Congress Seeking to Limit FDA Authority Over Premium Cigars

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A number of U.S. Representatives on both sides of the aisle recently cosponsored a proposed bill that would limit the U.S. Food & Drug Administration’s (FDA’s) ability to regulate premium cigars. Although the text of the proposed House bill has not yet been published, a similar bill proposed in the Senate on February 24, 2021 would prevent FDA from regulating “traditional large and premium cigars,” which would be defined as:

(i) any roll of tobacco that is wrapped in 100-percent leaf tobacco, bunched with 100-percent tobacco filler, contains no filter, tip or non-tobacco mouthpiece, weighs at least 6 pounds per 1,000 count, and—

(I) has a 100-percent leaf tobacco binder and is hand rolled;

(II) has a 100-percent leaf tobacco binder and is made using human hands to lay the leaf tobacco wrapper or binder onto only one machine that bunches, wraps, and caps each individual cigar; or

(III) has a homogenized tobacco leaf binder and is made in the United States using human hands to lay the 100-percent leaf tobacco wrapper onto only one machine that bunches, wraps, and caps each individual cigar; and

(ii) does not include a cigarette (as such term is defined by section 900(3)) or a little cigar (as such term is defined by section 900(11)).

Passage of either bill would be significant win for the premium cigar industry, which has long sought to distinguish itself from those in the industry that sell other tobacco products. Versions of these bills have been proposed in prior years.

FDA has broad authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act of 2009 (the Tobacco Control Act or the TCA). The TCA granted FDA explicit statutory authority to regulate the manufacture, distribution, and marketing of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

In addition, the TCA granted FDA authority to regulate any other tobacco products it deems necessary to implement the TCA. In 2016, FDA relied on this power to promulgate the so-called “Deeming Rule,” in which, among other things, FDA determined that premium cigars would be subject to regulation under the TCA. Opponents to FDA’s regulation of premium cigars argued, in part, that such regulation would impose excessive costs and burdens on small businesses; premium cigars are unique in how they are made, marketed, sold, purchased, and used; and premium cigars present much lower health risks than other tobacco products. See 81 Fed. Reg. 28974, 29026-27 (May 10, 2016). Nevertheless, FDA decided to regulate premium cigars.

As noted in a previous blog post, FDA is still studying how to best regulate premium cigars and has run into other legal challenges otherwise delaying certain requirements for premium cigars. As such, any new legislation that would limit FDA’s power to regulate premium cigars would be a welcome change for the premium cigar industry and, therefore, the proposed House and Senate bills should be closely monitored by stakeholders.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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