To mark the nine-year anniversary of the Family Smoking Prevention and Tobacco Control Act and the one-year anniversary of FDA’s Comprehensive Plan for Nicotine, FDA recently provided updates on efforts to improve its tobacco regulatory programs. In addition, FDA announced new initiatives that are designed to help industry have a better understanding of what is needed to submit complete and robust tobacco product applications. The stated objective of these efforts is to improve the transparency and efficiency of the premarket review process.

Specifically, FDA is working on foundational rules – which it refers to as “the basic rules of the road” — to guide industry on the following topics:

  • Substantial Equivalence
  • Premarket Tobacco Applications
  • Modified Risk Tobacco Product Applications
  • Tobacco Product Manufacturing Practices

FDA states that it currently plans to publish these foundational, proposed rules in the coming months. In addition to laying out the Agency’s expectations for tobacco product applications, these foundational rules are intended to provide a transparent and science-based framework for tobacco product manufacturing practices. This is welcome guidance, as many of our questions from industry come related to this topic and seek to understand the level of manufacturing control that would sufficiently support tobacco product applications. It will be interesting to see what FDA comes up with as far as the quality control requirements and considerations for tobacco-related GMPs, or tobacco product manufacturing practices (TPMPs).

From a prioritization and timing standpoint, we hope that FDA plans to issue its tobacco product manufacturing rules sooner rather than later, given that TPMPs are indeed “foundational” in the sense that they form the basis of the validity of the data that goes into tobacco product applications and have the potential to impact virtually every aspect of the premarket review process. In addition, some quality requirements such as stability testing are, by their very nature, time-consuming and resource-intensive and must be planned well ahead of the marketing application submission date. We applaud the Agency’s efforts to clarify this important part of the application process for the industry.

For industry and stakeholders, we encourage taking advantage of any available opportunities to weigh in and provide input on FDA’s regulatory efforts while these topics are under ready consideration. For instance, within the next few months, FDA plans to hold a public meeting on the premarket application and review process. The Agency’s stated goal of this meeting is to obtain stakeholder feedback on its processes and provide a dedicated venue for detailed suggestions on improvements. As of now, the potential topics for discussion include:

  • improving efficiencies in review
  • how to review products that are rendered “new” due to changes made to comply with a product standard
  • how to facilitate greater company consultation with the FDA prior to submitting applications

Given the importance of these topics, we encourage industry participants to provide any ideas based on its experience thus far in the premarket review process. As always, we stand ready to help industry develop these comments so that they are communicated in a data-driven, logical, and legally supported manner to the Agency.