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10 SMOKESHOP December 2015 E. Edward Hoyt III Editor & Associate Publisher Lily Coleman Art Director YiLing Yen Assistant Art Director Melinda Ayala Production Coordinator Zachery Bridgeman Editorial Assistant Thomas Briant Editorial Contributors Bryan Haynes Ron Maltin Craig Williamson LOCKWOOD TRADE JOURNAL CO., INC. Robert Lockwood President & Publisher Frederick Lockwood Vice President Rob Lockwood Executive Director Jamie Wolberg Events/Circulation Manager Roxanne Cordova-Melendez Accountant Yvonne Viruet Receptionist SMOKESHOP MAGAZINE Lockwood Trade Journal Co., Inc. 3743 Crescent Street, 2nd Floor Long Island City, NY 11101 Tel: (212) 391-2060, Fax: (212) 827-0945 Website: www.smokeshopmag.com Editorial submissions: Send new product announcements, corporate news, calendar events, letters to the editor, or story ideas to The Editor, editor@smokeshopmag.com SMOKESHOP (ISSN 0146-9266 print edition; ISSN 2331-8562 online digital edition), established in 1970, is published bimonthly (February, April, June, August, October, and December) by Lockwood Trade Journal Co., Inc., 3743 Crescent St., 2nd Floor, Long Island City, NY 11101 U.S.A. Postage paid at New York, NY and at additional mail- ing offices. Annual sub scrip tion rates: United States, $24; Canada, $34; all other countries $49 by surface or $69 by airmail, payable in advance. Copyright ©2015 by Lockwood Trade Journal Co., Inc. The contents of SMOKESHOP, and all articles, illustrations, photos, etc. are copyrighted and may not be reprinted except by permission. CPC agreement number 1477773. POSTMASTER: Please send all address changes to SMOKESHOP Magazine, P.O. Box 385, Congers, N.Y. 10920-9985 Single Issue: US$15 T H E I N D U S T RY A U T H O R I T Y O N T O B A C C O R E TA I L I N G Official Publication of the International Premium Cigar & Pipe Retailers Association Member: International Premium Cigar & Pipe Retailers Association (IP- CPR); National Association of Tobacco Outlets (NATO); Tobacconists' Association of America (TAA); Cigar Rights of America (CRA). LETTER Editor's More Waiting as the OMB Reviews FDA's Proposed Final Ruling of Deeming Regulations T he U.S. Food & Drug Administration (FDA) submitted its proposed final ruling of deeming regulations (enabling the agency's regulatory control over cigars, pipe tobaccos, and vaping products) to the White House Office of Management and Budget (OMB) on Oct. 19, 2015. The agency allots up to 90 days to review such documents, but it's not a binding time frame and the agency has often takes an additional 30 days to make necessary changes in the interests of balancing the economic impact of the proposed regulations. It's the second-to-last step in the FDA's process of implementing regulatory control over these categories, followed only by final publication in the Federal Register. Deeming regulations would become effective 30 days after the date of publication. The published rule can incorporate changes that the OMB sees fit to make, including the crucial "Option 1" vs. "Option 2" decision on premium cigars. (For a complete look at the remaining process, and the ramifications of the decisions the OMB can still make, see "Final Steps for the FDA Deeming Regulations," by Thomas Briant, Executive Director of NATO, Page 52). The OMB's final say is now more crucial than ever, following the industry's failure to secure the inclusion of two heavily lobbied legislative riders in the House of Representative's omnibus appropriations bill unveiled on December 15. The first, was a very specific definition of, and proposed exemption for, premium cigars from FDA regulation. The second was a change to the FDA's grandfather date of Feb. 15, 2007, the threshold that will determine which currently existing cigar, pipe tobacco, and vaping products will be exempt from regulation. The fact that neither industry supported rider made the final draft brought to light the full extent of the industry's division regarding the exemptions. The industry was united in supporting the date change rider, which would have moved the grandfather date forward to the yet-to-be- determined date of effectiveness of the deeming regulations themselves. Such a move would grandfather thousands of currently marketed products; without the date change, manufacturers of any new products brought to market after Feb 15, 2007 would have to gain FDA permission to keep them on the market. There are two, still largely untested "pathways" to market: The first is for the FDA to determine that the product is "substantially equivalent" with the same characteristics as a predicate tobacco product (or if differs, no new health questions are raised). For products that weren't already being marketed by Feb. 15, 2007—essentially the entire vaping industry— manufacturers would need to submit a premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations. To date, only one company has successfully negotiated this pathway under rules in place for cigarettes and smokeless tobacco, Swedish Match (see XXX, Page XXX). The rider seeking a complete exemption for premium cigar regulation was controversial within the tobacco industry, however, with mass market cigar makers joining forces to warn premium cigar interests that lobbying for the rider could actually harm the likelihood of winning the grandfather date change. E. Edward Hoyt III