In a Vapor Voice article entitled “All Hands On Deck”, Timothy Donahue sifts through the information regarding the premarket tobacco review process as it pertains to the vapor industry. Donahue’s article condenses the key factors of what could be an overwhelming process for many vapor companies. As Donahue notes, “the clock just started ticking a lot faster” for vapor companies who plan to submit PMTAs, due to a court-ruling by a U.S. District Court in Maryland that bumped the original PMTA deadline from August 2022 to May 2020.

Throughout the article, Donahue unpacks the unique challenges facing vapor companies in the wake of this new deadline, and the ways in which this amplified time constraint is making an already cumbersome process particularly difficult. Donahue enlists the expertise of Troutman Sanders attorneys Bryan Haynes, Agustin Rodriguez and Neelam Gill throughout the article—noting their views regarding the PMTA process. Regarding the changes from the original draft guidance, released in 2016, to the final guidance in June 2019, Donahue quotes Agustin Rodriquez, who says that “the final guidance provides additional recommendations regarding battery safety, including testing certificates for any voluntary electrical standards” as well as “new recommendations for [the] testing of harmful and potentially harmful constituents.”

Donahue also discusses the potential money and time saving options for companies undergoing the testing process for PMTAs, particularly bridging and tobacco product master files (TPMFs). Donahue quotes Troutman Sanders attorney Neelam Gill, who states that bridging “allows applicants to reference information that is already known for a particular product with appropriate justification…when justified, the bridging approach uses a body of information to extrapolate safety and health data in cases where these specific data do not exist.”

The possibility of TPMFs is an appealing one for companies submitting PMTAs for ENDS products, according to Donahue. However, due to the “trailblazing” nature of the PMTA process for ENDS, TPMFs “won’t be available to reference until at least some products survive the PMTA process and receive approval.” The article quotes Bryan Haynes, who explains that the TPMF “approach simplifies the premarket process by helping applicants benefit from increased efficiencies and reduced costs because applicants can simply use the reference information in TPMFs rather than developing the information on their own.” While Donahue’s article speaks largely to the uncertainty of the PMTA process for ENDS manufacturers, it includes information such as the potential of TPMFs to help companies consider the long-term opportunities of their investments during the PMTA process.

Donahue notes that the “PMTA process is going to consume much of the vapor industry’s energies” approaching the May 2020 deadline. Part of the challenge, according to the article, is the amount of uncertainty surrounding the submission process and, in turn, the outcome. In the closing paragraphs of the article, Donahue emphasizes that companies should recruit professionals who are experts in FDA regulation of tobacco products and PMTA submission requirements. Donahue explains that “if a company is just now getting started in this process and is looking for help in submitting its PMTA application, that company should ‘go with somebody that has experience with the FDA.’”
article, Donahue unpacks the unique challenges facing vapor companies in the wake of this new deadline, and the ways in which this amplified time constraint is making an already cumbersome process particularly difficult. Donahue enlists the expertise of Troutman Sanders attorneys Bryan Haynes, Agustin Rodriguez and Neelam Gill throughout the article—noting their views regarding the PMTA process. Regarding the changes from the original draft guidance, released in 2016, to the final guidance in June 2019, Donahue quotes Agustin Rodriquez, who says that “the final guidance provides additional recommendations regarding battery safety, including testing certificates for any voluntary electrical standards” as well as “new recommendations for [the] testing of harmful and potentially harmful constituents.”

Donahue also discusses the potential money and time saving options for companies undergoing the testing process for PMTAs, particularly bridging and tobacco product master files (TPMFs). Donahue quotes Troutman Sanders attorney Neelam Gill, who states that bridging “allows applicants to reference information that is already known for a particular product with appropriate justification…when justified, the bridging approach uses a body of information to extrapolate safety and health data in cases where these specific data do not exist.”

The possibility of TPMFs is an appealing one for companies submitting PMTAs for ENDS products, according to Donahue. However, due to the “trailblazing” nature of the PMTA process for ENDS, TPMFs “won’t be available to reference until at least some products survive the PMTA process and receive approval.” The article quotes Bryan Haynes, who explains that the TPMF “approach simplifies the premarket process by helping applicants benefit from increased efficiencies and reduced costs because applicants can simply use the reference information in TPMFs rather than developing the information on their own.” While Donahue’s article speaks largely to the uncertainty of the PMTA process for ENDS manufacturers, it includes information such as the potential of TPMFs to help companies consider the long-term opportunities of their investments during the PMTA process.

Donahue notes that the “PMTA process is going to consume much of the vapor industry’s energies” approaching the May 2020 deadline. Part of the challenge, according to the article, is the amount of uncertainty surrounding the submission process and, in turn, the outcome. In the closing paragraphs of the article, Donahue emphasizes that companies should recruit professionals who are experts in FDA regulation of tobacco products and PMTA submission requirements. Donahue explains that “if a company is just now getting started in this process and is looking for help in submitting its PMTA application, that company should ‘go with somebody that has experience with the FDA.’”