SILVER SPRING, Md. — While the U.S. Food and Drug Administration (FDA) continues to rule on premarket tobacco product applications (PMTAs), it has issued marketing orders on tobacco products submitted through other pathways to market.
As of Sept. 8, the FDA has issued substantial equivalence (SE) marketing orders covering more than 120 products and exemption request (EX REQ) marketing orders covering more than 230 products, the FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller wrote in a Sept. 9 note.
While PMTAs are submitted when a firm is seeking marketing authorization for any new tobacco product, SE and EX REQ applications are typically submitted for new tobacco products that are like a predicate product or that have been modified. Most applications for new deemed tobacco products, though, came through the PMTA pathway, with more than 6.5 million tobacco products submitted for review, the FDA has said.
The FDA said it needs more time to review the PMTAs it received by the Sept. 9, 2020, deadline, but it has acted on about 93% of them so far. No marketing orders have been issued for tobacco products submitted under the PMTA process since Philip Morris Product S.A.’s IQOS application in December 2020, according to the FDA’s website.
According to the court order, products for which applications were submitted by the deadline could generally remain on the market for up to a year from the date of the application, which was Thursday, at the latest, pending FDA review. The FDA retains enforcement discretion, though, and has stated its highest enforcement priorities will be products for which no application is pending.
The FDA intends to continue to devote significant resources to responding to the remaining pending applications and will issue its decisions on a rolling basis, Zeller said.
Zeller noted in the announcement that while different tobacco products have different levels of risk, all tobacco products are “inherently dangerous.”
“Whether they receive a marketing authorization or not—there are no safe tobacco products. People who do not currently use tobacco products, especially young people, should not start,” Zeller said.
As tobacco suppliers await the FDA’s completion of the PMTA review process, many are confident that their products are appropriate for the protection of public health. Here’s what three suppliers told CSP following the FDA’s announcement that it needed more time to review PMTAs:
- E-Alternative Solutions, Jacksonville, Fla.: “As of this moment, the PMTA’s filed by E-Alternative Solutions for its Leap and Leap Go ENDS products remain in scientific review,” Chris Howard, vice president, general counsel and chief compliance officer at EAS, said. “We are confident we provided sufficient evidence to demonstrate that permitting the marketing of our products is appropriate for the protection of public health. We look forward to continuing to work with the Agency to provide additional information it may require now and in the future. FDA’s statement shows that the Center for Tobacco Products has made great strides in completing the herculean task of reviewing more than 6.5 million PMTAs. It appears that FDA is committed to a rigorous scientific review process and is working to expedite the process and provide regulatory certainty.”
- Juul Labs, San Francisco: “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate,” a Juul Labs company spokesperson said. “We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”
- R.J. Reynolds Tobacco Co., Winston, Salem, N.C.: “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of the public health,” a company spokesperson said. “In addition, we believe that these categories of important, innovative products may be potentially less harmful than traditional tobacco products.”