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E-Cigarettes, Other Tobacco Products Would be Subject to FDA Regulation Under Long-Awaited Proposal

Friday, April 25, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued an extensive proposed rule that would expand the agency’s regulatory authority to additional tobacco products, including electronic cigarettes and items that may be developed in the future. FDA is also proposing to prohibit the sale of regulated tobacco products to individuals under the age of 18 and to require the display of health warnings on packages and in advertisements. Comments on this proposal are due no later than July 9.

Covered Items. The proposed rule includes two options for expanding the types of tobacco products covered by FDA regulation, which currently include cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Option 1 would establish as products deemed to be subject to FDA regulation those that meet the statutory definition of a tobacco product, including e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority. Option 2 would expand coverage to all such items other than premium cigars. In either case, accessories of covered products (e.g., hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers and lighters) would not be regulated.

Components and parts of tobacco products that would be subject to regulations under this proposed rule 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. Examples include air/smoke filters, tubes, papers, pouches or flavorings (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes.

The proposed rule would also deem any future tobacco products that meet the statutory definition of “tobacco product” (except accessories) to be subject to FDA regulation; e.g., tobacco products that provide nicotine delivery (e.g., via dermal or buccal absorption) similar to currently marketed medicinal nicotine products but that are not marketed for therapeutic purposes.

Requirements. Manufacturers of newly deemed tobacco products would have to register with the FDA, list their products, and report ingredients as well as harmful and potentially harmful constituents. They would only be allowed to market new tobacco products after FDA review and to make direct and implied claims of reduced risk (e.g., “light” or “low”) if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole. No free samples could be distributed, and enforcement action could be taken against covered products determined to be adulterated or misbranded.

The proposed rule would also impose the following requirements on all covered tobacco products: minimum age and identification restrictions to prevent sales to underage youth, health warnings on packages and advertisements (including for cigarettes and roll-your-own tobacco), and a prohibition on vending machine sales, unless in a facility that never admits youth.

The deeming provisions and age restrictions would be effective 30 days from the date of publication of a final rule. The proposed health warning requirements would be effective 24 months after the final rule is issued. In addition, manufacturers could continue to introduce into domestic commerce existing inventory that may not contain the warning statements required under the final rule for an additional 30 days after the health warnings take effect.

Comments. While all comments, data, research and other information submitted will be considered, the FDA is specifically requesting comments on the following issues.

- whether all cigars should be subject to “deeming” and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars

- the characteristics or other factors that should be considered in determining whether a particular tobacco product is a cigarette and thus subject to the prohibition against characterizing flavors

- how products that do not involve the burning of tobacco and inhalation of its smoke (such as e-cigarettes) should be regulated

- whether the FDA should define components and parts of tobacco products and how those items might be distinguished from accessories

- whether the FDA should stagger the compliance dates for certain provisions for different categories of products

- whether all tobacco products should be required to carry an addiction warning and, if so, whether different warnings should be placed on different categories of products

For more information on the FDA proposal, or for assistance preparing comments, please contact Deb Stern at (305) 894-1007 or Arnie Friede at (305) 894-1033.

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