Deem the e-Cigarettes! Full Speed Ahead!

By David B. Clissold –

Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), the Food and Drug Administration (“FDA”) was given the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.  Other “tobacco products” could be regulated by FDA only if the agency issued regulations “deeming” such other products to be subject to the Tobacco Control Act.  Last week, the agency issued the much anticipated proposed deeming regulations that would cover electronic cigarettes (“e-cigarettes”), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and certain dissolvable tobacco products.
 
FDA proposed two options for regulating these products.  Under Option 1, FDA would extend its “tobacco product” authorities to all of the products (except accessories of a proposed deemed tobacco product), that meet the statutory definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act (“FDC Act”).  Section 201(rr) of the FDC Act, as amended by the Tobacco Control Act, defines the term “tobacco product” very broadly as “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).”  Option 2 of the proposed rule is identical to Option 1, except that it would exempt “premium cigars” from regulation.

Under the proposed rule, makers of newly deemed tobacco products would be subject to the following:

• Enforcement action against products determined to be adulterated and misbranded;
• Required submission of ingredient listing and reporting of harmful and potentially harmful constituents (“HPHCs”);
• Required registration and product listing for all tobacco products;
• Prohibition against use of “modified risk” descriptors (e.g., “light”) and claims unless FDA issues an order permitting their use;
• Prohibition on the distribution of free samples; and
• Premarket review requirements.

79 Fed. Reg. 23,142, 23,143 (Apr. 25, 2014).  In addition, FDA proposed that the following provisions of the Tobacco Control Act would also apply to newly “deemed” tobacco products:

• Minimum age and identification restrictions;
• Required health warnings; and
• Prohibition of vending machine sales.

79 Fed. Reg. 23,142 (Apr. 25, 2014).  Throughout the proposed rule, FDA requested public comment on numerous tobacco control issues, including:

• Whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars;
• Information related to many public health questions related to e-cigarettes such as the co-use of e-cigarettes with more traditional tobacco products and the effects of e-cigarettes on the initiation and continuation of use of other tobacco products; and
• Comments about any unique challenges faced by small manufacturers of proposed deemed tobacco products and how they should be addressed.

Id.  FDA did not act to ban flavors in these newly deemed products at this time, although it is continuing to study the issue.  Nor did FDA attempt to regulate internet or mail order sales of tobacco products through this proposed rule.  Further, FDA determined that it did not have the authority to change the “predicate product” date of February 15, 2007.  That date is important because a product may only use the “substantial equivalence” (“SE”) pathway to market if that product is similar to a product commercially marketed in the U.S. as of February 15, 2007.  If no such predicate product exists, the product must be submitted for approval under the more burdensome premarket tobacco application (“PMTA”) process.  However, the proposed rule also deems any future tobacco products that meet the statutory definition of “tobacco product” to be subject to FDA’s authorities.

Under the proposed rule, the deeming provisions and age restrictions would become effective 30 days from the date of publication of the final rule.  The proposed health warning requirements would become effective 24 months after the final rule is issued. FDA also proposed a 24-month compliance period for the submission of SE reports and PMTAs.  Further, if a manufacturer submits a PMTA or SE application for its affected products within the 24-month time frame, FDA would not initiate action against those products for failing to have a marketing authorization until it had responded to the application.

FDA established a 75-day comment period for public input on this proposed rule.  In future blogposts, we will take a closer look at some of the provisions of these deeming regulations.