Recent proposed updates to the FDA's tobacco policy -- including the regulation of e-cigarettes and flavored products -- taste weak to the AAFP and 35 other medical and health organizations.
That's the message of an April 30 letter(31 page PDF) the Academy signed on to along with a coalition that includes the Campaign for Tobacco-Free Kids, the AMA and the American Academy of Pediatrics. It calls on the FDA to take stronger action to prevent the use of tobacco products by youth, including more vigorously enforcing existing rules.
High among the problematic aspects of "Modifications to Compliance Policy for Certain Deemed Tobacco Products," published March 14(www.govinfo.gov) in the Federal Register, is a delay of the regulatory compliance date for e-cigarette manufacturers. The draft guidance's revised date of Aug. 8, 2021, would allow thousands of products to enter or remain in the marketplace for more than two years without FDA review.
That gap is substantial, given that the FDA itself has characterized U.S. teen tobacco and e-cigarette use as "epidemic." Data from the 2018 National Youth Tobacco Survey(www.fda.gov) show that e-cigarette use among high school students increased by 1.5 million between 2017 and 2018.
- An April 30 letter from the AAFP and 35 other health groups asks the FDA to reconsider draft guidance regulating e-cigarettes and other products.
- The letter says stronger regulation would better address the epidemic of U.S. teen tobacco and e-cigarette use.
- The draft guidance "falls short of the forceful action needed to address a public health crisis of this magnitude," the letter says.
That staggering rise is due in large part to JUUL and similar electronic nicotine delivery system products. The devices lure users with kid-friendly flavors(www.tobaccofreekids.org) and exceptionally well-calibrated marketing -- tactics the FDA's draft guidance acknowledges.
The FDA, says the letter, already has the authority "to prevent an epidemic of use by youth, while still permitting the development and sale of medical products that promote smoking cessation."
But full exercise of that authority was not on display in the draft guidance, which, the letter says, "falls short of the forceful action needed to address a public health crisis of this magnitude."
This is partly because the draft guidance doesn't restrict menthol- and mint-flavored e-cigarettes as it does other flavors -- special treatment, the letter points out, that "has no public health justification and leaves widely available products that the latest survey data show are commonly used by youth."
The FDA posits that mint- and menthol-flavored electronic nicotine delivery systems "may be important to some adults who seek to use specific ENDS products to cease combustible tobacco product use." But this assertion is not backed by data, the letter notes.
And, flavors notwithstanding, a 2018 report(nationalacademies.org) from the National Academies of Sciences, Engineering and Medicine concluded that "there is limited evidence that e-cigarettes may be an effective aid to promote smoking cessation."
"The possibility that adults prefer these (mint and menthol) flavors more than young people, even if true, in no way establishes a public health benefit from their continued easy availability -- especially while menthol cigarettes remain on the market," the letter says. "By contrast, the data strongly establish that mint- and menthol-flavored products are contributing to the appeal of these products to adolescents."
Teen use of menthol- and mint-flavored e-cigarettes rose from 42.3% of e-cigarette users in 2017 to 51.2% in 2018, according to the CDC.(www.cdc.gov)
In March, (then) FDA Commissioner Scott Gottlieb, M.D., said the agency would take new steps toward enforcing its Youth Tobacco Prevention Plan.(www.fda.gov)
But Gottlieb has since departed the agency, leaving behind uncertainty(khn.org) about several fronts in the fight against youth smoking.
One such front the April 30 letter addressed is flavored cigars, which Gottlieb said last year(www.fda.gov) "should no longer be subject to the extended compliance date for premarket authorization -- regardless of the location in which the products are sold."
But the draft guidance "leaves untouched many flavored cigars that were on the market as of Feb. 15, 2007," the letter points out, calling on the FDA to "move with expedition to take flavored cigars off the market."
The coalition's letter also questions the FDA's plan to seek answers from the industry that's the source of the epidemic.
The draft guidance, the letter says, "touts the FDA's solicitation of solutions from the manufacturers of the top five e-cigarette manufacturers, yet these manufacturers are the cause of the problem." The agency, it adds, "must assert its own authority and not rely on voluntary action from manufacturers to achieve the FDA's public health mission."
Similarly, the letter charges that the draft guidance won't curtail the marketing of ENDS to young people.
"As a recent Stanford University study(jamanetwork.com) shows, JUUL was launched with social media and other advertising using images that overtly targeted young people and, indeed, mimicked the imagery long used by cigarette companies to appeal to youth," the letter says, urging the FDA to extend the marketing restrictions faced by cigarette manufacturers to e-cigarettes, as well.
"Unless there are comprehensive limitations on marketing, youth will continue to be exposed to tobacco marketing," the letter says.
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