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From Health Law Daily, April 24, 2014

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

By Anthony H. Nguyen, JD

In an extension of its regulatory authority from cigarettes to electronic cigarettes (e-cigarettes), the FDA proposed new regulations on April 24, 2014, 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 also fall under the expanded regulatory purview of the FDA. 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. The FDA is also asking for 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. Citing mounting evidence of public health concerns as basis for the agency’s actions, the proposed regulations are set to publish April 25, 2014, with a public comment period of 75 days.

Tobacco Control Act. Since the passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (P.L. 111-31) in 2009, regulating conventional cigarettes by amending the Food, Drug, and Cosmetic Act (FDC Act), e-cigarettes have exploded in popularity as a nicotine delivery device creating a multibillion-dollar industry with no current federal oversight or protections for consumers.

Provisions of the Tobacco Control Act grant the FDA authority to regulate cigarettes, cigarette tobacco, roll-your own tobacco, and smokeless tobacco. In addition, the FDA has “deeming” authority to subject other tobacco products to its regulations. Once a tobacco product is “deemed,” the FDA may place “restrictions on the sale and distribution of a tobacco product,” including age-related access restrictions and advertising and promotion restrictions as appropriate for the protection of the public health. The FDA issued the proposed rule to address the public health concerns associated with the use of tobacco products, specifically e-cigarettes.

Deeming authority. Section 201(rr) of the FDC Act, as amended by the Tobacco Control Act, defines the term “tobacco product” to mean “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

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 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.

Mounting e-cigarette safety concerns. As previously reported by Wolters Kluwer, electronic cigarettes have gained popularity among youth, thanks to advertisements pitched by celebrities promoting such products as fresh and healthy new alternatives to conventional cigarettes, similar to ads from the 1950s and 1960s. The Centers for Disease Control and Prevention found that calls to poison centers for e-cigarette nicotine poisoning had risen from one call per month in 2010 to over 200 calls per month in 2014.

Although FDA oversight and regulation is paramount to an effective policy on e-cigarettes, the perceived glacial pace of the agency in undertaking action regarding e-cigarettes, in light of mounting evidence as to possible harmful impact on minors, led some members of the U.S. Senate to introduce a measure that would ban advertising of e-cigarettes to children and teens. The Protecting Children from Electronic Cigarette Advertising Act (E-Cigarette Advertising Act) would “take strong action to prohibit the advertising of e-cigarettes directed at young people and ensure that the Federal Trade Commission (FTC) can take action against those who violate the law.”

Following up with both the FDA and FTC, the senators noted in a strongly worded letter that lack of e-cigarette regulations had created a vacuum that permitted manufacturers to market nicotine products to youth and “risk addicting a new generation to nicotine.” Last week, Wolters Kluwer reported on an investigation by members of the Senate and House into the practices of nine frequently sold e-cigarette brands, finding that the e-cigarettes were promoted and offered as free samples at youth-oriented events.

Prior to today’s announcement, over 28 states had already undertaken action to ban or restrict either the sale or public usage of e-cigarettes, along with several cities such as New YorkLos Angeles, and Chicago.

Anti-smoking advocates have expressed some concerns that the FDA is also asking for 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, as well as the proposed regulations lack of an outright ban on e-cigarette flavors.

Commenting today on the FDA’s new proposed regulations, Senator Tom Harkin (D-IA), an original sponsor of the E-Cigarette Advertising Act, applauded the agency for its actions and urged the FDA “to keep their foot on the gas and take strong action towards ensuring that [e-cigarettes] are kept out of the hands of young people,” as well as ensure that the eventual final rule contains prohibitions against candy flavors, such as grape or bubblegum, used to entice minors to use nicotine products.

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