SS June 2016

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June 2016 SMOKESHOP 37 37 SMOKESHOP June 2016 Retailers that mix or prepare pipe to- bacco blends will have to report to the FDA each pipe tobacco blend that they sell. The retailer will be responsible, as a regulated manufacturer, to determine which products they plan to manufac- ture. For shops that prepare a number of custom pipe tobacco blends, with many gradations of flavor, nicotine strength, or other characteristics, the FDA would require the retailer to identify, list, and report ingredients for each of the dis- tinct products. A tobacco store retailer that purchas- es tobacco in a bulk package, empties the bulk package contents into display jars, and then sells pipe tobacco by the ounce in plastic bags could be consid- ered a manufacturer under a literal in- terpretation of the deeming regulations because the pipe tobacco is being "re- packaged." However, a major bulk pipe tobacco manufacturer, Scandinavian To- bacco Group Lane, is developing a posi- tion paper advocating that manufactur- er regulations should not be extended to retailers that only buy bulk pipe tobacco and sells the tobacco—without blend- ing—in smaller bags. In the deeming regulations, the FDA lists two options for retailers that mix nicotine e-liquids for use in electronic cigarettes. While not specifically stated, these same two options should be avail- able to retailers that blend pipe tobacco. First, a retailer should be able to con- tinue to sell the same pipe blends that it mixes as of August 8, 2016 for up to an additional 24 months without submit- ting either a SE or a PMTA application. The FDA announced in the deeming reg- ulations that the agency does not intend to enforce the SE or PMTA application requirements for this 24-month period to provide more time for retailers to com- pile and submit the appropriate appli- cations. However, the retailer must stop selling the blended pipe tobaccos at the end of the 24-month compliance period if no SE or PMTA applications are filed for blends mixed by the retailer or be subject to FDA enforcement actions. Second, if the retailer prepares and submits SE and/or PMTA applications during the 24-month period following August 8, 2016 for pipe tobacco blends that it mixes, the retailer can sell the blends during the 24-month period plus another 12-month period while the FDA reviews the applications. At the end of this 36-month period, and even if the re- tailer has SE and/or PMTA applications pending with the FDA, the continued sale of the pipe blends covered by a SE or PMTA application are subject to en- forcement action by the FDA unless the agency has approved the applications. The decision of a retailer to file or not file SE or PMTA applications does not relieve the retailer from complying with the other manufacturer registration and product listing requirements. NOT THE FINAL WORD: FUTURE TOBACCO PRODUCT REGULATIONS According to the FDA, the final deem- ing regulations differ from most public health regulations in that they are en- abling regulations. In addition to directly applying the substantive requirements of the TCA and its implementing regula- tions to newly deemed tobacco products, the deeming regulations enable the FDA to issue further regulations related to to- bacco products that are appropriate for the protection of the public health. Although the deeming regulations do not ban self-service displays of the deemed tobacco products, the FDA will continue to monitor this issue and, if it determines that it is appropriate for the protection of public health to extend the self-service display prohibition to newly deemed tobacco products, the agency will issue a new proposed rule to do so. In response to industry comments, the FDA clarified that it is not banning flavored tobacco products with this final deeming rule. However, to address con- cerns with the growing flavored cigar market and its impact on youth and young adult initiation with tobacco products, the FDA states in the deeming regulation that it intends in the future to issue a proposed product standard that, if finalized, would eliminate characteriz- ing flavors in all cigars including cigaril- los and little cigars. Thomas Briant is executive director of the National Association of Tobacco Outlets (NATO), Toll-free: (866) 869-8888, Web: > Above: J.M. Boswells Handmade Pipes of Chambersburg, Pa. hand blends over 30 variet- ies of pipe tobaccos, sold by the ounce or in tins. Retailers of custom-blended pipe tobac- cos face a daunting future since they meet the definition of a tobacco products manufactur- er under the Tobacco Control Act, subject to costly and complicated regulatory requirements.

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