29 Mar FDA Proposes New Rule to Clarify Tobacco Product Application Guidelines
Yesterday, the FDA made available a newly proposed rule intended to improve and clarify aspects of the tobacco product premarket application review process. (The FDA will formally publish the proposed rule in the April 2, 2019, edition of the Federal Register.) In general, introduction of a “new tobacco product” to the U.S. market requires a premarket authorization from FDA. The newly proposed rule relates to the type of application most commonly used by industry to date, the so-called Substantial Equivalence (SE) report. In an SE report, a manufacturer must prove the new tobacco product’s substantial equivalence to a predicate tobacco product.
To date, industry had to rely on published materials from prior SE report reviews and limited guidance from FDA in understanding the Agency’s expectations for the contents of SE reports and procedures for their review. Previously, FDA expectations for SE reports have not been clear, leading to confusion for manufacturers and uncertainty for retailers. Under the proposed rule, the FDA would establish in regulations the minimum requirements for manufacturers and key procedures related to SE report reviews. We are hopeful that this will lead to more-predictable outcomes, making it easier for manufacturers and retailers to plan for their businesses.
IPCPR applauds the FDA for taking this important step toward clarifying the Agency’s expectations for SE reports and separately publishing information on common ”deficiencies” in SE reports, specifically those for cigars and pipe tobacco. We look forward to engaging with the FDA on these issues, including by filing comments on the proposed rule during the comment period, which ends June 17, 2019. IPCPR will also continue to work with lawmakers to create a regulatory environment in which premium cigar businesses can thrive. To read the full FDA announcement CLICK HERE.