BY ERIK J. MACLAREN, PHD
In May 2016, the U.S. Food and Drug Administration (FDA) finalized the deeming rule that extended the agency’s regulatory authority to include all tobacco products, including e-cigarettes, cigars, and hookah, and pipe tobacco. IASLC Drug Cancer News spoke with Mitch Zeller, JD, Director of the FDA Center for Tobacco Products to learn more about the impact of this new rule on tobacco product regulation.
Q: What is the future of tobacco product regulation in the United States?
A: The deeming rule marked a new chapter in the agency’s efforts to end preventable tobacco-related disease and death. Provisions aimed at restricting youth access took effect immediately upon the rule’s effective date of August 8, 2016, effective date, and on September 15, the FDA took action against 55 tobacco retailers by issuing the first warning letters regarding selling newly regulated tobacco products to minors.
The rule provided the foundation for the FDA to regulate tobacco products that young people were using at an alarming rate, and that had previously gone largely unregulated. Among other requirements, the rule requires manufacturers of newly regulated products to meet the applicable public health standard set forth in the Family Smoking Prevention and Tobacco Control Act (TCA) and in the deeming rule, and to receive the FDA’s marketing authorization, unless the product was on the market as of February 15, 2007. The FDA has provided a staggered compliance time frame for industry to submit applications for this type of authorization.
The FDA plans additional steps to protect youth, including issuing a separate proposed rule to extend the existing flavor ban on cigarettes to cover cigars with characterizing flavors, including premium cigars, little cigars, and cigarillos. The agency also intends to issue rules to require nicotine exposure warnings and childresistant packaging for products with e-liquids.
Q: How have tobacco companies responded to the expansion of the FDA’s regulatory authority under the deeming rule?
A: Since the deeming rule’s May 2016 finalization, the FDA has received about 6,000 inquiries by phone or email from manufacturers and retailers about the deeming rule and about the requirements to comply. Steps the FDA has taken to proactively support regulated industry have included:
• Redesigning the Center for Tobacco Products’ online information about deeming to clearly set forth the rule’s provisions and delineate compliance requirements;
• Hosting webinars on various deeming-related topics;
• Preparing guidances to discuss the agency’s current thinking on regulatory topics related to deeming; and
• Assisting small businesses through the Center for Tobacco Products’ Office of Small Business Assistance.
Q: What is the FDA’s perspective on Electronic Nicotine Delivery Systems (ENDS) products as potential smoking cessation devices?
A: The FDA recognizes some tobacco products have the potential to be less harmful than others. The agency believes ENDS products have potential benefits and risks, and that more scientific evidence is needed about these. By reviewing individual applications, the FDA will be able to answer important questions about what ingredients are in ENDS products, to help establish whether they are beneficial or harmful and to whom.
Certain ENDS may have reduced toxicity compared to conventional cigarettes, they may encourage current smokers to switch completely, and/or they may have the potential to reduce disease and death if not widely used by youth. However, if any of these products prompt young people to become addicted to nicotine, diminish their interest in quitting cigarettes, and/or lead to long-term dual usage with other tobacco products, the public health impact could be negative.
If an ENDS product is marketed for tobacco cessation or any other therapeutic purpose, the product will be regulated as a drug or device, rather than as a tobacco product.
Q: What types of research are useful in supporting the FDA’s regulatory decision-making relating to tobacco products and especially ENDS?
A: In support of its mission to protect the public health, the FDA is committed to continually learning more about the potential health impacts—whether beneficial or harmful—of ENDS and other products in the evolving tobacco marketplace. The science base is developed through extensive research on important factors such as product toxicity, appeal, and initiation, including studies the agency itself conducts and supports, and through the information that companies submit to comply with the TCA and deeming rule requirements.
For those companies submitting a premarket tobacco product application (PMTA) for e-cigarettes—the pathway that the FDA expects to be the most common for these products—the agency has developed a draft industry guidance that is available for public comment. The “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” draft guidance includes information the agency recommends be submitted in a PMTA for an ENDS product, to show whether permitting the new tobacco product to be marketed is appropriate for the protection of the public health. For example, the PMTA ENDS draft guidance discusses circumstances when a new clinical trial might be helpful and when it might be less necessary; the FDA looks forward to comments in this area.
Another, more general draft guidance titled “Applications for Premarket Review of New Tobacco Products” is also available; this covers the types of information that the FDA proposed be included in a new tobacco product application. The agency is currently reviewing comments received on this draft guidance. ✦