FDA Deeming Regulations Announced and Our Initial Thoughts

Information on the FDA deeming regulations and how it will affect vapers, vendors and manufacturers.

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FDA Deeming Regulations
FDA Deeming Regulations

Vaping 360 FDA Deeming Regulation Coverage

We are working very hard to digest the mammoth 499 page FDA deeming regulations document just released this morning (05/05/2016).

We will be releasing separate articles once we have thoroughly worked through this document on how the regulations will affect average vapers, vendors and manufacturers. This page will be updated today and over the next few days and weeks to help direct you to any useful information about the deeming regs. For now please read our initial thoughts further down the page.

Quote from Alex Clark of CASAA:

“Please keep in mind that this is not the end of the process. CASAA will continue to focus our efforts to develop sensible regulation of vapor products that will have maximum benefit to consumers. The most important thing to remember is that consumers will continue to have access to the wide variety of vapor products for a period of time before the regulations take effect. But, for now, vaping as we know it will continue and we are not done by any means. Keep calm.” 

Link to Full FDA Deeming Regulations Document

Important Follow-Up Content

Our Initial Thoughts and Key Findings from the Deeming Regulations

Many vape advocates have warned about the coming of this ominous day, and now it is here.

The US Food and Drug Administration announced its long-awaited rule that deems vapor products (along with cigars, pipe tobacco, hookah and others) to be tobacco for purposes of regulation under the Family Smoking Prevention and Tobacco Control Act. The final rule is similar to the version announced in 2014.

Our Key Findings

The rule has parts that will go into effect 90 days after publication, and others that are staggered over the next two years. Provisions that take effect in 90 days include:

  • No sale of deemed products to people under 18, in person or online, with age verification required
  • No distribution of free samples
  • No vending machine sales

Manufacturers will have to apply for permission to sell products that were not on the market as of Feb. 15, 2007 (the “grandfather date”), and prove that they meet stringent requirements that include being beneficial to the public health as a whole. Most in the vapor industry think that is a standard that can’t be met.

According to Dr. Michael Siegel, writitng today in his blog, “To demonstrate that a product is beneficial for the public’s health, the manufacturer will have to consider not only the risks and benefits to smokers, but the risks and benefits to non-smokers (including youth) and former smokers. Manufacturers will have to demonstrate not only that the product is safer than cigarettes, but that it is effective for smoking cessation and its cessation benefits will not be outweighed by uptake of the product by nonsmokers, including youth.”

Under the newly announced rule, manufacturers will be able to continue to sell a product for up to two years before submitting a pre-market tobacco application (PMTA), and another year as the application is considered. The FDA estimates as many as 5,000 hours of work will be required on applications, along with expensive laboratory and legal analysis. Most analysts estimate a cost per application of over $1 million. Each item being sold requires a separate application, including each flavor and nicotine strength of e-liquid. There is no guarantee that an application will be approved.

Additionally, all manufacturers, retailers and importers of newly deemed products will also now be subject to the other requirements listed in the Tobacco Control Act, including:

  • Registering manufacturing facilities
  • Providing product listings to the FDA
  • Reporting ingredients to the FDA, including harmful and potentially harmful constituents
  • Placing health warnings on packages

Unanswered Questions

There are still huge questions about the regulations, and many people are reading them closely to understand:

  • Though the FDA is not banning e-liquid flavors now, do they intend to?
  • How will they be able to regulate all the parts and components of vapor products?
  • Will products that contain no tobacco-derived nicotine be included?

Is This the End? How Can Vapers Fight Back?

The deeming document is almost 500 pages long and full of complex legal language. It will take time to properly analyze all the details. From a first skimming of the rule, though, it is probably fair to say that the FDA intends to wipe out the independent vapor industry. According to Dr. Siegel, “the prediction that vaping products could produce a public health miracle – decreasing tobacco cigarette consumption by 50% in the next decade – has been extinguished by the FDA.”

But there are still ways to prevent the decimation of vaping as we know it. It may come down to legal challenges, in which case manufacturers and retailers will file lawsuits on various grounds to prevent the deeming regs from being implemented. That may take years, and would likely postpone much of the regulation during the legal process. But first, there are still two legislative possibilities to change the grandfather date for vapor products.

