7-25-18: Regulation of Premium Cigars, Advance Notice of Proposed Rulemaking

July 25, 2018

 

VIA ELECTRONIC SUBMISSION

 

The Honorable Scott Gottlieb, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Re: Regulation of Premium Cigars, Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 12901 (March 26, 2018) (Doc. No. FDA-2017-N-6107).

Dear Commissioner Gottlieb:

On March 26, 2018, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking entitled: Regulation of Premium Cigars.[1] The U.S. Small Business Administration’s Office of Advocacy (Advocacy) appreciates the FDA’s solicitation for more information related to the regulation of premium cigars and welcomes the opportunity to provide input on behalf of small business stakeholders. Advocacy recommends the agency consider and explain all significant alternatives in order to minimize the significant economic impact of any proposal on small entities.

The Office of Advocacy

Congress established Advocacy under Pub. L. 94-305 to represent the views of small entities before Federal agencies and Congress. Advocacy is an independent office within the U.S. Small Business Administration (SBA); as such the views expressed by Advocacy do not necessarily reflect the views of the SBA or the Administration.  The Regulatory Flexibility Act (RFA),[2] as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA),[3] gives small entities a voice in the rulemaking process.  For all rules that are expected to have a significant economic impact on a substantial number of small entities, federal agencies are required by the RFA to assess the impact of the proposed rule on small entities and to consider less burdensome alternatives.

Background

On June 22, 2009 the Tobacco Control Act was enacted and provided the FDA with authority to regulate the manufacture, distribution, and marketing of tobacco products to “protect the public health.”[4] The Tobacco Control Act further provides that other tobacco-related products can be subject to regulation if the FDA deems them to be regulated products under a rulemaking process referred to as the “deeming regulation.”

On April 24, 2014 the FDA issued a proposed deeming regulation that would deem formerly unregulated or uncovered products subject to FDA regulation, including premium cigars.[5] On, June 11, 2014, Advocacy submitted comments on the proposed rule, citing concerns that the proposed rule’s Initial Regulatory Flexibility Act Analysis (IRFA) did not adequately consider or explain significant alternatives which could accomplish the stated FDA objectives while minimizing the significant economic impact of the proposal on small entities.[6] A copy of the letter is attached. The deeming rule became final on May 10, 2016.[7] While one of the proposed rule’s options contained an exemption for premium cigars, the final rule ultimately included premium cigars within the scope of the final rule.[8] On July 28, 2017, the FDA announced a new comprehensive plan for regulating tobacco and nicotine.[9] Pursuant to these efforts, on March 26, 2018, the FDA published an advance notice of proposed rulemaking seeking additional information related to the regulation of premium cigars.

Small Businesses are Concerned about the Impacts of Premium Cigar Regulation

In its June 11, 2014 letter, Advocacy voiced concerns the proposed deeming rule’s IRFA was deficient, and therefore the public had not been adequately informed about the possible impact of the proposal on small entities and whether there were less burdensome significant alternatives to the proposed rule that would meet the FDA’s objectives. Many of the small business concerns cited in Advocacy’s previous letter still remain – including concerns related to the cost of premarket submissions and the potentially extensive costs of complying with any regulatory proposal.

Advocacy’s Recommendations

Advocacy expects that any regulation of the premium cigar industry under the deeming rule would include a more robust economic analysis of the rule’s impact on small businesses, and a description of significant alternatives that would minimize that impact. As we pointed out in our 2014 letter, the Regulatory Flexibility Act itself provides guidance on alternatives that the FDA should consider as a minimum: (1) the establishment of different compliance or reporting requirements for small entities or timetables that take into account the resources available to small entities; (2) clarification, consolidation, or simplification of compliance and reporting requirements for small entities; (3) use of performance rather than design standards; and (4) exemption for certain or all small entities from coverage of the rule, in whole or in part.[10]

Advocacy is encouraged that FDA has taken this step to acquire information that it would need to evaluate these alternatives and the significant alternatives that have been put forward by small businesses in the industry.  Advocacy expects that in any proposed rulemaking FDA will include a full analysis of all significant alternatives and a fully explained rationale for its preferred alternative.

Conclusion

In response to the agency’s notice, Advocacy submits the above comments and resubmits its previous comments to assist the agency as it prepares its proposed rulemaking and any related RFA analysis.  Advocacy recommends that the agency consider and explain all significant alternatives in order to minimize the significant economic impact of any proposal on small entities.  If you have any questions or require additional information please contact me or the Director of the Office of Interagency Affairs, Charles Maresca, at (202) 205-6978 or by email at charles.maresca@sba.gov.

 

Sincerely,

 

 

Major L. Clark, III
Acting Chief Counsel
Office of Advocacy
U.S. Small Business Administration

Charles A. Maresca
Director of the Office of Interagency Affairs
Office of Advocacy
U.S. Small Business Administration

 

[1] See Food and Drug Admin.; Regulation of Premium Cigars, Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 12901 (March 26, 2018).

[2] See 5 U.S.C. § 601 et seq.

[3] See Pub. L. 104-121, Title II, 110 Stat. 857 (1996) (codified in various sections of 5 U.S.C. § 601 et seq.).

[4] See Tobacco Control Act of 2009 (Pub. L. 111-31) amending FD&C Act, § 901, 21 U.S.C. 387a.

[5] See 79 Fed. Reg. 23142 (April 25, 2014).

[6] See SBA Office of Advocacy, Letter re: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, Docket No. FDA-2014-N-0189 (June 11, 2014), https://www.sba.gov/advocacy/61114-deeming-tobacco-products-be-subject-f....

[7] See 81 Fed. Reg. 28974 (May 10, 2016).

[8] See id. at 29020.

[9] See Food and Drug Admin., News Release: FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death (July 28, 2017), https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm568923.htm.

[10] See 5 U.S.C. § 603(c).