SBA Office of Advocacy – Roundtable on the Regulation of Premium Cigars – September 12, 2019

The U.S. Small Business Administration Office of Advocacy will hold a roundtable to discuss the regulation of premium cigars beginning at 10:00 a.m. on Thursday, September 12, 2019. The roundtable will be held in Washington, D.C., at the Small Business Administration headquarters, 409 3^rd Street SW, Eisenhower Conference Room. Send your RSVP to charles.jeane@sba.gov. Please indicate whether you will be attending in person or by teleconference. Information for attending by teleconference will be sent to you after you RSVP.

Agenda

10:00 Welcome and Introductions, Assistant Chief Counsel Charles G. Jeane

10:15 Discussion of the Food & Drug Administration’s (FDA) regulation of premium cigars

• Drew Newman, General Counsel and Cigar Maker at J.C. Newman Cigar Company
• John Anderson, Proprietor of W. Curtis Draper Tobacconist and President of Premium Cigar Association (PCA) (formerly the International Premium Cigar & Pipe Retailers Association)

Roundtable meetings are open to all interested persons, except for the press, in order to facilitate open and frank discussion about the impacts of Federal regulatory activities on small entities. Agendas and presentations are available to all, including the press.Anyone who wants to receive roundtable agendas or presentations, or to be included in the distribution list, should forward such requests to charles.jeane@sba.gov. The purpose of these Roundtable meetings is to exchange opinions, facts, and information and to obtain the attendees’ individual views and opinions regarding small business concerns. The meetings are not intended to achieve or communicate any consensus positions of the attendees.

Issue for Discussion

September 12, 2019

On March 26, 2018, the FDA published an advanced notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars. Specifically, the FDA sought comments, data, research results, and other information related to the following:  the definition of premium cigars, the use patterns of premium cigars, and public health considerations associated with premium cigars. The ANPRM’s comment period closed on June 25, 2018; over 8,700 comments were submitted.

Premium cigars have been under the FDA’s regulatory authority since the passage of The Family Smoking Prevention and Tobacco Control Act. The FDA finalized its “Deeming Rule” on May 10, 2016. The FDA determined that the Deeming Rule would have a significant economic impact on a substantial number of small entities and included a final regulatory flexibility analysis (FRFA) with the publication of the final rule. In its FRFA, the FDA determined that the Deeming Rule would impose significant costs on small businesses in the cigar industry and would likely cause some businesses to exit the market.