In a September 12th press release, the FDA announced new measures taken against underaged vape sales. The new release highlighted that the FDA’s investigations this year have resulted in more than 1,300 warnings and fines to retailers. The focus of those communications centered around illegal sales of vape products to minors during their “blitz of brick-and-mortar and online stores,” while also requiring action from five major manufacturers regarding their plans going forward.
The FDA mentions that they “remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” but, as commissioner Scott Gottlieb puts it, “The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”
The most significant takeaway from the release was the notion that last year’s extension of the deadline for Pre-Market Tobacco Applications to 2022 may be reversed, likely resulting in tens of thousands of U.S. small businesses vanishing effectively overnight. Depending on when they mark a new date, the entire industry that had a four-year span to fight for the right to exist could cease just as quickly as it came to be.
“But in view of the accelerating use among youth we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.”
Further comment was made on the FDA’s newly released statement by none other than commissioner Scott Gottlieb. Prevalent in the statement is the word “epidemic,” which the commissioner uses “with great care.” For the nine uses of “epidemic” in the statement, and on the course correction from the deadline date, Gottlieb says “if, as we expect, preliminary data that’s in our possession and will be finalized and released in the coming months confirm our present observations that the youth use of e-cigs is rising very sharply; we’ll swiftly change course.” Gottlieb continues, “today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement blitz and that, collectively, represent more than 97 percent of the current market for e-cigs — JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.” Action is required before this unpublished data is finalized, however.
“Given the magnitude of the problem, we’re requesting that the manufacturers of these brands and products come back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the market.”
Requiring this action before hard data is available puts these companies in a tough position, but the FDA has suggestions to combat underage vape sales that border on directives.
“Let me be clear. This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements.”
Tangentially, tobacco industry stock prices jumped up on September 12th. American Vaping Association President Gregory Conley said “this move by Commissioner Gottlieb is nothing more than a gift to the tobacco industry. No one should be surprised that stocks for Philip Morris International, British American Tobacco, and Altria all shot up following the announcement.”
Conley continued to respond on behalf of the vaping industry. “Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and do not even sell the products being targeted by the FDA with threatening letters. Despite this, Commissioner Gottlieb is threatening to shut down all these businesses unless larger manufacturers unilaterally choose to change their marketing practices. It is absolutely absurd and a perversion of how regulatory agencies are supposed to approach their work.”
As part of the ongoing effort by the FDA to curb underage vape sales, they’ve also “expanded ‘The Real Cost’ public education campaign with messages focused on preventing youth use of e-cigarettes,” and “will launch a new, full-scale e-cigarette campaign targeted to youth next week.” Their “don’t get hacked” campaign can be seen now, which uses the “USB” look of the JUUL to effect, and gives a hint of what to expect with their upcoming campaign.
In response to the FDA’s preference of youth safety over adult safety, Gregory Conley had one final statement. “Vaping products are intended for use by adult smokers, not youth. However, just like with marijuana and alcohol — usage rates of which are higher among teens than vaping products — it is impossible to stop all youth from experimenting.”
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