US FDA’s proposed rules to ban menthol cigarettes and flavored cigars are out, but may still take years before they come into effect.
The US Food and Drug Administration (FDA) issued its proposed rules to ban menthol cigarettes and flavored cigars. However, FDA may allow some exemptions on a case-by-case basis for products such as heated tobacco devices or very low nicotine cigarettes. Menthol e-cigarettes are not covered by this ban.
The public can comment on these proposed rules starting on May 4, when the proposed rules will be published as proposed regulation in the Federal Register and will be open for public comments for at least 60 days. FDA will also convene public listening sessions on June 13 and June 15 where individuals, communities, and organizations can share their perspectives with FDA. In addition, the public will be able to submit electronic or written comments directly to the dockets on the proposed rules through July 5. It is expected that the ban will still take years to come into effect, as FDA would still need to review all the comments, publish the final rules, and possibly deal with legal suits.
“We strongly believe that there are more effective routes to deliver tobacco harm reduction than banning menthol in cigarettes,” said Kingsley Wheaton, British American Tobacco’s chief marketing officer, in a statement. “Evidence from other markets, including Canada and the EU where similar bans have been imposed, demonstrates little impact on overall cigarette consumption.”
“Prohibition, at least through history, hasn’t worked,” said Altria c.e.o., Billy Gifford, adding that federal regulators should focus instead on helping smokers switch to lower-risk products such as e-cigarettes.
“FDA failed to do their homework in this rule and the document is filled with cherry-picked data that mirrors spoon-fed talking points from anti-tobacco groups,” said Greg Zimmerman, president of the Premium Cigar Association (PCA). “The proposed rule is a mess that is ripe with potential challenges and reflective of an agency that is unable to prioritize its resources appropriately.”
PCA was the first stakeholder group to meet with the Office of Management & Budget, Office of Information & Regulatory Affairs, and Food & Drug Administration on March 10 to raise concerns about the pending rule, ask for clarification on the specifics, and make recommendations about further research on international implications and impact on small businesses. PCA asserts that the agency still has left many questioned unanswered specifically on characterizing flavor descriptors, total small business impact, foreign impact in cigar producing countries, and impact on minority-owned small businesses.
“The overall public health community has increasingly supported a posture of allowing citizens to make their own informed health decision," said a statement from Swisher, manufacturer of Swisher Sweets Cigars. "This FDA action, however, does the opposite. It restricts consumer choice and removes adult products from the market without scientific basis for doing so. FDA should suspend action on a flavor standard for cigars until further study is done on the manner of use of various types of cigars and its implications. Adult cigar consumers should be empowered to weigh the evidence and risk as that information emerges and make fully educated choices.”