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Will JUUL Fight the FDA or Just Give Up?

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    After months of hinting, FDA Commissioner Scott Gottlieb announced actions yesterday that he says are intended to prevent teen vaping and address the concerns the agency has about JUUL. The announcement is obviously a response to coordinated pressure from special interest groups, rather than an effort to address any real problem.

    Nevertheless, within a day, JUUL Labs responded by announcing plans to invest in programs to prevent not only underage use of JUUL, but even use by adults who have never smoked, and support for the Tobacco 21 initiative that promotes laws banning nicotine products to adults under age 21.

    It’s clear that JUUL is frightened, confused, and unsure how to respond to the coordinated attacks that have been carried out against the company. That its first impulse is to support tobacco control efforts to restrict access to JUUL and other vapor products is disturbing to many vapers. The wealthy vape company even echoes FDA language in its press release.

    The “nationwide blitz” has resulted in just 40 warning letters for underage sales violations since the beginning of March.

    “Protecting our nation’s youth from the dangers of tobacco products is among the most important responsibilities of the U.S. Food and Drug Administration – and it’s an obligation I take personally,” said Scott Gottlieb yesterday in a prepared statement.

    Gottlieb announced four steps the FDA has taken (or will take soon) to protect youth:

    1. Retail enforcement of age restrictions

      “FDA has been conducting a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes – specifically JUUL products – to minors at both brick-and-mortar and online retailers,” says Gottlieb.The “nationwide blitz” has resulted in just 40 warning letters for underage sales violations since the beginning of March. Yes, 40. In the whole country. That’s some epidemic.

    2. Taking action against online sellers without proper age verification

      FDA has contacted eBay about third-party sales of JUUL on the commerce site. They thanked eBay for its “swift action to remove the listings and voluntarily implement new measures to prevent new listings from being posted to the web retailer’s site.”

    3. Demanding answers from JUUL Labs about marketing and design

      FDA has sent a letter to JUUL Labs, requesting “documents related to product marketing; research on the health, toxicological, behavioral or physiologic effects of the products, including youth initiation and use; whether certain product design features, ingredients or specifications appeal to different age groups; and youth-related adverse events and consumer complaints associated with the products.”“Widespread reports of youth use of JUUL products are of great public health concern and no child or teenager should ever use any tobacco product,” says the letter. The agency plans to send similar letters to other manufacturers soon, says Gottlieb.

    4. Unspecified future actions
      The agency is planning “additional enforcement actions focused on companies that we think are marketing products in ways that are misleading to kids.” What that means is anyone’s guess. It may not mean anything. “I will have more to say on this in the coming weeks,” says Gottlieb.

    The FDA is also “exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth. Specifically, as part of our comprehensive plan, we intend to pursue product standards and other regulations for electronic nicotine delivery systems, such as e-cigarettes, to address known hazards and concerns, including exploding batteries and accidental ingestion.”

    Making “tobacco products” less appealing is a clear reference to flavors. The regulators are in the process of creating rules that will almost certainly include restrictions on e-liquid choices — aside, probably, from tobacco and menthol. That is what they intended to do in 2016, and there’s no reason to think they’ve changed their minds.

    The response from JUUL Labs came in a press release announcing a “comprehensive strategy” to prevent youth access to JUUL and other vapor products. The strategy is clearly something that has been thought out for longer than a day — but that may not necessarily reflect well on the vape company.

    “Building on its existing youth prevention and education programs, JUUL Labs today announced it will take additional decisive action by actively supporting state and federal initiatives to raise the minimum age to 21+ to purchase tobacco products as part of an initial investment of $30 million over the next three years dedicated to independent research, youth and parent education, and community engagement efforts,” the company announced.

    JUUL Labs will work with vape-sympathetic Iowa Attorney General Tom Miller “and a group of public officials and tobacco control individuals” to strengthen the company’s efforts to “keep JUUL out of the hands of young people.” The same group “will work with JUUL Labs to develop a transparent and effective framework for independent research focused on the scientific and societal implications of vapor products.”

    “We are already seeing success in our efforts to enable adult smokers to transition away from cigarettes and believe our products have the potential over the long-term to contribute meaningfully to public health in the U.S. and around the world,” said JUUL Labs CEO Kevin Burns. “At the same time, we are committed to deterring young people, as well as adults who do not currently smoke, from using our products. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try JUUL.”

    There’s that FDA language you never thought you’d hear from a vaping company. How will JUUL qualify purchasers? Will they do cotinine tests at the point of sale to verify recent nicotine use? Or will they trust purchasers to be already “addicted”?

    Gottlieb’s announcement and JUUL’s response are both answers to months of choreographed attacks on JUUL, culminating in the release of a study by Truth Initiative purporting to show an alarming youth “juuling” trend, and letters to the FDA from tobacco control groups and members of Congress, all announced in an orgy of publicity last week.

    The groups that are pushing Gottlieb to take action on JUUL are the usual suspects engaged in anti-vaping propaganda, lobbying, and disinformation. The Campaign for Tobacco-Free Kids, Truth Initiative, American Academy of Pediatrics, and a couple others are the groups suing the FDA to force the agency to reinstate its original 2018 deadline for vape manufacturers to submit premarket tobacco applications (PMTA’s) for their existing products.

    The study produced by Truth Initiative actually shows that 90 percent of the surveyed 15 to 24-year-olds had never used a JUUL (even one puff), and 75 percent didn’t even know what it was. But to hear them tell it, a quarter of the youth population merelt recognizing the product is evidence of a frightening epidemic.

    Do JUUL’s leaders realize that tobacco control won’t compromise? CTFK and Truth will always want more; they won’t be satisfied till the entire independent vaping industry is dead and buried, and what it built is handed over to the tobacco companies that really pay the bills. JUUL is terrified that FDA will deny their PMTA, and they should be. Matt Myers and Mitch Zeller didn’t work hard on this for 20 years just to watch it disappear because a bunch of Stanford boys built a thing.

    JUUL can play along with this youth charade and put on a show of refusing sales to adults who don’t smoke, or try to shut down juuling social media accounts, but they still won’t get to join the FDA-approved club — because they don’t pay tobacco taxes or FDA user fees. Want to make this all go away, JUUL? Sell your company to Altria. That’s what all your tormentors are really hoping for.

    If tobacco control doesn’t protect the cigarette industry, its very reason to exist will disappear, and the money that funds it will dry up. The FDA Center for Tobacco Products, Truth Initiative, American Cancer Society — and all the other small, medium and large agencies and organizations that exist to wage war on Big Tobacco or “cure the disease” called nicotine addiction — will have no purpose or support.

    They all need the tobacco industry. They have to protect it, and they are. What exactly is JUUL doing?

    http://vaping360.com/fda-response-juul-campaign/

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