August 11, 2020

Volume X, Number 224

August 11, 2020

Subscribe to Latest Legal News and Analysis

August 10, 2020

Subscribe to Latest Legal News and Analysis

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, such as e-cigarettes, through an appropriate series of regulatory measures in order to fully evaluate their risks and possible benefits. FDA acknowledged that such a review process is important because it gives them the ability to evaluate important factors, like ingredients, product design, and health risks.

As part of this ongoing work, FDA held a two-day public meeting from October 22-23 to discuss the policies and processes for tobacco product application review. The meeting was held with the intention to improve public understanding and to seek feedback on FDA’s policies and processes for the submission and review of tobacco product marketing applications. In sum, the meeting addressed the following topics:

  • Overview of the tobacco product marketing applications types
  • Information that should be included in a tobacco product marketing application
  • Administrative processes involved in the submission and review of a tobacco product marketing application
  • Other relevant topics, including Grandfathered Review, Environmental Assessments, and Tobacco Product Master Files

The meeting builds on commitments FDA made in July 2017 when they announced their comprehensive regulatory plan for tobacco and nicotine products. For example, FDA continues to explore the development of product standards to protect the public health and make the review process more effective. FDA confirmed their intention to issue regulations and guidance outlining what information must be included in premarket tobacco product applications (PMTA), modified risk tobacco product (MRTP) applications, and substantial equivalence (SE) reports. FDA is hopeful that the information shared during the meeting can be used to ensure a clear and viable pathway for FDA tobacco product authorization, which could result in the marketing of potentially less harmful products for adult smokers. They also emphasized the importance of a strong application review process to ensure new tobacco products meet FDA’s standards and to reduce tobacco-related disease and death.

© 2020 Keller and Heckman LLPNational Law Review, Volume VIII, Number 297


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...