FDA Moves To Restrict Sales of Flavored Cigars

FDA Moves To Restrict Sales of Flavored Cigars

The U.S. Food and Drug Administration is taking aim at flavored tobacco products, putting flavored cigars in the target as well. Today, the organization announced a new draft guidance that seeks to restrict the sale of some flavored cigars, and the FDA will be moving forward with a proposal that would “ban all characterizing flavors in cigars.” The proposed restrictions may affect such popular flavored cigar brands as Drew Estate’s Acid and Rocky Patel’s Java.

The announcement, which came from outgoing commissioner Dr. Scott Gottlieb, was part of a broader series of new proposed rules designed to limit youth access to flavored tobacco, including e-cigarettes.

According to the new guidance, any flavored cigar that was on the market on August 8, 2016, and has not been cleared by the FDA, or grandfathered, would be affected. A grandfathered tobacco product is one that has been commercially marketed in the United States as of February 15, 2007, which is the day that the Family Smoking Prevention and Tobacco Control Act was first introduced to Congress.

In his announcement, Gottlieb states that “the FDA would prioritize enforcement of such products if they did not come off the market 30 days after the final guidance.” Non-grandfathered flavored cigars would then have to apply for premarket authorization in order to be re-introduced to the market. Under the new guidelines, producers of these new flavored cigars would have until August 2021 to file premarket applications.

“Additionally, we’re moving forward with a proposed rule to ban all characterizing flavors in cigars,” said Gottlieb. If finalized, this new rule may eventually remove all flavored cigars from shelves.

Since today’s announcement was only a draft guidance, the FDA is seeking public comments. “FDA requests comments and/or data on the number of currently marketed flavored cigars that were on the market as of February 15, 2007 (i.e. flavored cigars that are not considered “new tobacco products”). In addition, FDA requests comments, including data, research results, and other information, on how FDA should prioritize enforcement of actions with respect to flavored cigars (other than tobacco-flavored) that were on the market on August 8, 2016, and that meet the definition of a new tobacco product.”

The commenting period begins tomorrow. The FDA says that all comments must be submitted by April 15 to ensure that the agency will consider them while working on final guidance for flavored cigars.