E-Alternative Solutions announced on July 8 that the FDA has accepted their PMTA submission for substantive review.
That means that the applications meet the basic expectations for a PMTA submission, and will now be thoroughly examined by FDA staff. It is not a guarantee that the company's marketing application will be approved.
The products that were submitted to the FDA that are currently on the market will be allowed to remain in stores for one year while the FDA reaches its decision, unless the agency decides to reject them before the year is up.
E-Alternative Solutions (EAS) has submitted Premarket Tobacco Applications for its closed-system vape products to the FDA. The company is the first vaping manufacturer not owned by a major tobacco company to announce a PMTA submission. All of the big tobacco companies that sell vaping products in the U.S. have submitted applications, the most recent being Imperial Brands’ application for myblu.
The EAS PMTAs submitted were for the company’s Leap device and pods and its Leap Go disposable product. Leap products are primarily sold in convenience stores, and are designed to compete with popular pod and disposable products from JUUL, NJOY, and similar tobacco industry products. EAS also sells a line of CBD products.
Since the FDA’s January 2020 guidance prohibiting sales of prefilled pods in flavors other than tobacco and menthol, EAS suspended its sales of fruit- and candy-flavored Leap pods, although it continues to sell the disposable Leap Go in mint and mango flavors. The company has submitted all of its flavors for FDA approval. But because only currently marketed products may remain on sale after the Sept. 9 PMTA submission deadline while the agency reviews the application, the candy and fruit Leap pods will remain unavailable until (and if) the PMTA is approved.
The Leap pods have all been submitted in 2.4 and 4.8 percent strengths. The Leap Go devices are only available in 5 percent. According to EAS, these are the flavors the company submitted to the FDA:
According to EAS, the PMTA included more than 108,000 pages of testing results and analysis, including toxicology, behavioral studies, and an extensive review of existing literature of vapor product science. The company also studied abuse liability, and performed a risk assessment of its products.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable FDA to conclude these products are appropriate for the protection of public health,” said EAS vice president and general counsel Chris Howard.
“From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith,” Howard added. “Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”
A company able to spend the millions it takes to submit a viable PMTA has to be optimistic about the future, as EAS is. But there is no assurance the FDA will approve any independent company’s PMTA submission. And even if the agency does approve applications from some small closed-system manufacturers like EAS, it’s questionable whether any open-system devices or bottled e-liquid will ever make the cut.
The E-Alternative Solutions products, if approved, will be sold in c-stores, not vape shops. E-liquid and open-system hardware manufacturers, however, need vape shops to survive as outlets to market their products. And vape shops will not survive unless a wide variety of e-liquid flavors and devices are available. It’s unlikely the FDA will approve enough open-system products and e-liquid flavors to allow vape shops to prosper.
The streamlined PMTA promised in January by Health and Human Services Secretary Alex Azar has never materialized—and it looks like it never will. With no changes to the process that make it fair or affordable for small businesses, thousands of vape manufacturers will be left twisting in the wind when the Sept. 9 PMTA deadline rolls around.
Given current FDA requirements, it is not just “questionable” that any open source system or e-liquid will be approved by the FDA – it is impossible. Let’s say I have an e-liquid that I’m determined to get approved (and I have multiple millions of dollars to spare). Since that e-liquid can be used in many different systems, the FDA says I must submit testing on a “reasonable” number of systems. But what is ‘reasonable’? Who knows – the FDA has never defined it. But let’s say they define ‘reasonable’ as five different systems. Which systems do I use? No open… Read more »
Yes, we have discussed this problem before. I tend to agree with you. However, a lot of well-respected industry people believe the FDA will approve some e-liquids. I suppose we’ll all find out pretty soon.
At Regulatory Compliance Experts, we don’t believe the PMTA submission requirements are any more ominous than any other drug, device, or biologics products. E-liquids can be mixed and validated through already mandatory product and ingredient listings. The key will be substantiating all supporting bibliographies for the overwhelming benefits of vaping products (both open and closed) over combustible cigarettes with the evidence of retail and manufacturer training to avoid underage access, sales and use. Reply with questions!?!
You’re a tobacco regulatory compliance expert? If so, I’m surprised you don’t believe that the unique public health test applied to tobacco products makes any vaping submission to the FDA a lot more difficult than the other products you mentioned.
Yes!! I’ve been hoping that they had the money!! Ive been loving my leap this company has good e-liquid and pricing theyre way cheaper then juul on the device and pods also the pods hold 2x the amount of a juul pod. I was kind of amazed because I went to start draging on mine right as I realized this article was about the device I was currently using