Deeming Regulations

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…

Cigar Groups, FDA Meet Again in Federal Appeals Court

Earlier this morning, the two sides of a cigar industry lawsuit against the U.S. Food & Drug Administration (FDA) met once again, this time in…