WASHINGTON, D.C. – Ahead of some of the most sweeping changes to rules governing cigars and e-cigarettes, industry groups and health advocates have been bending the ear of the White House to press their suggestions, The Hill reports. The Office of Management and Budget (OMB) is conducting a final review of the new regulations, which move cigars and e-cigs under the U.S. Food and Drug Administration (FDA) for the first time.
Thus far, 21 meetings have been held to talk about the deeming rule, with another dozen or so on the books for December. This means that the new rules will likely not be ready until 2016. Tobacco and electronic cigarette industry representatives constitute the bulk of the meetings, especially because of a potential “grandfather date” for e-cigs in an earlier version of the rules. The proposed rules say that any tobacco product first on the shelves after February 15, 2007, would need to retroactively apply for FDA approval.
“If these rules went through, the only ones left standing would be big tobacco—what you see in convenience stores,” said Schell Hammel of The Vapor Bar Inc., which has seven retail locations. She told OMB that small “vape” shops like hers would have to pay millions of dollars for the required testing for agency approval.
Meanwhile, health advocates have pushed for release of the rules sooner. “E-cigarette manufacturers have been on notice since at least 2011 that FDA planned to regulate their products, but they have taken advantage of the delay in regulation to introduce kid-friendly flavors, and now they want to limit FDA review of those products, which we think is absurd,” said Vince Willmore, vice president of communications for the Campaign for Tobacco-Free Kids.
However, the debate centers more on who has the power to change the grandfather date: the administration, or an act of Congress? The FDA has noted it lacks the authority to do so because the date was set in the Family Smoking Prevention and Tobacco Control Act of 2009.
In March of 2014, NACS issued a statement of position to encourage stores selling e-cigarettes to adopt, as a best practice, a policy of treating these products as age restricted and subjecting them to the same age-verification procedures as those applicable to tobacco products.