LAKEVILLE, Minn. — Last month, after significantly highlighting its concerns related to underage use of flavored tobacco products, the U.S. Food and Drug Administration (FDA) announced and published a significant document outlining proposed changes to its compliance policy it is considering related to flavored e-cigarettes and vapor products and flavored cigars. The effect on the retail segment of the tobacco industry is likely to be significant. And just last week, following a request from NATO and other industry members to extend the comment period, the FDA announced it would extend the deadline by 15 days to April 30, 2019.
Upon the FDA publication of its document titled “Modifications to Compliance Policy for Certain Deemed Tobacco Products,” NATO began to thoroughly review and analyze the proposed changes. NATO’s analysis revealed a series of questions related to some ambiguities in the document, and the association promptly organized its questions and raised them with FDA. While the FDA was unable to provide the answers NATO sought, FDA officials encouraged us to raise the questions in our comment on the proposed guidance.
Shortly thereafter, NATO formally requested that the FDA extend the comment period on the docket by 60 days so that affected businesses—retailers and manufacturers—could properly review the potential impacts of the proposed changes and constructively engage in the comment process to affect the final outcome. While the FDA did not grant the request for a 60-day extension, NATO was pleased that the agency did choose to extend the process by 15 days.
During the Tobacco Merchants Association’s (TMA's) annual conference last week, NATO raised a question with Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), about whether current non-self-service tobacco layouts used in convenience stores and retail locations would meet the requirements of a heightened age-restriction policy as outlined in the proposed guidance. In response, Zeller said retailers should include in their comments on the proposed guidance all of the measures that convenience stores, gas stations, drugstores and grocery stores can and do take to restrict access to flavored e-cigarettes and vapor products by underage persons.
It is of critical importance that all affected retailers submit comments to the FDA on its proposed guidance. If you, as a retailer, have already submitted a comment, we strongly recommend that you submit additional comments as a supplement that include a list of measures your store or stores take to restrict access by underage persons to e-cigarette and vapor products. At NATO, we are working to both educate and engage our members (who represent more than 60,000 retail location across the country) to constructively comment on the proposed guidance so that regulators can appreciate the significant impact—even shuttered businesses—that the new compliance policy could have on thousands of retailers (many of whom have never been cited for any compliance issues).
Among other things, the proposed changes, once finalized, could remove hundreds of flavored e-cigarette and vapor products and flavored cigars from shelves of retail outlets with already small profit margins. Additionally, changes as proposed could require expensive modifications and remodeling of stores that desire to continue to sell the products. In many cases, physical limitations may make such changes impossible and threaten the profitability and viability of retail locations altogether. Now is the time for affected businesses to engage in the administrative process by submitting comments that raise questions about the guidance, communicate costly and harmful impacts that may be experienced by your business and, as requested from Zeller, specifically illustrate the measures your business takes to prioritize your efforts to comply with prohibitions on underage sales.