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10/12/2021

FDA Finalizes Foundational Rules for Premarket Review of New Tobacco Products

New rules for Premarket Tobacco Product Applications and Substantial Equivalence Reports will be effective Nov. 4.
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SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued two final rules for the premarket review of new tobacco products.

These foundational rules provide additional information on the requirements for the content, format and review of two of the most commonly used pathways to bring a tobacco product to market: Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports 

"These final rules are important components of the FDA's comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions," said Acting FDA Commissioner Janet Woodcock, adding if new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.

The FDA gained regulatory control over tobacco under the 2009 Family Smoking Prevention and Tobacco Control Act.

"Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country."

According to the agency, the PMTA and SE final rules were displayed in the Federal Register but did not publish and were subsequently withdrawn.

The rules displayed last week reflect clarifying changes made from the previous versions, but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4.

Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.

PMTA Final Rule

Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that permitting the marketing of the new tobacco product(s) would be "appropriate for the protection of the public health."

The agency's evaluation includes such things as reviewing a tobacco product's components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled, findings from consumer perception research (if conducted), and the applicant's description of marketing plans for the product.

In addition to describing content and format requirements, the final rule formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, and application filing and inspections.

It also outlines, among other things:

  • Requirements for submitting application amendments;
  • The time for review;
  • Withdrawal of applications;
  •  Post-market reporting requirements for applicants that receive marketing granted orders;
  • The FDA's communications with an applicant;
  • The agency's disclosure procedures and electronic submission requirements; and
  • The final rule also explains how applicants may submit a supplemental PMTA or a resubmission.

SE Final Rule

In order for a new tobacco product to be found substantially equivalent, the FDA must determine either that it has the same characteristics as a predicate tobacco product, or that it has different characteristics than the predicate tobacco product but any differences in characteristics do not cause the new tobacco product to raise different questions of public health. 

The SE final rule provides additional information on the requirements for the content and format of SE reports, allowing for greater predictability and efficiency for all stakeholders by providing applicants with a better understanding of the level of detail that an SE report must contain for the FDA to evaluate the comparison of the new tobacco product to a predicate tobacco product, according to the agency. 

It also addresses:

  • The FDA's communications with the applicant;
  • The retention of records that support the SE report;
  • Confidentiality of an SE report;
  • How an applicant can amend or withdraw an SE report;
  • How an applicant may transfer ownership of an SE report to a new applicant; and
  • Electronic submission of the SE report and amendments.