In the last few days, news reports reveal that the FDA has accepted several premarket tobacco product applications (PMTAs) for review, including for Juul and for one or more unspecified Vaporesso products, and others have been submitted, including for Reynolds’ Velo Dissolvable Nicotine Lozenges.
The Juul news report says that FDA accepted Juul’s application less than three weeks after it was submitted on July 30, and the Vaporesso’s website crows that its PMTA was accepted “only three days after submission.”
FDA’s “acceptance” of a PMTA is not an authorization to sell the product. Rather, it means that the applications were sufficient to advance to FDA’s more substantive review process.
Here’s the process:
Before undertaking substantive review, FDA first determines whether the applications are complete. It the application is not complete, FDA may discuss with the applicant what is needed and give the applicant a chance to adjust their application.
If the application is still deficient, FDA may issue a "Refuse-to-Accept" or a "Refuse-to-File" order and the application will not receive substantive review. FDA issues "Refuse-to-Accept" determinations for very basic insufficiencies, such as if the submission is not in English, is in a format FDA can't read, or the necessary contact information was not provided. FDA may issue a "Refuse to File" determination if the application has more serious deficiencies such as an insufficient listing of ingredients and additives, lacks a full description of manufacturing methods, "lack of a reference to the artificial or natural characterizing flavor ban," or a specimen of the proposed product labeling was not provided.
With the September 9 deadline for submission of PMTAs rapidly approaching, as of July 21, FDA had already received 233 PMTAs in FY 2020. Of these, FDA “Refused to Accept” only three PMTAs (for deficiencies in the applications), issued “No Marketing Orders” for six products, and issued permissive Marketing Orders for two products (22nd Century’s Moonlight and Moonlight Menthol “very low nicotine” cigarettes).
Since FDA started regulating tobacco products, it has received 650 PMTA applications. Of those, FDA issued 371 Refuse-to-Accepts, 7 Refuse-to-files, 14 marketing orders (allowing the product to be sold in the US), 6 no-marketing orders, and 3 applications were withdrawn.
The law allows, but does not require, FDA to make PMTAs public and available for public comment and submit them to its Tobacco Products Scientific Advisory Committee (TPSAC) for public scrutiny. Because, to date, FDA has not exercised its authority to do this, we are forced to rely on news reports and company disclosures to learn anything about products that are seeking FDA’s marketing authorization.
This situation differs from applications companies submit to make reduced exposure or reduced harm claims about their products, which are known as Modified Risk Tobacco Product (MRTP) applications. The law requires FDA to announce receipt of MRTP applications and make them available for public comment by posting the contents of the MRTPs online, and requires FDA to submit the MRTPs to TPSAC for assessment in a public meeting.
FDA’s lack of transparency for PMTAs is a significant problem for public health. A statement by six health groups (American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative) issued on August 10, 2020 urged FDA to promptly make public sufficient information about the premarket review process to allow the public to assess industry compliance with, and FDA enforcement of, court-ordered deadlines, to enable the public to assess the sufficiency of the evidence presented in the PMTAs and provide input to FDA, and to allow the public to fully understand the basis for FDA’s finding that the product meets the required standard of being “appropriate for the protection of the public health.”
Making this information public and engaging the larger scientific community is particularly important because there is a broad consensus that the way FDA has handled the IQOS PMTA did not comply with the standard laid out in the 2009 Family Smoking Prevention and Tobacco Control Act to protect public health (Lempert and Glantz, Berman and Glaser, Lindblom).
Indeed, the six health groups made this point strongly in their letter: “The result [of the PMTA process to date] has been to authorize the marketing of new tobacco products without first requiring the manufacturer to meet its burden of demonstrating that the marketing of the product is “appropriate for the protection of the public health” taking into account the criteria set forth in the statute.”
With perhaps thousands of PMTAs expected to be filed by September 9 for e-cigarettes, dissolvables, and other new products, the stakes could not be higher.