Activism & FDA Deeming Regs

I’ll be updating this regularly, but this is what I’ve got for what’s going on with the FDA. More content is coming in the near future, but I can only type so much all at once:

This is the most current information I have on the FDA Regulations.

Big Points

  • This is about more than just us. This is for the millions of people who have yet to make the switch from cigarettes. This is about keeping loved ones around. We can’t quit on quitting.
  • The FDA Deeming Regulations are already happening. They are here. They are published in the Federal Register. They are the law of the land.
  • The FDA Deeming Regulations as they are will essentially outlaw all current vaping devices. The FDA disagrees and believes that the PMTA process will be sufficient for vaping, but the first products passed in November 10th, 2015 for a law that was passed in 2009. And the products in question had 20 years of background which our industry does not.
  • We need to stick together as an industry. Whether or not you agree with everything AEMSA, SFATA, CASAA, or whomever does, we can sort out those things later. We need to save the industry before we can perfect it.
  • There are two prongs to the strategy: litigation and legislation

      The litigation strategy is designed to disrupt the legal grounds on which the FDA are regulating the vaping industry. Such grounds include contradictory laws from the Federal Trade Commission (FTC), which would have us defrauding our customers.
      The legislation strategy is designed to create a reasonable, fair-minded, and science based regulatory structure rather than the overbearing, expensive, and unusable route provided by the FDA.

      The Cole Bishop Amendment for Agricultural Appropriations for Fiscal Year 2017 is our best bet for saving the industry.

      The Cole Bishop Amendment will move the predicate date from February 2007 to August 8th, 2016. As it stands, after August 8th, 2018 the only product allowed on the market is MAYBE one example the FDA have found. If the Cole Bishop Amendment passes, then all products that were released before August 8th, 2016 will be able to stay on the market. That means even if EVERYTHING ELSE the FDA passes stands, the industry will be able to use the drastically less expensive and rigorous Substantial Equivalence (SE) and Substantial Equivalence Exemption (SE Exemption) routes.

      As it stands after August 8th, safety issues can’t be fixed. Leaking can’t be fixed. Firmware updates can’t go out. Everything is covered and we’re left in the cold.

      But What About HR 2058?

      HR 2058 is in a standstill. It was last year’s strategy. The Cole Bishop Amendment is a much stronger with bipartisan support (HR 2058 only had Republican backing, which hampered its likelihood of getting passed tragically).

      Contact your Congressmen to support the Cole Bishop Amendment! If you’re a shop owner, tell them you will be put out of business by the current FDA regulations and that the latest scientific literature abroad and domestic (such as the Royal College of Physicians finding vapor products to be 95% less harmful than cigarettes)

      The Players

      All these organizations are involved in the fight for reasonable reglations:

      • AEMSA is the American Eliquid Manufacturing Standards Association.
      • AVA is the American Vapor Association and are frequently up to date and providing lots of necessary information.
      • CASAA is the Consumer Advocates for Smoke-free Alternatives Association. If you’re not a member, be one now. It’s free and they work on the state and federal levels.
      • Right 2 Be Smoke Free started their fight in Indiana and are leveraging their expertise by heading up the litigation against the FDA.
      • SEVIA USA are the Shenzhen Electronic Vapor Industry Association USA. They are a trade group representing Innokin, Kangertech, Aspire, Smoktech, Joyetech and iJoycig with new members coming in all the time. They are funding and supporting various advocacy groups with their reach.
      • SFATA represent the retailers and manufacturers of the industry. They have state-based chapters to organize at that level and a national level to fight in DC. If you are a retailer, modder, or manufacturer these are the guys to talk with.
      • VTA are the Vapor Technology Association and are focused on public perception, safety, and policy.

      How can I stay updated?

      • Check out Smoke Free Radio.
      • Follow the above groups on Twitter, Facebook, sign up for their emails. That is the easiest way to stay involved.