HR 2058, the “Cole bill” would change the date to the present and allow modern vapor products to be sold without requiring FDA approval. The bill is alive and in need of co-sponsors in the House of Representatives. CASAA has a Call to Action that provides vapers (and their friends and families) to send a pre-written letter of support for HR 2058 to their members of Congress. The process takes less than a minute to do and can have a huge impact on the bill. This is job number one for any vaper reading this.

Second, much of the HR 2058 language has been included in the House appropriations bill that is now working its way through Congress. It is important that vapers stay aware of these legislative efforts, and remain active in contacting elected representatives when needed.

It’s Bad, but Let’s Not Panic

It may sound silly at this frightening moment, but we should also say, don’t panic. As the regulation is analyzed and people in the industry develop strategies to fight back, vapers need to discuss this with friends and family, work to make others aware of the challenges ahead, and stay committed to the thing that has helped us all improve our lives so much.

Quotes and Comments from Others

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Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Christian Garnir

    Happened here in Belgium mid march, lucky for us they had to redrew this ‘stupid’ article again after 1 month for review. The next one wil be less rigorous, i hope.
    In fact, we all are forced to these abiding European laws in the near future.
    Tobacco companies rule the world apparently, they make me sick in so many way’s..

  • Damon Watts

    this is big tobacco lobby money at work. all this will do is make a blackmarket for it. when will america learn that you cant control every aspect of peoples lives. look how well their war on drugs has worked. there are my users and drugs then ever.

  • Michael Abrams

    Let’s recognize this for what it is, a money grab under the guise of save the children plus misc bullshit, in 500 pages of legalese. How many pages were in the ACA, as a comparison?

    As long as big oil, banking, insurance, pharm, tobacco, and other big lobbies can buy votes, there will be severe impact on innovation and small business.

    Altria and RJR can afford the studies, and Marlboro juice from the gas station is easy to tax and regulate. Do you want Red or Menthol juice today, Mr. Kendell?

    I am in a second non related industry that is facing the same, in the past 4 years. Then add health care costs, mix, and it all went boom, like a mech in the hands of an underage fool.

    Sorry for the political rant. I think this is a symptom of bigger problems in the US, each party plenty guilty. No remaining balance between corporate greed and over regulation, and this can impact us in terrible ways, both short and long term.

    Honorable mention goes to the media. Thanks for reducing our information to 60 second twisted sound bytes, that for whatever reason, are believed by a different, but sizeable group of fools.

    Like captain of the Titanic, you can keep turning the wheel, but not fast enough to miss the tip of the iceberg.

  • Edward Heusser

    While I totally agree that this legislation is stupid, I mean, I believe that vaping is clearly better for for the user and those around them but why should it have to be proven to be BETTER, rather than just no worse? Anyway, there is one point that is a ray of light here. A company is allowed to sell a product for 2 years before submitting this ridiculous application (PMTA) At the moment the technology is moving so fast that new mods come out all the time. I’d expect that many that were made 2 years ago aren’t being sold any more. I’d expect competition will cause innovation to continue in this way and innovative manufacturers wont ever need to apply. Under this legislation the only companies that will suffer are those who sell cheap, outdated mods. The exception here of course is if a mod happens to be so well designed that people are favouring it even 2 years after its first release but either it could be ‘evergreened’ (Changed in a minor way and re-released as is done to refresh a patent restriction) Or at this point the company decides its worth paying a million to keep selling. Same with the juices really, but I think it is worse ’cause I could see a juice being good enough to be popular after 2 years.

    So I don’t think its gonna matter so much and in fact will enforce innovation and therefore drag standards at the lower end of the market up. Am I right with this or did miss something?

    • Jim McDonald

      Well, you’re assuming any application will be approved. As the regs are written, the standard for approval cannot be met. Manufacturers must prove that their products are a “benefit to the overall public health.” That means they benefit everyone — not just smokers or vapers, but the entire population. How can that be proven? It can’t.