part of the deal, Altria committed to significantly expand the market for JUUL’s products by giving the San Francisco-based startup access to more than 230,000 retail outlets that sell its Marlboro cigarettes and other tobacco brands. Right now, JUUL e-cigarettes are sold in just 90,000 stores.
In addition, Altria will include JULL’s advertising inserts in its cigarette packets.
Finally, the deals grants JUUL Labs access to Altria’s well-funded lobbying machine and experienced government relations experts. Those resources will greatly aid JUUL’s efforts to shape public policy in regards to e-cigarettes.
According to the New York Times, none of this is sitting well with FDA Commissioner, Dr. Scott Gottlieb.
“JUUL and Altria made very specific assertions in their letters and statements to the FDA about the drivers of the youth epidemic,” he told the Times. “Their recent actions and statements appear to be inconsistent with those commitments.”
Among other things, Dr. Gottlieb said he was working on a letter critical of the companies’ conduct. Top executives at JUUL and Altria should also expect an invitation from the FDA Commissioner.
“I’m reaching out to both companies to ask them to come in and explain to me why they seem to be deviating from the representation that they already made to the agency about steps they are taking to restrict their products in a way that will decrease access to kids,” he added.
In November, the FDA proposed new restrictions aimed at reducing youth vaping.
Among other things, the proposal would require retail stores to limit the sale of e-cigarettes and other vaping products to age-restricted areas that aren’t visible to minors.
According to The New York Times, the FDA will likely release guidelines for those restrictions right around the time Dr. Gottlieb meets with JUUL and Altria executives.