August 14, 2018

Media Inquiries

  Michael Felberbaum
  240-402-9548

“We’re taking additional steps to improve the efficiency and effectiveness of our review process for tobacco product applications, as part of the commitments we made when we unveiled our comprehensive framework last summer,” said FDA Commissioner Scott Gottlieb, M.D. “We’re committing to provide additional information about the FDA’s science-based review decisions to manufacturers who’ve received a decision from the FDA that their product has not met the standards for authorization under the agency’s pathway for demonstrating substantial equivalence to a predicate tobacco product. This information can help sponsors better understand the options for addressing the FDA’s concerns, and help make sure new tobacco products meet the FDA’s regulatory standards. By proactively sharing this information, rather than waiting for companies to submit requests for them through the FOIA process, sponsors will be able to more quickly consider the scientific concerns outlined during the FDA’s review. We also plan to announce additional improvements to the product application and review processes this fall that we expect will provide industry more predictability on timelines for the review of certain applications. We’re committed to the effective and appropriate regulatory oversight of tobacco products as part of our comprehensive efforts to protect kids and significantly reduce tobacco-related disease and death.”

The U.S. Food and Drug Administration announced today that the agency is improving transparency regarding applications for a subset of tobacco products – known as “provisional substantial equivalence (SE) tobacco products.” As part of this process improvement, starting this week, a copy of the summary review and the final cycle primary discipline reviews that serve as a basis for the agency’s not substantially equivalent (NSE) decision will be made available to companies receiving NSE orders for these provisional SE applications. Companies previously obtained such documents by filing a Freedom of Information Act (FOIA) request. Any review documents other than those issued with an NSE order may still be obtained by submitting a FOIA request.

The FDA also expects to announce additional process improvements ahead of a public meeting to be held Oct. 22-23, 2018. This public meeting is planned to discuss the policies and processes for tobacco product application review, including the general scientific principles relevant to SE Reports, exemption requests, premarket tobacco product applications (PMTA) and modified risk tobacco product (MRTP) applications. The meeting will seek suggestions for further process improvements. Presentations from FDA staff, expert panels and live question-and-answer sessions are expected to address other topics relevant to the submission of tobacco product marketing applications, including tobacco product master files, meeting requests, grandfathered review and environmental assessments.

In July 2017, the FDA announced a new comprehensive plan for tobacco and nicotine regulation that aims to ensure the agency has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. As part of that plan, the FDA, among other things, intends to issue regulations outlining what information the agency expects to be included in PMTAs, MRTP applications and SE Reports. The FDA also plans to finalize guidance on how it intends to review PMTAs for electronic nicotine delivery systems. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.