By Charles Jeane, Assistant Chief Counsel
On August 19, 2020, the United States District Court for the District of Columbia issued a Memorandum Opinion and Order enjoining the Food and Drug Administration (FDA) from enforcing its premarket review process on the premium cigar industry and remanding the “Deeming Rule” to the agency for the limited purpose of considering whether a streamlined Substantial Equivalence (SE) process is appropriate for premium cigars. The Court found that the FDA failed to meaningfully respond to public comments abouts alternatives to the SE process. The Court stated that the agency’s response to public comments was “cursory” and not “reasoned decision-making” because the FDA mischaracterized commenters’ suggestions and incorrectly implied that it did not have the authority to adjust SE requirements for premium cigars.
On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was signed into law, giving the FDA the authority to regulate the manufacturing, marketing, and distribution of tobacco products. Under the Act, tobacco products include “cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and … any other tobacco products that the Secretary by regulation deems to be subject to this chapter.”[1] On May 10, 2016, the FDA published the final Deeming Rule, which deemed cigars, pipe tobacco, and certain other products, e.g., e-cigarettes, to be tobacco products subject to the Tobacco Control Act.
The FDA’s Deeming Rule and its premarket tobacco application process were problematic for small businesses before the rules were even written, and the Office of Advocacy has been working with the premium cigar industry on issues surrounding the rule since the Tobacco Control Act was passed. Advocacy has written comment letters to the agency, held a roundtable to discuss how the Deeming Rule will impact small premium cigar businesses, and helped stakeholders make their arguments to the FDA and policy makers on Capitol Hill. On April 5, 2019, Charles Maresca, Director of Interagency Affairs for the Office of Advocacy, testified at the Senate Committee on Small Business and Entrepreneurship field hearing “Keeping Small Premium Cigar Businesses Rolling” in Tampa, Florida.
On March 26, 2018, the FDA published in the Federal Register the advance notice of proposed rulemaking Regulation of Premium Cigars.[2] No further action has been taken on that rulemaking. And on April 2, 2019, the agency published the proposed rule Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports in the Federal Register.[3] To date, that rule has not been finalized.
The District Court’s order can be read here.
[1] 21 U.S.C. § 378a(b) (2009).
[2] 83 Fed. Reg. 12,901 (March 26, 2018).
[3] 84 Fed. Reg. 12,740 (April 2, 2019).
Charles Jeane is an Assistant Chief Counsel for Advocacy whose portfolio includes tax policy. Charles can be reached at Charles.Jeane@sba.gov.