News: FDA Commissioner’s Resignation Could Have Big Implications for Cigar Regulations

Late yesterday reports broke that U.S. Food & Drug Administration (FDA) Commissioner Scott Gottlieb would be resigning his position next month. The move comes less than two years after Gottlieb was confirmed to the position in May 2017.

According to a Washington Post report, Gottlieb’s resignation didn’t come at the request of the the White House. President Trump tweeted praise of Gottlieb’s job at the FDA. “Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things.”

Gottlieb, who had been commuting from Connecticut weekly, told the Post it was a difficult decision. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends, and come back to Washington on Sunday.”

Gottlieb’s confirmation was supported by cigar industry groups based on his prior writings questioning the logic of FDA tobacco cigar regulations. But his time at the FDA was a mixed bag for cigars. Gottlieb came into the job known for a “harm reduction” approach to tobacco regulations.

One of Gottlieb’s first acts was to delay upcoming deadlines for implementing the FDA’s Deeming Rule, which included new cigars. He later initiated another round of rule-making on whether the FDA should adopt an exemption for premium cigars. Later, Gottlieb pushed for a ban on flavored tobacco products.

Next Commissioner Faces Big Decisions on Cigar Regulations

Gottlieb’s departure leaves the next head of the FDA to make major decisions regarding the FDA’s oversight of premium cigars. A permanent replacement for Gottlieb would need to go through a Senate confirmation process, which would take months given the backlog of other nominees awaiting confirmation votes. An acting commissioner could be named more quickly, but no decisions have been made about who would fill the post.

The FDA could issue a final rule on the premium cigar exemption any day now and, unless it comes in the next month, it may be one of the first big decisions made by the next commissioner. If a final rule isn’t issued before late spring 2020, the rule can be overturned using the Congressional Review Act by a new Congress and president after the 2020 elections.

The next commissioner would also be primed to make final rulings on flavored tobacco products and on an FDA initiative for reduced nicotine tobacco products. Cigar industry groups would do well to lobby the White House for a nominee who is likely to issue premium cigars a long sought-after exemption from FDA rules.

–Patrick S

photo credits: Stogie Guys