Understanding the FDA’s Flavor Focus

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    Menthol in Combustible Tobacco Products
    The agency’s announcement also stated that the FDA intends to issue a proposed regulation with a product standard that would ban menthol in combustible tobacco products, including cigarettes and cigars. Again, this proposal would need to follow a nine-step regulatory process before new regulations banning the use of menthol in cigarettes and cigars would go into effect.

    Regulation Process
    As indicated above, the FDA must follow a nine-step process when proposing a new regulation. That process includes drafting the regulation, obtaining an initial review and approval of the proposed regulation by the White House’s Office of Management and Budget, requesting comments from the public and the industry on the proposed regulation, reviewing all of the comments submitted, considering amendments to the proposed regulation based on the comments, obtaining final review and approval of the regulation from the Office of Management and Budget, publishing the final regulation, and setting an effective date for the regulation. This entire process takes time, potentially up to several years. In addition, there could also be litigation after a final regulation is adopted that would seek to overturn a new product standard or other kind of restriction.

    This story first appeared in the January/February 2019 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas A. Briant, executive director of the National Association of Tobacco Outlets (NATO)