Wed. Jul 8th, 2020

FDA Receives the First PMTA Submission

The FDA recently received the very first Premarket Tobacco Application (PMTA) from a tobacco company, Reynolds American Inc and also known as RJ Reynolds. They submitted the PMTA for an e-liquid based product.

Multiple products are covered in the application, which includes several flavors in the Vuse Solo category. The RJ Reynolds spokesperson mailed information about the application. It is a cigarette-like device, which has prefilled cartridges. The Solo is the oldest product.

British American Tobacco (BAT) now owns the RJ Reynolds, they sell tanks, pod-based vaping products, and several flavors, they sell them under the Vuse brand in the U.S. also the company is popularly known for the Newport, Camel and Natural American Spirit cigarette brands.

American Vaping Association President George Conley mentioned the sad reality and the problem faced by the vaping business owners. He said, “This is really sad to know that only a successful cigarette selling company, that also deals in vape products can go through the complicated process of the American tobacco regulatory system. The rest of the vaping industry cannot afford to follow the procedure, neither can they sell billions of dollars of cigarettes to cover up the business. The regulations are stressful for them, as it is only focused to put them out of business.”

There is nothing clear as to why Solo was chosen as the first product to be submitted to the FDA. Maybe because it is the oldest product in the market and hence, more research is available for the product. Or else the fear that the FDA may not approve pod-based Vuse alto or tank based Vibe products. Although they are more effective there were doubts about them getting  FDA approval.

The submission has raised some questions for the independent manufacturers who might be looking forward to applying for the same. Submission of flavored cartridges for approval by the tobacco company is very interesting but also suspicious.

  •     A weak cigarette-like product like Solo will be approved by the FDA? And if it does, then will they deny the same in a more powerful, high nicotine pod vape?
  •     Is it necessary to have a tamper-proof design like the Solo cartridges for approval of flavored products?
  •     Can small manufacturers afford to produce research sufficient to give the FDA cover for approving open-system products like bottled e-liquid?
  •     How will PMTA approval be affected by the Trump administration’s announced the flavor ban?

Although the questions might not be answered soon, hence it will not help the small vape companies. RJ Reynolds application too will take more than seven months to be accepted and evaluated by the FDA staff. Till then the PMTA deadline would pass, which means no small vape companies would get any information or help with this application.

A federal judge mandated the new deadline for PMTA submission, which is May 11, 2020. He also granted the vaping industry applicants the right to intervene, and they can also challenge the decision. To which the Vapor Technology Association (VTA) issuing, in order to prevent the FDA from imposing the new deadline.

RJ Reynolds suggested to the FDA to regulate the open system vapes and put a ban on them. Whereas the vape shops should be considered as tobacco manufacturers. It becomes very difficult to assess the open system for the FDA. Also, such products can be combined in multiple ways and used by consumers.    

Reynolds also said, “The open system cannot be evaluated just the closed-system products, the open system products are customizable, which results in multiple uses. Also, it becomes difficult to know whether the product is consistent and maintains a quality level.

It seems that the cigarette company’s suggestions were accepted by the FDA. The Deeming Rule made it clear that open system products would not find it easy to be approved, and hence the FDA would favor self-contained devices with no interchangeable parts.

Ever since the Deeming rule came into existence, there has been no instance where the manufacturer tried to get FDA approval for e-liquid based vaping products. Philip Morris International’s heat-not-burn tobacco products IQOS was the only product that was submitted. The product received approval after more than two years of struggle. Although it is said that PMI spent billions of dollars on research before submitting the application. Also, they sent only two of the flavors for approval, which were menthol and tobacco.

The new PMTA guidance released by the FDA has made things more difficult for small business owners, as the complexity of the procedure and the cost of research is beyond their capacity.  RJ Reynolds also claims it filed more than 150,000 pages for documents, just for the application of the Vuse Solo product.

An executive from Reynolds states how difficult and time-consuming it was to file an application to the FDA. He said, “it took a lot of hard work and included multiple teams which had more than 100 members. Many of them were Ph.D. team members, and on top of that, all the financial investment the company put in.”

Looking at the market, it is obvious that no small manufacturer could match the amount of money spent by RJ Reynolds. As  no company can match their level, the question is, even if the company spends so much money. Will the FDA approve the product and consider flavored vaping as appropriate?

What if the product is rejected by the FDA? Let us assume that companies do file an application and submit it to the FDA, but still, it would take a lot of time for them to conclude. Between that period of time, what are they supposed to do? They do not even have any backup options like cigarettes, which can run the business. And also what if, after all the struggle, the product is rejected?

The entire scenario has brought the vaping industry in a fix. There is no way out of it right now, the only thing that can help them is the removal of the PMTA guidance. The unnecessary pressure on the small business owner is not fair since they work hard to run their house. The authorities are trying to bring down their only source of income.