Tuesday, April 29, 2014

FDA Regulation: Defining E-Cigarettes As Tobacco Products

The FDA released a proposed rule to regulate “products that meet the statutory definition of ‘tobacco products’ …such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco.” 

Media reports have primarily focused on the rule’s impact on e-cigarettes.  The FDA would ban sales to youths, allow flavorings and set a two-year timeframe for approval of existing products. 

The proposed regulation, a complex 241-page document, raises fundamental questions, including: What e-cigarette components are subject to regulation as tobacco products? 

Page seven of the draft rule states that 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.’”

Is the entire e-cigarette, including the liquid cartridge, heating element, battery and mouthpiece/switch, subject to regulation, or only the liquid and only if it contains nicotine? 

I believe the FDA could exert regulatory authority over e-liquids containing nicotine, but not over other e-cig components.  There is language in the draft rule supporting this: “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 this proposed rule.” 

The most relevant accessory named in this list is “lighters.”  The FDA does not regulate matches or butane lighters as tobacco products.  These accessory items are necessary in order to consume cigarettes, cigars or pipe tobacco, but they are not tobacco products per se.  The case could be made that all of the e-cig hardware – minus the liquid – is the equivalent of a match or lighter, and thus not subject to FDA regulation as a tobacco product. 

What about the Tobacco Control Act’s reference to “any component, part, or accessory of a tobacco product”?  I don’t believe that applies to e-cig hardware, but rather to the water, propylene glycol or glycerin, and any flavoring in e-cig liquids.  Again, language in the draft rule supports this interpretation: “Such examples would include 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.”  These components are used or consumed along with the tobacco. 

This might appear to be splitting hairs, but defining precisely what parts of e-cigarettes are subject to regulation under the Tobacco Control Act has huge implications.  If nicotine e-liquids are regulated tobacco products, manufacturers will be able to file market approvals based on substantial equivalence to liquids that were on the market in 2007.  In addition, they would have considerable flexibility to continue innovation and product development of hardware components, subject only to less-burdensome consumer safety standards.  Finally,  nicotine-containing e-liquids are the only component of e-cigarettes that would qualify for tobacco excise taxes.

Defining nicotine e-cigarette liquid as a tobacco product will bring clarity to the FDA deeming regulation, provide a basis for implementing unambiguous tobacco excise taxes, and promote innovation and product development. 

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