The Progressive Policy Institute (PPI) welcomes the opportunity to provide comments on the draft guidance for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk. We appreciate that the draft guidance clarifies FDA’s position on flavored ENDS, including what the agency describes as a “sliding scale” regarding the evidentiary burden for various ENDS flavorings. Importantly, the draft guidance makes it clear that the agency does not have a de facto flavor ban for e-cigarettes. Despite this appreciation, the draft guidance fails to account for critical real-world factors that should inform FDA’s perspectives on the potential risks and benefits associated with flavored ENDS.
The draft guidance suggests “FDA’s current approach to PMTA review for determining whether a flavored ENDS product is ‘appropriate for the protection of the public health’ (APPH) includes evaluating the risks and benefits, considering all relevant evidence and circumstances associated with the new product to the population as a whole.” However, the draft guidance does not sufficiently acknowledge the following “relevant evidence and circumstances” or describe how these factors were considered when FDA conceptualized the evidentiary burden necessary to authorize flavored ENDS:
By not adequately accounting for these factors, the proposed framework is likely to overestimate the risks flavored ENDS pose to youth, undervalue their potential benefits to adults who smoke cigarettes, and fall short in helping address the illicit ENDS marketplace. In the context of declining rates of youth use and growing public safety concerns with illicit tobacco products, FDA guidance should provide clear pathways that are likely to accelerate the authorization of flavored ENDS products that benefit adult smokers, better meet adult consumer demand, and begin to draw consumers away from unregulated products and the illicit market.
