SBA Urges Another Year of Sales for PMTA-Submitted Products

A federal agency dedicated to advocating for small business has urged the FDA to pursue permission to allow vaping manufacturers to keep products on the market for another year while their premarket reviews are in progress.

In a letter sent to the FDA on June 7, the Small Business Administration (SBA) Office of Advocacy asked the regulators to seek a court order extending for an additional year the current moratorium on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.

The letter was sent to FDA Acting Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller, and copied to the White House. It was signed by SBA Office of Advocacy Acting Chief Counsel Major L. Clark III. The Office of Advocacy’s mission is to represent the views of small business to Congress, the White House, federal agencies, federal courts, and state policymakers.

The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the length of time that products may remain on the market without PMTA approval or FDA enforcement for an additional year, until September 2022. Grimm set the PMTA deadline as part of his 2019 judgement against the FDA in a lawsuit brought by several tobacco control groups, led by the American Academy of Pediatrics (AAP).

In his ruling, Grimm allowed all manufacturers who submitted applications on time to have a one-year extension (until Sept. 9, 2021) to continue selling without FDA enforcement, and said the FDA could grant further extensions to the one-year grace period on a “case-by-case basis” for “good cause.” But he did not give the FDA leeway to grant an exemption covering all submitted products. That would require a new order from Judge Grimm, and would likely be opposed by the groups that sued the FDA to move up the PMTA deadline.

As things stand now, manufacturers who submitted PMTAs on time last year may leave those products on the market until Sept. 9, 2021. After that date, according to regulatory attorney Azim Chowdhury, only products deep into the PMTA process are likely to receive “case-by-case” extensions of enforcement discretion.

“For companies who are in scientific review, have responded to deficiency letters, and have studies or testing ongoing—that’s within the discretion of the FDA to grant extensions without going to Judge Grimm,” Chowdhury told Vaping360. “But any blanket extension would be immediately challenged [by the plaintiffs in the AAP lawsuit].”

Because hundreds of vaping manufacturers submitted PMTAs last year for more than six million products, there is no chance the FDA will be able to process the applications before manufacturers are required to pull their products off the market. The SBA authors recognize that in their letter to the FDA.

“Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”

The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market.

The SBA letter doesn’t mean the FDA will ask Judge Grimm to extend the enforcement grace period, but it is an encouraging development. There has been discussion among vaping businesses and advocates about formally petitioning the FDA for a blanket extension of the enforcement discretion period. The SBA request could add weight to such a request, and might offset the pressure anti-vaping groups will bring to bear on the FDA.