Report: Biden Selecting Robert Califf as Next FDA Head
Dr. Robert Califf might once again lead the U.S. Food & Drug Administration. According to a report from The Washington Post, President Joe Biden plans…
FDA Publishes Finalized Substantial Equivalence Rule, Impact for Cigars Unclear
Today, the U.S. Food & Drug Administration (FDA) announced finalized rules for companies wishing to get FDA approval for tobacco products through the substantial equivalence…
FDA Tells Swisher Its Cigars Can Remain on Market Pending SE Reviews, Request Lawsuit Moves to D.C.
There have been a plethora of filings in the lawsuit filed by Swisher against the U.S. Food & Drug Administration (FDA) earlier this month, including…
Swisher Sues FDA Over Sept. 9 Premarket Approval Enforcement
On Sept. 9, 2021, tobacco companies—albeit very few premium cigar companies—could be required to remove their products from shelves while the companies wait for the…
Senate Agriculture Bill Would Direct FDA to Report on Premium Cigar Exemption
Yesterday, the U.S. Senate Committee on Appropriations approved S. 2599, the 2022 Agriculture Appropriations bill. In it, language is included that would direct the U.S….
Five Things: What Today’s Federal Appeals Court Loss Means for Cigars
Today, the cigar industry suffered a resounding defeat at the U.S. Court of Appeals for the District of Columbia. It’s the latest ruling in Cigar…
Federal Appeals Court Sharply Rejects Cigar Industry’s Appeal in FDA Lawsuit
The three cigar industry trade groups have lost their most recent appeal in the ongoing lawsuit over FDA’s deeming regulations. The decision was unanimous and…
Supreme Court Declines to Consider Vape Industry’s FDA Regulation Lawsuit
The vaping industry’s second attempt at getting the U.S. Supreme Court to hear arguments challenging the validity of FDA’s deeming regulations has hit a dead…
Bill Seeking Premium Cigar Exemption from FDA Regulations Introduced Again in House of Representatives
Last week, Rep. Kathy Castor, D-Fla., introduced H.R.3982, another bill aimed at exempting premium cigars from FDA regulations. It’s a companion bill to S.438—which was…
FDA Exploring Whether to Require Product Standards for Tobacco Manufacturing
The U.S. Food & Drug Administration (FDA) says that it plans on exploring whether it should require certain requirements for the manufacturing, packing, and storage…
FDA Says Premium Cigar Review Won’t Be Done Until Spring 2022, Withdraws ANRPM
It seems likely that cigar companies will have, at the very least, another year before the substantial equivalence process for “premium cigars” might resume according…
