Trump’s proposed vapor ban leaves industry in state of turmoil, confusion

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September 12, 2019

Banning flavors for vapor
products will send consumers to the black market. Even worse, a ban could send
some vapers back to deadly combustible cigarettes. This was the consensus of
several vapor organizations and tobacco harm-reduction health groups after
President Donald Trump announced his intent to ban all flavored vapor products
except for tobacco on Wednesday.

Katherine Mangu-Ward, the editor-in-chief
of Reason magazine, probably stated it best when she tweeted “My god.
The intense stupidity of this logic: 1) Black market vape cartridges made
people sick, so, 2) let’s pass a bunch of regulations to push more popular
types of vape cartridges into that same black market; 3) Lives will be saved! Wait,
no. THAT WON’T WORK AT ALL. Argh.”

Alex Clark, CEO of The Consumer
Advocates for Smoke-free Alternatives Association (CASAA), a vapor industry
advocacy group, said in a statement that removing vapor products from the
market and prohibiting the sale of nicotine vapor products in flavors other
than tobacco will “inevitably lead to the creation of a massive, unregulated
underground market” that exposes consumers to dangerous and unnecessary risks.

“Flavored vapor products were
developed by consumers who wanted better quality and more effective
alternatives to smoking,” Clark wrote. “That grassroots entrepreneurship and
innovation is at the core of the vaping community and the industry it supports.”

Tony Abboud, head of the Vapor
Technology Association (VTA), a vapor advocacy group, wrote in an email that flavored
vaping products are one of the most effective smoking cessation tools on the
market.

“A study by the New England
Journal of Medicine found that vapor products are nearly twice as effective at
helping adults quit smoking than any other nicotine replacement methods like
the patch or pill,” Abboud wrote. “Not only that, but the Royal College of
Physicians and Public Health England have reviewed all the peer-reviewed
research and concluded that nicotine-vapor products are at least 95% safer than
cigarettes. There has been no indication that industry standard
nicotine-containing vapor products are to blame for recent cases of lung
illness. In fact, FDA investigators found that cannabis or THC products were
likely the cause.”

Other countries are weighing in
as well. Doug Mutter,
compliance director at VPZ, the largest vapor retailer in the UK, wrote in an
email that Trump’s plans “do not make any sense and will mean that millions of
Americans will be forced to choose between smoking again and turning to
products on the black market.”

Mutter states that while Trump
has rightly called for tighter controls and regulation of the US vapor industry,
because there is no strict testing and regulation landscape in the US, “vaping
is already proving to be a key weapon in the UK’s stop smoking strategy and is
bringing momentum to the country’s ambition of becoming smoke-free by 2030.”

On Sept. 11, President Trump,
Health and Human Services Secretary Alex Azar, and Acting Food and Drug Administration
(FDA) Commissioner Ned Sharpless announced the intention of the Trump
Administration/FDA to take additional action against flavored e-products. The
FDA has had the authority to ban vaping flavors since 2016, however, the
regulatory agency has previously resisted calls to take that step.

In a separate announcement,
Acting Commissioner Sharpless announced that in the coming weeks the FDA’s
Center for Tobacco Products would look to clear the market of flavored e-liquid
via market authorization requirements based on preliminary results from the
National Youth Tobacco Survey showing continued utilization of flavored
e-products by youth.

Trump’s first public comments on
vaping come as health authorities investigate hundreds of breathing illnesses
reported in people who have used e-cigarettes and other vaping devices. No
single device, ingredient or additive has been identified, though many cases
involve marijuana vaping. The restrictions announced by Trump officials would
only apply to nicotine vaping products, which are regulated by the FDA.

Several vapor retailers have
expressed frustration over the flavor ban and place the culpability for the
rise in youth vaping on small, easily concealed vaporizers and at least one
former federal regulator agrees, going as far as to blame a specific product.

Scott Gottlieb, who stepped down
as FDA commissioner in April, wrote in a tweet that one company, Juul Labs, bore
particular responsibility for forcing the administration’s hand. “Unfortunately,
the entire category of e-cigs was put at risk largely as a result of the youth
abuse of mostly one manufacturer’s products,” Gottlieb wrote.

On Monday, the FDA issued a
warning letter to Juul Labs for marketing unauthorized modified risk tobacco
products by “engaging in labeling, advertising, and/or other activities
directed to consumers, including a presentation given to youth at a school.”

The agency also sent a letter to
the company expressing concern, and requesting more information, about several
issues raised in a recent Congressional hearing regarding Juul Labs’ “outreach
and marketing practices, including those targeted at students, tribes, health
insurers and employers.”

This is what is currently
known about the planned vapor flavor ban:

  • Preliminary numbers from the National
    Youth Tobacco Survey show increases in the number of youth reporting use of
    e-cigarettes overall (based on reported use in the last 30 days): climbing from
    21% in 2018 to 27.5% in 2019. Additionally, the survey indicates an increase in
    youth use of mint/menthol flavored e-cigarettes, rising from 51% in 2018 to
    63.9% in 2019.
  • CTP will, in the coming weeks, issue
    revised compliance policies concerning enforcement of the August 8, 2016
    deeming regulations regarding all ENDS products except non-flavored and
    tobacco-flavored products.
  • If CTP follows through with the policy
    revision outlined in Commissioner Sharpless’s statement, in the coming weeks,
    CTP is likely to rescind enforcement discretion for ENDS products concerning
    provisional Premarket Tobacco Product Applications (PMTA) that have a
    characterizing flavor other than tobacco. This will effectively ban flavored
    ENDS products unless there is a product on the market that has a PMTA
    authorization.
  • Commissioner Sharpless’s statement
    contained a further warning for tobacco-flavored ENDS products: if future
    survey data indicates a migration of youth consumption patterns to tobacco
    flavored products, CTP will take additional action.
  • Action threated by CTP follows on a
    warning delivered by FDA’s previous commissioner, Dr. Scott Gottlieb, following
    2018’s announcement of a revised enforcement policy for flavored ENDS products
    sold in unrestricted retail establishments. In that announcement, Dr. Gottlieb
    indicated that FDA will take further action should the survey data show
    continued increases in youth consumption.
  • In recent weeks FDA has faced mounting
    pressure from civil society and Congress (on a bi-partisan basis) to take
    action to address vaping issues. This pressure comes on the heels of media
    reports concerning young people falling ill or passing away due do
    complications experienced following vaping. Administration officials outside of
    FDA have expressly linked the Administration’s focus on this issue to these
    deaths and illnesses.

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Source: VaporVoice