SILVER SPRING, Maryland – While the United States Food and Drug Administration (FDA) continues to adjudicate pre-market tobacco product applications (PMTAs), it has issued marketing orders on tobacco products submitted through other marketing channels. .
As of Sept. 8, the FDA has issued Substantial Equivalence (SE) Marketing Orders covering more than 120 products and Exemption Request Marketing Orders (EX REQs) covering more than 230 products, wrote the Center Director. for Tobacco Products (CTP) of the FDA, Mitch Zeller. in a note of September 9.
While PMTAs are submitted when a company applies for marketing authorization for a new tobacco product, SE and EX REQ applications are generally submitted for new tobacco products that resemble a main product or have been modified. However, most applications for reputable new tobacco products have gone through the PMTA route, with more than 6.5 million tobacco products submitted for review, the FDA said.
The FDA has said it needs more time to review the PMTAs it received by the September 9, 2020 deadline, but has acted on about 93% of them so far. No market orders have been issued for tobacco products submitted through the PMTA process since Philip Morris Product SA’s IQOS application in December 2020, according to the FDA website.
According to the court order, products for which claims were submitted before the deadline could generally remain on the market for up to a year from the date of the claim, which was Thursday at the latest, pending the FDA review. The FDA retains its enforcement discretion, however, and has said its highest enforcement priorities will be products for which no pending applications are pending.
The FDA intends to continue to devote significant resources to responding to the remaining pending applications and will release its decisions on an ongoing basis, Zeller said.
Zeller noted in the announcement that although different tobacco products pose different levels of risk, all tobacco products are “inherently dangerous.”
“Whether they receive marketing authorization or not, there are no safe tobacco products. People who are not currently using tobacco products, especially young people, should not start, ”Zeller said.
As tobacco suppliers wait for the FDA to complete the PMTA review process, many are convinced that their products are appropriate for the protection of public health. Here’s what three vendors said CSP following the FDA announcement that it needed more time to review PMTAs:
- E-Alternative Solutions, Jacksonville, Fla .: “At this time, the PMTAs filed by E-Alternative Solutions for its Leap and Leap Go ENDS products remain under scientific review,” Chris Howard, vice president, general counsel and lead of compliance. to EAS, said. “We are convinced that we have provided sufficient evidence to demonstrate that authorizing 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 any additional information it may need now and in the future. The FDA statement shows that the Center for Tobacco Products has made great strides in accomplishing the Herculean task of examining more than 6.5 million PMTAs. It appears that the FDA is going through 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 in-depth review of our applications based on science and evidence, which is essential to advance risk reduction and obtain a license to operate” , a spokesperson for the company Juul Labs. noted. “We remain committed to keeping adult smokers away from combustible cigarettes while tackling underage consumption. “
- RJ Reynolds Tobacco Co., Winston, Salem, NC: “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 public health,” said a spokesperson for the company. . “In addition, we believe that these important and innovative product categories may be potentially less harmful than traditional tobacco products. “
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