America’s Flavour Crisis

Posted 9th January 2020 by Dave Cross
The Trump administration leaked news of a flavour restriction on New Year’s Eve, and the full announcement came last week. It gives companies a 30-day notice to cease manufacture and sale of flavoured pods. Open system juices escape this Food and Drug Administration (FDA) order, but remain under threat with the impending Premarket Tobacco Product Applications (PMTA) May deadline.

Once the thirty days are up, tobacco and menthol will be the only pod-based flavours available to American purchasers as a result of the FDA hiding behind the teen epidemic hype and enforcing the Deeming Rule.

HHS Secretary Alex Azar said: “The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally.”

“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary.”

“Companies that do not cease manufacture, distribution and sale of unauthorized flavoured cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions” - FDA

FDA Commissioner Stephen Hahn added: “As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavoured e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities.”

Any manufacturer wishing to continue to supply other flavours to the market for open systems will have to submit their PMTA application by May 11th – and pay the excessive, crippling fees associated with that. Any product not having a PMTA submitted by this date will become illegal for sale on May 12th.

Anti-vape organisations still aren’t happy. Erika Sward, a spokeswoman for the American Lung Association said: “Flavours attract kids, and menthol is a flavour. It really helps to numb the senses and makes the poison go down easier.”

CDC principal deputy director Dr Anne Schuchat said the organisation didn’t believe flavours played “a critical role” in adults switching away from smoking and that menthol and mint should be included in the ban.

Related:

  • FDA finalizes enforcement policy on unauthorized flavoured cartridge-based e-cigarettes that appeal to children, including fruit and mint – [link]
  • PMTA Guidance – [link]


 Dave Cross
Article by Dave Cross
Freelance writer, physicist, karateka, dog walker