Throughout 2018, the U.S. Food and Drug Administration (FDA) has been concerned with the increasing use of e-cigarette products among America’s youth. As the situation has continued to escalate, so has the FDA’s efforts to curb the situation, including new regulations and enforcement in both the retail and manufacturing level. As the year comes to a close, the FDA is far from letting up on the e-cigarette industry and in a new press release, Gottlieb states plainly that “all options are on the table” and that the entire e-cigarette industry can expect the FDA to take new steps toward addressing youth use of e-cigarettes “in the coming weeks.”
The FDA has a new action plan that it plans on releasing by mid-November that it says will set new forceful steps that will confront and reverse the youth addiction trends that are “at epidemic levels.” The FDA had asked five manufacturers–including JUUL Labs, Inc., Reynolds American Inc., Altria Group Inc., Fontem Ventures and Japan International Inc.–to submit plans to help address youth access to e-cigarette products and youth addiction to these products. As for what’s to come, Gottlieb’s comments hint at heavier regulation and some products being pulled from the market.
Gottlieb described meetings he had with several manufacturers and described them as “constructive.” He said that the companies acknowledged the health consequences associated with youth use of tobacco products and described their proposals addressing the issue as “thoughtful.” These plans not only outlined steps each company planned to take but also allegedly included suggestions for steps that the FDA should take to make e-cigarettes less appealing to youth. Gottlieb said that some companies explicitly stated that preventing youth was a priority and that benefits presented by e-cigarettes to adults couldn’t undermine efforts to address the growing issue e-cigarettes present youth.
Flavors were named as a factor contributing to youth appeal, and also in helping adults attempting to cut back on using combustible tobacco products. Other suggestions or plans that came from these meetings allegedly included restricting the sale of e-cigarettes to channels that have stricter age restriction practices and completely removing products from the market until they have premarket authorization from the FDA. While this may seem like an odd proposal, it is what Altria Group confirmed in a recent press release announcing it would be pulling some of its e-cigarette products from the market [read more here]. Another proposal? Raising the minimum age to purchase tobacco to 21 years of age on a federal level. This has been a trend in local governments for some time, so it’s not surprising tobacco 21 is being proposed on a national level. This was another recommendation that Altria Group Inc. confirms it discussed and supports in its recent press release.
While the FDA is still accepting public input on the e-cigarette matter and it claims all options are on the table, the announcement that new actions can be expected by mid-November brings into question the FDA’s willingness to come up with a comprehensive, business-friendly plan with a wide range of input and opinions. “Achieving the right balance requires a strong regulatory process that protects our nation’s youth,” writes Gottlieb, soon after referring to the e-cigarette situation as a “public health tragedy” and that it’s given ample warnings of the growing trend, as if laying the foundation of an argument for what’s to come in the next few weeks.