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Tobacco

FDA to Revisit New Product Application Process

Agency sets public meeting on premarket review for October

SILVER SPRING, Md. – About a year after announcing a tobacco strategy involving nicotine levels in cigarettes and other related measures to reduce tobacco use among Americans, the U.S. Food and Drug Administration (FDA) said it will take another look at the process by which it evaluates new tobacco products and how it approves them for marketing and sale in the United States.

The current process, involving what many in the industry describe as an onerous and expensive premarket tobacco application (PMTA) and a modified-risk tobacco product application (MRTPA), will undergo an agency review that will include a public comment period and a two-day public meeting Oct. 22-23 at FDA headquarters in Silver Spring, Md.

Here’s what the agency announced in a blog post as its next steps:

  • Proposing foundational rules: We all need to be on the same page regarding the basic “rules of the road,” especially when it comes to what’s expected in premarket applications. We’re working to propose new rules to help industry on topics including substantial equivalence, premarket tobacco applications, modified risk tobacco product applications and tobacco product manufacturing practices. We will begin publishing these foundational proposed rules in the coming months. They will lay out a transparent, modern and science-based framework for manufacturing practices and the development of tobacco product applications that meet the legal requirements.
  • Holding a public meeting on premarket review: Within the next few months, the FDA will hold a public meeting on the premarket application and review process. The goal of the meeting is to solicit comments on our processes and provide a dedicated venue for specific suggestions on how to further improve them. Potential topics for discussion include how to achieve greater efficiencies in review, while continuing to protect public health; how to review products that are rendered “new” due to changes made to comply with a product standard; and how to facilitate greater company consultation with the FDA prior to submitting applications.
  • Exploring opportunities for premarket review efficiencies through rulemaking and guidance and new administrative steps to modernize and improve the review process: The FDA is taking additional steps to pursue ... increased flexibility and efficiencies within the application review process. If carefully developed, rulemaking and guidance efforts in this area could help ensure that our public health standards for premarket review are met while mutually benefiting both the industry and the FDA. For example, an opportunity may exist to allow for faster and cheaper development of products that will benefit public health. In the months ahead, the FDA intends to explore what improvements can be made along these lines within our existing legal authorities. We also plan to advance a comprehensive suite of improvements to the review process, as part of a regulatory modernization, to make our program more efficient, transparent, predictable and efficient.
  • Expediting action on flavors: The issue of flavors, including flavored e-cigarettes and e-liquids, is at the forefront of any discussion of youth use; however, some flavored tobacco products may also play a role in helping some adults quit smoking cigarettes. Now that the comment period has closed, we intend to expedite the review and analysis of the comments so that we can leverage the information into policy as quickly as possible, should the science support further action.
  • Developing an e-cigarette product standard: The FDA has also begun exploring a product standard for e-cigarettes to help address existing concerns. As part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin and nicotine in e-liquids. While the process for establishing a product standard takes time, we recognize the urgency in setting some minimum common-sense standards and will work to address this on an accelerated timeline.
  • Exploring ways to accelerate enforcement: We’re also looking at ways that the FDA can act even more efficiently when we become aware of violations affecting youth use of e-cigarettes, such as illegal product marketing to youth. We need to be faster and more agile when we identify new risks. We’ve also become aware of reports that some companies may be marketing new products that were introduced after the FDA’s compliance period and have not gone through premarket review. These products are being marketed both in violation of the law and outside of the FDA’s announced compliance policies. We take these reports very seriously. Companies should know that the FDA is watching, and we will take swift action wherever appropriate. We are evaluating new ways to strengthen our partnership with sister agencies, including the Federal Trade Commission (FTC). We will also announce a robust series of additional enforcement actions in the coming months.

The agency said it will unveil these program reforms in advance of its upcoming public meeting. “These programmatic and process improvements are aimed at solidifying the FDA’s regulatory pathways and improving its predictability and transparency,” agency officials said in the blog post.
 

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