Wednesday, May 25, 2016

The FDA’s Looming Regulations on Vaping & What You Can Do

Years of speculation about how e-cigarettes would be regulated in the United States concluded on May 5, 2016, when the Food and Drug Administration finalized its updated deeming regulations, which classify e-cigs as tobacco products. This change could mean an end to vaping as we know it unless we do something to stop it. While a few years will likely pass before consumers feel the full impact of the decision, vapers and tobacco harm reduction proponents have an opportunity to advocate for sensible implementation of the new policies.

The official new deeming rules for e-cigs are available for everyone to read on the Federal Register website; however, most Americans would have difficulty decoding all of the legalese because the document makes extensive references to previous policies including the Family Smoking Prevention & Tobacco Control Act as well as the Food, Drug, & Cosmetic Act. Consequently, most of the people who make, sell, use or support e-cigs remain in the dark about what is now legal and what isn't. Organizations like Consumer Advocates for Smoke-Free Alternatives Association, or CASAA, are working with legal experts to create more reader-friendly explanations of the new deeming regulations, but below is a brief overview of the basics for now.

What the Deeming Regulations Mean for E-cigs

Most of the rules that apply to tobacco now also apply to e-cigs. The most disconcerting and controversial part of the new regulations requires all e-cigs and e-liquids made after 2007 to obtain premarket approval, which means paying for laboratory testing and hefty fees to the FDA. The catch, of course, is that there were virtually no e-cigs in 2007, so this rule has the potential to snuff out the whole industry.

The FDA Deeming Authority Clarification Act

While making sure that e-cigs are safe sounds reasonable, the new regulations seem over the top considering that everyone knows tobacco cigarettes kill millions every year yet they remain perfectly legal to sell and use. E-cig makers don't have the deep pockets that big tobacco companies do, and getting FDA approval costs hundreds of thousands of dollars, so most manufacturers will simply be unable to afford to stay in business. As a result, many vapers may fall back into smoking because they have no safer alternative.

For this reason, Rep. Tom Cole (R-OK) introduced H.R. 2058, or the FDA Deeming Authority Clarification Act, to extend the exemption clause to the date when the new rules actually take effect. The bill recently passed a House committee and will likely be voted on by Congress later this year.

E-Cig Regulations in Other Countries

Just across the Atlantic, a different conversation is taking place. Public Health England released the first comprehensive evidence-based report on e-cig safety in 2015, and it not surprisingly concluded that "E-cigarettes are around 95% less harmful than smoking." The UK's Royal College of Physicians even encourages offering e-cigs to tobacco users as a strategy for harm reduction and smoking cessation.

Action Needed From Vapers - What you can do to help

  • Send an email to support HR 2058 which could save our industry
  • Send a letter to your Attorney General to save our industry
  • Sign the petition to overturn the FDA’s ruling


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