SS June 2016

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30 SMOKESHOP June 2016 equivalence pathway is limited because it only applies to additive changes. PREMARKET REVIEW AS APPLIED TO THE NEWLY DEEMED PRODUCTS The premarket review process is certain to be more burdensome for the new- ly-deemed products. Significantly, the Tobacco Control Act's February 15, 2007 "grandfather" date will apply to the newly deemed products. As a result, the e-cigarette industry may be foreclosed from using the substantial equivalence or exemption from substantial equiv- alence pathways because e-cigarettes were not widely available in 2007 and today's products are markedly different from products sold in 2007. Although the FDA did not foreclose the possibility of "cross-category" comparisons—for ex- ample comparisons between e-cigarettes and grandfathered cigarettes—the FDA's commentary in the deeming regulations certainly discouraged such comparisons. Moreover, there will be no "provi- sional" window for the newly deemed products. Upon the regulations' August 8, 2016 effective date, every product must undergo premarket review by the FDA before it is introduced. Only those products that have been introduced be- fore August 8 can continue to be market- ed, and only so long as the manufacturer submits an exemption from substantial equivalence report by August 8, 2017, a substantial equivalence report by Febru- ary 8, 2018, or a PMTA by August 8, 2018. Finally, and perhaps most signifi- cantly, the manufacturer now bears the burden of the FDA's regulatory inertia. That is because unless the FDA acts on the manufacturer's application with- in a year, the manufacturer's products are subject to enforcement action. This stands in stark contrast to the current process, whereby the manufacturer's provisional products can continue to be sold unless and until the FDA acts. The FDA has been notoriously slow to rule on premarket review submissions; the FDA has not ruled on the vast majority of ap- plications more than five years after they were filed. In light of this track record, it is hard to imagine the FDA ruling on most submissions within a year. The premarket review process will also have a unique impact on certain businesses that manufacture the newly deemed products. Manufacturers that provide bespoke products, for exam- ple the vape shops that prepare custom e-liquids, the cigar manufacturers that produce limited and special edition re- leases, and the pipe tobacco retailers that prepare blends on-site, will likely have to cease these practices because each and every custom product would need to un- dergo premarket review. The premarket review costs—which generally exceed several thousand dollars and could be in the millions for a PMTA—likely would not be justified for limited releases or custom products. The industry has learned a great deal about the FDA's tobacco product pre- market review process during the last five years. This experience should some- what shorten the learning curve as the industry prepares to engage in this pro- cess for the newly deemed products. Un- fortunately, in light of the way the FDA has decided to apply the premarket re- view requirements to the newly deemed products, manufacturers of these prod- ucts are likely to have a much more diffi- cult time navigating that process. Troutman Sanders Tobacco Team, Troutman Sanders LLP, 1001 Haxall Point, Richmond, Va. 23219, Tel: (804) 697-2206, Fax: (804) 697-1339, Web:, Email: > Unless the FDA acts on a manufacturer's premarket tobacco application within a year, the manufacturer's products are subject to enforcement action. REGULATION FOCUS > Premarket Tobacco Application: What's Required? FDA's Center for Tobacco Products estimates that conducting the necessary scientific investi- gations and preparing a premarket tobacco application would take 5,000 hours. This estimate includes the time to conduct a chemical analysis and any necessary nonclinical or clinical studies, though it is possible that based on existing studies, an applicant may not need to con- duct any new nonclinical or clinical studies. Required information includes, but isn't limited to: • Full reports of all information, published or known to (or which should reasonably be known to) the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobac- co products; (Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demon- stration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them); • A full statement of the tobacco product's components, ingredients, additives, properties, an principle(s) of operation; • A full description of the methods used in, and the facilities and controls used for, the manu- facture, processing, and, when relevant, packing and installation of, such tobacco product; • An identifying reference to any tobacco product standard, under Section 910(b)(1) of the FD&C Act, which would be applicable to any aspect of such tobacco product, and either ade- quate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard; • Samples of the product and its components, as the Secretary may reasonably require; • Samples of the product's proposed labeling;

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