FDA/Deeming Regulations

It’s only five questions, but nearly 3,000 words. Here’s what I think matters about today’s win in the “premium cigar” lawsuit.

And yet, the lawsuit isn’t over. The case heads back to the original court so that a judge can determine what a “premium cigar” is.

The Trump administration has signaled that, at least as of now, it is not interested in new FDA regulations on tobacco products. None of these moves are permanent.

The FDA has withdrawn the two proposals, meaning the agency does not intend to move forward with either ban at this time. That said, it could reverse course at any point.

On Jan. 16, 2025, the comment period for the FDA’s proposed rule regarding nicotine limits will open, the next step in a process that started nearly seven years ago. As of now, “premium cigars” are exempt from the proposal, though flavored cigars and pipe tobacco are included.

There are just 40 days until the Trump administration takes over, meaning this is more a PR stunt than an actual attempt at getting the rule to become law. It’s unclear whether would apply to only cigarettes though it likely applies to other tobacco products except “premium cigars,” at least for now. Yes, it’s both complicated and also likely irrelevant.

Trump has chosen Dr. Martin Makary, a surgeon, as his nominee to be the next commissioner of the FDA. Russell Vought has been selected to once again lead the Office of Management and Budget.

Despite being the nephew of noted cigar lover President John F. Kennedy, the cigar world probably doesn’t want Robert F. Kennedy Jr. “going wild” on tobacco regulation. His nomination is subject to Senate confirmation.

Susie Wiles, co-chair of Trump’s 2024 presidential campaign, has been selected as his chief of staff. Earlier this year, Swisher paid a lobbying firm $30,000 to have Wiles lobby Congress on “FDA regulations.”

If you were curious about the costs of FDA regulation on premium cigars, we now have an idea of one piece of the regulations. The government remains opposed to any refunds of user fees.

The eight-year-old lawsuit between three cigar trade groups and the FDA had its latest court room battle. In the hour-long hearing, the questions seemed to favor the cigar position that the FDA regulations should not apply to “premium cigars.”