September 9, 2020 was the PMTA deadline. A year later, the vape industry is still trying to parse the regulations and communication from the FDA. The FDA has been mum about what products will have final approval. While the eJuices.co team has kept their ears to the ground on what the FDA will do about flavors, we have always run into more questions than answers. How is PMTA doing one year later? Will flavors actually go away? What does this mean for your business? The eJuices.co team will try to answer these questions in our latest State of Vape.
Will Flavors Go Away?
The FDA’s recent actions have indicated that approval will be difficult. With the rejection of four million PMTAs, one would think that the FDA and the Center for Tobacco Products (CTP) in particular would quickly review the rest of the products. However, the FDA themselves have admitted that the likelihood of reviewing all the products before September 9, 2021 was extremely low. As of this writing, no products have final approval from the FDA.
The rejection of 55,000 flavored vape juices on August 26 (around 2% of the remaining 2 million products) is the first outright rejection of vape juice products from the FDA since they received marketing denial orders (MDOs). MDOs indicate that these products cannot be introduced or reviewed for interstate commerce, and if they are already on the market, they must be removed from the market or risk enforcement actions.
“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,” said Mitch Zeller, director of the CTP.
Zeller further reminded vape manufacturers that the industry must provide evidence that their products protect public health. “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.”
CTP-Funded Research Shows That Flavors Work
The fact that Zeller is asking vape manufacturers to prove that their products protect public health may be dubious considering that Zeller himself has admitted, according to Vaping360’s Jim McDonald, that smokers smoke for the nicotine but die from the tar. This tar is not present in alternative nicotine products such as vape juice. The CTP has even funded research that concluded that flavors are a form of harm reduction. The same research also concluded that rates of youth smoking might actually increase if flavors were banned.
Funding such research means that the CTP may want to re-evaluate its position on flavored vape juice. Many smaller companies rely heavily on flavors for revenue. One of the three companies that received an MDO already announced that they would re-launch their products with synthetic nicotine, which is not regulated by the FDA as of this writing (the Tobacco Control Act only regulates nicotine derived from actual tobacco). Many other vape manufacturers have also switched to using synthetic nicotine as well.
What This Means For Your Business
Vape shop owners should consider increasing the offerings of vape juice made with synthetic nicotine. While there might not be an immediate decision on September 9 itself, the FDA and CTP have sent mixed messages through their words and actions which may confuse vape shop owners. It could also be possible that the deadline could be extended again considering the current FDA commissioner is only there in an acting capacity and that the FDA has admitted that it was highly unlikely that they would be able to review all vape products before the deadline.
The eJuices.co team will definitely update you on anything PMTA related. If you have any further questions, comments, or concerns, you can always contact your eJuices.co account manager or sales representative. We’re looking forward to speaking with you and helping your business succeed.