FDA Issues Proposed Rule for Premarket Tobacco Product Applications

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FDA Issues Proposed Rule for Premarket Tobacco Product Applications

The U.S. Food and Drug Administration (FDA) has issued a proposed rule addressing the requirements for the content, format and FDA’s review of and communications procedures for premarket tobacco products applications (PMTAs). PMTAs are part of the process which manufactures of deemed tobacco products–including cigars, pipe tobacco, e-cigarettes and vaping products–can take to get authorization from the FDA to sell, distribute and market tobacco products in the U.S.

Through the PMTA process, manufacturers are responsible for demonstrating to the FDA that the marketing of the new tobacco products would be “appropriate for the protection of the public health.” The FDA takes into consideration the risks and benefits to the population as a whole, including users of these products and non-users. The FDA will look at each tobacco products’ ingredients, additives, constituents, toxicological profile and components and how they will impact the public health. The evaluation process also includes examining how the products are manufactured, packaged and labeled.

“Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health. This will include understanding the likelihood that those who do not use tobacco products – such as kids – will start using them, as well as the likelihood that tobacco users will stop. And as I’ve said before, responsible manufacturers certainly don’t need to wait to act. We encourage industry to use available FDA resources as a guide for their submissions to the agency,” commented Acting FDA Commissioner Ned Sharpless, M.D. in a press release. “This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products. These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.”

Due to a court order that was issued by a U.S. District Court judge in Maryland months ago [read more here], manufacturers are required to submit premarket applications to the FDA by May 12, 2020 for any deemed tobacco products–including cigars and e-cigarettes–that were on the market as of Aug. 8, 2016.

For e-cigarette and ENDS manufacturers in particular, the FDA issued final guidance this past June to help navigate the PMTA application process but a final rule has yet to be published. The FDA says a final rule, however, isn’t needed for manufacturers to continue submitting PMTAs to the agency. The proposed rule outlines the general process the FDA will take when evaluating PMTAs, including application acceptance, application filing and inspections. It also outlines how amendments to an application can be filed, how an application can be withdrawn, how to address changes in ownership, post-market reporting and maintenance of records, FDA communications with an applicant, FDA’s disclosure procedures and electronic submission requirements. The proposed rule also explains how applicants can submit supplemental PMTA or a resubmission and how to respond and address receiving a “No Marketing Order” from a deficient application.

The proposed rule will open for public comments for 60 days through Nov. 25, 2019.

You can read the proposed rule for premarket tobacco product application and record keeping requirements by clicking here.