CEO of FDA Testing Partner Says Products with New Technology Are More Likely to Pass PMTA Applicatio

Tom Beaudet, CEO of Accorto Regulatory Solutions, an FDA testing partner, believes that the FDA still hopes to approve flavored products, and devices with new technology are more likely to pass the PMTA application.

During an exclusive interview with Two Supremes on September 21 at the 2023 GTNF forum in Seoul, Tom Beaudet shared his views on compliance issues, particularly regarding PMTA. He finds it encouraging that the FDA still hopes to approve flavored products, and that products with new technology are more likely to pass the PMTA application. 

Tom Beaudet, CEO of the FDA testing agency, in an exclusive interview with Two Supremes (right) | Source: Two Supremes 

Tom Beaudet stated that his company helps small and medium-sized enterprises bring FDA-regulated products to market, a significant portion of which are tobacco nicotine products; the company also operates in the medical device and other pharmaceutical sectors.  

Accorto Regulatory Solutions has been involved in the PMTA process since 2018, preparing for the first round of PMTA applications in 2020. In 2020, the company submitted applications on behalf of 10 different companies, many of which were device manufacturers from Shenzhen, China, and all these applications are still under FDA review. Subsequently, applications for about 15 more companies were submitted, with over 1,000 product applications currently awaiting final review.

Regarding the main challenges faced by e-cigarette companies in the FDA's PMTA application process and how to address these challenges, Tom Beaudet provided answers. He stated that for companies producing flavored (e-cigarette) products, the biggest challenge is obtaining approval for these flavored products. Brian King, Director of the FDA's Center for Tobacco Products, spoke at the GTNF forum, clearly stating that the FDA has not banned flavors; they are waiting for companies to provide scientific data proving that flavored products are more effective for adult smokers looking to quit than using tobacco, and that this demand outweighs the risks to underage users.

Tom Beaudet said, "We have just completed the first round of cohort studies, and the scientific data clearly shows that adult smokers can effectively reduce or completely quit smoking through flavored e-cigarettes, while tobacco-flavored e-cigarettes do not have this effect. Additionally, we are closely collaborating with another company that has technology that makes it difficult for underage users to access disposable devices. We firmly believe that if we submit an application for a long-term collaborative study and implement these new technologies into the devices, there is a high likelihood of obtaining market approval."

Tom Beaudet cannot agree with applying for PMTA just to sell their products in the short term and evade FDA regulation. He believes that the ultimate goal of applying for PMTA is to obtain market approval for long-term development. He stated that the PMTA application process is divided into two phases: the first phase takes about three months and focuses on obtaining an approval letter for the company. Once the approval letter is obtained, the company will receive a PMTA number from the agency; the second phase involves returning to conduct all scientific research and provide data to supplement the initial application so that the FDA can ultimately review the product.

“Dr. King has recently emphasized multiple times that the FDA recognizes that using e-cigarette products is safer than smoking, and he reiterated this point today. The challenge lies with flavored products; they are waiting for companies to provide scientific data to prove that flavors are more important to adult smokers looking to quit than just tobacco,” Tom Beaudet said. 

Tom Beaudet finds it encouraging that the FDA still hopes to approve flavored products, but relevant scientific research must be conducted. He looks forward to providing scientific data to the FDA. 

Tom Beaudet 

CEO of Accorto Regulatory Solutions, a testing company collaborating with the FDA