FDA issued the long-awaited deeming regulation this morning. With respect to cigars, FDA proposed two options for the scope of the rule. FDA is requesting comments on the two options, and comments must be submitted within 75 days of the issuance of the proposed rule.
Under the first option, FDA proposes to extend its authority to all products that meet the definition of “tobacco products,” except the accessories of such products. The Tobacco Control Act defines “tobacco products” 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.” If this proposal is approved, all cigars, including small, large and premium cigars, will be regulated by FDA.
Under option two, the proposed rule would not include all cigars. In order to be exempt from regulation, a cigar must meet eight requirements. These requirements are that the cigar:
1) Is wrapped in whole tobacco leaf;
2) Contains a 100 percent leaf tobacco binder;
3) Contains primarily long filler tobacco;
4) Is made by combining manually the wrapper, filler, and binder;
5) Has no filter, tip, or non-tobacco mouthpiece and is capped by hand;
6) Has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment);
7) Does not have a characterizing flavor other than tobacco; and
8) Weighs more than 6 pounds per 1000 units.