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Cigar Industry, FDA Brief Court Over Potential Deregulation of Premium Cigars

Yesterday, the cigar industry and the Department of Justice submitted briefs regarding the outcome of a July 2022 ruling by a federal court in Washington, D.C. If the cigar industry is successful, “premium cigars” might be deregulated.

FDA Commissioner Orders Outside Review of Center for Tobacco Products & Others

The Reagan-Udall Foundation will evaluate FDA’s actions in regards to JUUL’s botched PMTA process as well as the baby formula shotrage.

Court Rules FDA Acted Improperly in Regulation of Premium Cigars

The premium cigar industry’s nearly six-year lawsuit against the U.S. Food & Drug Administration received its biggest win to date. The stage is set for premium cigars to be exempt from FDA regulation.

FDA’s Comment Period on Proposed Flavored Cigar Ban Ends Today (Update)

Manufacturers, retailers, consumers and other interested parties are invited to submit comments on the matter.

Cigar Groups Ask Federal Court to Throw Out FDA Regulations

Three cigar trade groups and the FDA walk into a Washington D.C. federal court room and the judge says… Seriously, there was a surprising number of jokes made during one of the most important hearings about the future of cigar regulation to date.

On the FDA

In April, the U.S. Food and Drug Administration (FDA) announced its intention to begin regulating a variety of tobacco products, including premium cigars. These proposed…

FDA Plans on Banning All Flavored Cigars, Menthol Cigarettes

Today, FDA announced proposed rules regarding flavored cigars and menthol cigarettes. In short, FDA will try to ban all flavored cigars from Swisher Sweets to ACID and Java. Lawsuits inbound.

Cigar Industry, FDA Lawsuit Hearing Delayed Until May 23

At the last minute, today’s scheduled oral arguments were delayed.

FDA FAQ

Did “big tobacco” support regulating premium cigars? Yes. Altria published this document supporting FDA’s regulation of all cigars, including premium cigars. Including premium cigars under the…

Dr. Robert Califf Confirmed as New FDA Head

Dr. Robert Califf is once again the commissioner of the U.S. Food & Drug Administration (FDA). By a vote of 50-46, Califf was confirmed by…

FDA: Apply to be the New Head of Center for Tobacco Products

The U.S. Food & Drug Administration has begun accepting applications for those interested in becoming the agency’s new director of FDA’s Center for Tobacco Products…

Announcing halfwheel.com/fda

Today, we launch our newest project, halfwheel.com/fda. It’s a microsite dedicated to breaking down the deeming regulations with more detail, but also with a much…

Califf’s Confirmation as New FDA Head Passes Key Hurdle

Dr. Robert Califf will likely be confirmed as the next commissioner of the U.S. Food & Drug Administration (FDA) by midday Tuesday. On Monday night,…

Swedish Match Suspends Plans to Sell Cigar Unit, Cites FDA

Swedish Match planned on spinning off its U.S. cigar business as early as this year, now those plans are on hold until after the company can work through issues regarding substantial equivalence applications denied by FDA.

Cigar Trade Groups, FDA Due Back in Court on May 4, 2022

Attorneys for the cigar industry and FDA will be back in court in early May to argue about whether or not the agency properly followed rules when choosing to regulate all cigars the same way. If the cigar industry is victorious, the ramifications could be as large as throwing out the FDA regulations for “premium cigars.”

Biden Nominates Robert Califf as Next FDA Commissioner

Confirming speculation that began to surface in mid-October, today President Joe Biden nominated Dr. Califf to be the new commissioner of the U.S. Food &…