The FDA has begun to start rejecting the market applications for flavored vape juice with regulators signaling full flavor ban to "save the youth".
FDA Rejects Vape Flavors
The Pre-Market Tobacco Product Application (PMTA) deadline for applications ended on September 9 2020. The FDA application process allowed the products to remain on the market for 1 year pending the approval process for the products, a deadline for approval or denial is fast approaching.
Over 500 companies filed applications for over 6.5 million different products of which 4.5 million have been dismissed for application requirement failures.
The FDA has recently started issuing the decisions for the approximately 2 million remaining market applications and so far it has only been marketing denial orders (MDOs) which require the products to be pulled from the market immediately.
August 26, 2021 the FDA released a press release that has gained wide attention from all quarters of the vape community.
The press release for the rejections of applications for three companies is actually what amounts to an official statement regarding the long sought after political decision to ban flavored vape juice (other than tobacco flavor) under the guise of "science-based regulation".
August 26, 2021 the FDA issued a press release that has gained wide attention from all quarters of the vape community as well as celebrations and increased pressure from the anti-vaping groups.
We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.
From the market denial order press release:
The agency is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that they are “appropriate for the protection of the public health.”The products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
The agency is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that they are “appropriate for the protection of the public health.”
The products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.
Flavored ENDS products are extremely popular among youth, with over 80 percent of e-cigarette users between ages 12 through 17 using one of these products. Companies who want to continue to market their flavored ENDS products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth. The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market.
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because this evidence was absent in these applications, the FDA is issuing MDOs.The agency will continue to review other premarket tobacco applications for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. Because this evidence was absent in these applications, the FDA is issuing MDOs.
The agency will continue to review other premarket tobacco applications for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth. If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.
The applications are not publicly available and therefore we are not sure what studies have been conducted or submitted by the more than 500 companies looking to stay in business.
However, outside studies conducted by public health researchers were likely to have been included, but how could a study be designed to prove that the "potential benefit for adult smokers outweighs the significant known risk to youth"?
Hundreds of thousands of comments, including testimonials about how flavored vapes keep them from returning to smoking were submitted by the public on this very regulation just a few years ago.
Decision makers at the FDA are quite aware of scientific research regarding positive e-cigarettes and the benefits of vape flavors for ex-smokers.
classic vape quote meme
Former FDA Commissioner Scott Gottlieb, now a board member at Pfizer (maker of now recalled quit smoking drug Chantix), was fast to comment on the market denial by the FDA. The Washington Post characterized his comments as "blamed the e-cigarette manufacturers for their predicament".
Many companies had ample time, and the benefit of guidances that we issued, to provide a path toward compliance, so they could demonstrate their value as tools that could help current smokers quit combustible tobacco. Many of them chose to fight the laws Congress enacted, and the FDA, and they didn’t invest in demonstrating the public health benefits that they asserted.
15 past-Presidents of the worlds' top professional society in the field of tobacco control point out:There are 7X more US adult smokers than non-smoking teens who may be at risk of nicotine addiction.But US policies focus 100% on teens, not adults.https://t.co/XCJ54YjaHM— Charles A. Gardner, PhD (@ChaunceyGardner) August 27, 2021
15 past-Presidents of the worlds' top professional society in the field of tobacco control point out:There are 7X more US adult smokers than non-smoking teens who may be at risk of nicotine addiction.But US policies focus 100% on teens, not adults.https://t.co/XCJ54YjaHM
Charles Gardner has a ton of current research and commentary on tobacco harm reduction on his twitter page that is well worth your time.
At this point they just focused on the aspect of flavors. Not sure of the rest of it. But quite clearly the FDA is keeping to its issue of no on ramp to youth. They do not have to prove kids are using it. You have to prove that it won't be appealing to kids.— Mark Anton (@Vaporadvocate) August 27, 2021
At this point they just focused on the aspect of flavors. Not sure of the rest of it. But quite clearly the FDA is keeping to its issue of no on ramp to youth. They do not have to prove kids are using it. You have to prove that it won't be appealing to kids.
Mark Anton pointing out the impossible hurdle --"You have to prove that it won't be appealing to kids."
"The young" people (teenagers) the FDA is using to justify a flavor ban also like binge drinking until they die, drunk driving, smoking actual cigarettes, taking grandma's mystery pills, climbing on a 10 foot tall stack of milk crates and eating tide pods. What can we do about that?
.@ScottGottliebMD throwing vape companies under the bus to defend the FDA here is unconvincing. The agency itself predicted that regulatory costs would drive product exit and it didn't even release guidance on how to apply until less than a year before the court-imposed deadline. https://t.co/MgcmLfSIqe— Jacob Grier (@jacobgrier) August 27, 2021
.@ScottGottliebMD throwing vape companies under the bus to defend the FDA here is unconvincing. The agency itself predicted that regulatory costs would drive product exit and it didn't even release guidance on how to apply until less than a year before the court-imposed deadline. https://t.co/MgcmLfSIqe
The FDA also acknowledged from the beginning that "premarket tobacco applications would be significantly costlier, per product, than the other pathways for introducing new products." The system was set up such that it would be cheaper to approve a new cigarette than an e-cig.— Jacob Grier (@jacobgrier) August 27, 2021
The FDA also acknowledged from the beginning that "premarket tobacco applications would be significantly costlier, per product, than the other pathways for introducing new products." The system was set up such that it would be cheaper to approve a new cigarette than an e-cig.
If you're a vape manufacturer and/or retailer, PLEASE, PLEASE, PLEASE email the SBA & Zeller about how your business will be impacted should the FDA ban all non-tobacco flavored vapes.Ombudsman@sba.govMitchell.Zeller@fda.hhs.gov— Lindsey Stroud (@lmstroud89) August 27, 2021
If you're a vape manufacturer and/or retailer, PLEASE, PLEASE, PLEASE email the SBA & Zeller about how your business will be impacted should the FDA ban all non-tobacco flavored vapes.Ombudsman@sba.govMitchell.Zeller@fda.hhs.gov
See the thread on actionable advice from Lindsey Stroud, Director of Protect Taxpayers Consumer Center.
It's infuriating because chances are PEOPLE HAVE ALREADY QUIT USING THE PRODUCTS THEY ARE DENYING .... look i'm sorry for yelling— GrimmGreen (@GrimmGreen) August 27, 2021
It's infuriating because chances are PEOPLE HAVE ALREADY QUIT USING THE PRODUCTS THEY ARE DENYING .... look i'm sorry for yelling
Vape legend Nick Green checking in.
What science? If they're telling the truth why do they block comments. What are they afraid of? https://t.co/p2Jxdt5L2H— Marshall Keith (@MarshallKeith2) August 27, 2021
What science? If they're telling the truth why do they block comments. What are they afraid of? https://t.co/p2Jxdt5L2H