FDA Deeming Regulations Announced and Our Initial Thoughts

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

    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

    Jim McDonald
    Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy