John Anderson, President Scott Pearce, Executive Director Greg Zimmerman, Vice President Phone: 202-849-6042 Scott Regina, Treasurer www.ipcpr.org Todd Naifeh, Secretary
[email protected] Ken Neumann, Ex-Officio 513 Capitol Court Washington, DC 20002 July 17, 2019 SUBMITTED VIA REGULATIONS.GOV Division of Dockets Management HFA-305 Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Comments of the International Premium Cigar and Pipe Retailers Association on Docket No. FDA-2016-N-3818: “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports.” Dear Sir or Madam: The International Premium Cigar and Pipe Retailers Association (IPCPR), which as of June 2019 is now known as the Premium Cigar Association, submits their comments to the Food and Drug Administration (FDA) on the Agency’s proposed rule establishing requirements for the content and format of tobacco product substantial equivalence (SE) reports (Proposed Rule).1 The IPCPR is an not-for-profit trade group representing premium cigar retail shops located throughout the United States and abroad. IPCPR members operate more than 2,500 retail stores and employ more than 14,000 people. 1 U.S. Food & Drug Admin., Proposed Rule: “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports,” 84 Fed. Reg. 12,740 (April 2, 2019) (available at https://www.federalregister.gov/documents/2019/04/02/2019-05787/content-and- format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on). The IPCPR appreciates the opportunity to provide comments and data to the agency regarding whether and how the substantial equivalence process should apply to premium cigars.