Staff Report
On September 9, 2020, the deadline for premarket tobacco applications (PMTAs) for new tobacco products, including e-cigarettes, came to pass, starting a one-year grace period that allows said products that were on the market before November 8, 2016 to remain in the market while the US Food and Drug Administration reviews their submissions.
Submitting a PMTA is a pathway to market new tobacco products defined in the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which grandfathered all tobacco products on the market before February 15, 2007.
The Center for Tobacco Products (CTP), created by the TCA, was initially responsible for regulating cigarettes, RYO, and smokeless tobacco. However, the CTP also had the power to deem additional products that contained nicotine made or derived from tobacco to be tobacco products, bringing them under the CTP’s authority. On May 5, 2016 the CTP issued a deeming rule that gave it regulatory authority over e-cigarettes, cigars, pipes and pipe tobacco, and hookah products.
Following the deeming rule, a number of cigars, pipes and pipe tobacco, and hookah products that had already been on the market before the 2007 grandfather date were able to continue to be sold without retroactive FDA approval. Unfortunately, the same could not be said for e-cigarettes or vaping products , as they had not been widely available on the market before the 2007 grandfather date and as such would have to go through the arduous, and expensive, PMTA process. A deadline of August 8, 2018 for submitting PMTAs was set. Manufacturers whose products were already being sold before the August 8, 2016 cut-off date could continue to keep their products on the market while their PMTAs were being reviewed. Any new products to come on the market after the cut-off date would need to submit a PMTA and get approval before even selling them.
The PMTA submission deadline had been delayed many times before it reached the final September 9, 2020 one. First it was set on August 8, 2018, then changed to November 8, 2018. In July 2017, then-FDA commissioner Scott Gottlieb pushed back the deadline to a more realistic one on August 8, 2022. However, after a group of tobacco control organizations sued the FDA in 2018, in 2019 a federal judge set the new deadline to May 12, 2020 and shortened the period a product under FDA review could stay on the market to one year. Notably, though, the judge also gave the FDA the ability to make exceptions to PMTA requirements on a case-by-case basis. Then, in 2020, the FDA appealed for a 120-day delay to the deadline due to the Covid-19 pandemic and challenges posed to applicants, and the deadline date changed to September 9.
Less than a month before the deadline, the US District Court for the District of Columbia ruled that the FDA could not move forward with the enforcement of PMTA requirements until it comes up with a streamlined process for premium cigars, effectively throwing out the September 9 deadline for this product category. At the time this article was being written, a new deadline has not yet been determined.
What about the smaller manufacturers?
One of the main concerns about the PMTA process was that it would effectively wipe out smaller manufacturers as each PMTA would require research and analysis that would cost millions of dollars, preventing smaller manufacturers from even trying to comply with the process and eventually having to go out of business. The FDA itself had previously estimated that the PMTA process would eliminate 99% of the e-cigarette market. Despite health and human services (HHS) secretary, Alex Azar, announcing plans back in January this year to create a “streamlined” PMTA process for smaller manufacturers, no changes have been made. The HHS is the parent agency of the FDA.
What may be a lifeline for smaller manufacturers is the possibility of them submitting PMTAs that are not necessarily as extensive as what the larger multinationals, with their resources, be able to provide. While there are definitely some PMTA components that are statutory requirements as specified in the TCA, much of the FDA’s industry guidance is not actually required by the TCA, simply just recommendations.
In the FDA’s industry guidance, the agency said, “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
One example is instead of having to go through conducting studies that prove their products, when used by adult smokers, are less harmful than smoking, smaller manufacturers could possibly submit an extensive literature review of peer-reviewed research on this subject, and reducing a significant portion of the cost of going through the PMTA process.
Another factor that may help smaller manufacturers is the fact that the FDA has been given the ability to make exceptions to PMTA requirements on a case-by-case basis.
Some smaller manufacturers have had their PMTAs accepted by the FDA. While no guarantee that they will be given final approval, at the very least it is a positive step and allows their product to remain on the market for another year.
The agency has shown signs of willing to work with applicants. On August 31, 2020, CTP director, Mitch Zeller, said in a statement that an August 31, 2020 statement from CTP director, Mitch Zeller, said, “Even if applications are submitted for only a portion of those products [more than 400 million products were registered in the FDA system], the likelihood of FDA reviewing all of these applications during the one-year review period is low.”
According to Zeller, the agency may not immediately reject applications that are immediately flagged for not containing the basic requirements to move to substantive review, but offer an opportunity to fix problems, saying that “although we expect high quality and complete applications to come in by September 9, if we do find deficiencies, it is likely FDA will issue a deficiency letter with a 90-day deadline for companies to respond.”
For the time being, at least for a year, it seems that we’ll have to wait with baited breath to see what comes out of these PMTA applications and what the consequences will be for consumers, the market, and industry.