President Joe Biden has announced he has nominated Dr. Robert Califf to return as U.S. Food and Drug Administration (FDA) Commissioner. Califf served as Deputy Commissioner of the FDA’s Office of Medical Products and Tobacco from January 2015 through February 2016. He was nominated by President Barack Obama and confirmed by the U.S. Senate to […]
After some delay, the House of Representatives now has a companion bill to the Senate Bill released earlier this year to exempt premium cigars from regulation from the U.S. Food and Drug Administration (FDA). The bill was introduced by Representatives Kathy Castor and Bill Posey. H.R. 3982 joins Senate Bill S.438 introduced by Senator Marco Rubio […]
On June 11, 2021, the Office of Information and Regulatory Affairs published the federal government’s Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions. As part of the Spring 2021 agenda, the U.S. Food and Drug Administration (FDA) has withdrawn an entry related to premium cigars. The decision is good news for the premium cigar […]
Cigar Rights of America (CRA) has issued the first statement on the U.S. Food and Drug Administration (FDA)’s proposed ban on flavored cigars. CRA issued the following statement: It is unclear at this time if the intended ban will apply only to mass-market flavored cigars. FDA intends to address this issue in the preamble to […]
Today the U.S. Food and Drug Administration (FDA) announced it is moving forward with a plan to ban menthol cigarettes and all characterizing flavors in cigars. The agency is working on codifying the new regulations and the next step will be to publish the proposed rules in the Federal Register, allowing an opportunity for public comment. […]
Xavier Becerra, the man whom President Joe Biden nominated for Secretary of Health and Human Services, was confirmed on March 18th for the position in a vote by the United States Senate by a vote of 50 to 49. 49 Democrats voted to confirm Becerra. One Republican, Senator Susan Collins (D, ME) also voted in […]
With the 117th Congress now in session, the time has come to reintroduce proposed legislation. This past week, Senate Bill S.438 was reintroduced by Senator Marco Rubio of Florida. The purpose of the bill is to introduce legislation to exempt premium cigars from regulations being proposed by the United States Food and Drug Administration (FDA). […]
The three trade associations (Cigar Association of America, Cigar Rights of America, and Premium Cigar Association) have filed a motion for summary judgment and permanent injunction with the U.S. District Court for the District of Columbia asking the Court to nullify the U.S. Food and Drug Administration’s Final Deeming Rule. The Deeming Rule is defines […]
On the last night of the Trump Administration being in office (January 19, 2021), the U.S. Food and Drug Administration (FDA) and Center for Tobacco Products (CTP) released rules about Substantial Equivalence (SE) and Premarket Tobacco Product Application (PMTA). Regarding premium cigars, the FDA did not apply the rules at this time. This is the […]
Yesterday’s decision by Judge Amit P Mehta delaying the implementation by the U.S Food and Drug Administration (FDA) of premarket authorization and substantial equivalence indefinitely, gave the premium cigar industry a much-needed win. Let’s face it – the premium cigar industry has taken a lot of lumps over the past decade. When it comes to […]
