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From Products Liability Law Daily, April 25, 2014

E-cigarette regulations would ban sales to minors, require health warnings

By Anthony H. Nguyen, J.D.

Extending its regulatory authority from cigarettes to electronic cigarettes (e-cigarettes), the Food and Drug Administration (FDA) proposed new regulations that would ban the sale of e-cigarettes to children and teens under 18 years of age. Photo identification as proof of age would be required in order to purchase e-cigarettes. In addition to the ban of e-cigarette sales to minors, pipe tobacco such as hookahs (water pipes) would fall under the expanded regulatory purview of the FDA. Under the proposal, the FDA also would revisit the issue of the display of health warnings on cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages in advertisements. In addition, the agency is requesting public comment on whether premium cigars—hand-rolled with a tobacco leaf as a wrapper—should be placed in a special separate category not subject to the FDA’s authority. Mounting evidence of public health concerns was noted as the basis for the agency’s actions issued in an advance release on April 24, 2014. Public comments will be accepted for a period of 75 days (Proposed rule, 79 FR 23141, April 24, 2014).

Tobacco products. The FDA outlines two options in the newly proposed rule to extend its authority over “tobacco products.” Option 1 would deem "tobacco product" authorities in the Federal Food, Drug, and Cosmetic Act (FDC Act) to include all other categories of products, except accessories of a proposed deemed tobacco product that meet the statutory definition of "tobacco product" in the FDC Act. Option 2 would deem “tobacco product" authorities to include all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of "tobacco product" in the FDC Act.

The FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product. In addition, the FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product. Therefore, items such as hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers, and lighters would be considered accessories and would not fall within the scope of the proposed rule.

Although accessories of deemed tobacco products are excluded from the proposed rule, non-accessory components and parts of tobacco products would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product, including air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes.

Any future tobacco products that meet the statutory definition of “tobacco product,” except accessories of such product, would also be deemed to be subject to FDA's authorities. For example, the FDA noted that there could be tobacco products developed in the future that would provide nicotine delivery (e.g., via dermal or buccal absorption), similar to currently marketed medicinal nicotine products, but which are not marketed for therapeutic purposes. Such products would be “tobacco products” and subject to FDA's authority should the deeming provision of the proposed rule be finalized.

Products deemed under the proposal would be subject to the same FDC Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, including: (1) enforcement action against products determined to be adulterated and misbranded; (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (3) required registration and product listing for all tobacco products; (4) prohibition against use of modified risk descriptors and claims, such as “light,” “low,” and “mild,” unless the FDA issues an order permitting their use; (5) prohibition on the distribution of free samples; and (6) premarket review requirements.

MainStory: TopStory IndustryNewsStory ProposedRules TobaccoProductsNews

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