On the first full day of business for the new decade, the U.S. Food and Drug Administration issued final guidance on how it plans to enforce regulations around deemed tobacco products that do not have the proper pre-market authorization. At the top of the list are flavored ENDS (Electronic Nicotine Delivery System) products. At the […]
Cigar News: PCA Recommends Immediate Compliance of Tobacco 21 Following FDA Announcement
William Cooper Cigar News No Comments FDA, News, PCA, Tobacco 21
Today the Premium Cigar Association (PCA) advised its retail members to will immediately stop selling to anyone under the age of 21 following an announcement by the U.S. Food and Drug Administration (FDA) regarding the Federal Government raising the tobacco purchase age to 21. The FDA issued the following statement on its website: The legislation […]
Cigar News: Micallef Cigars Establishes PredX – The Predicate Exchange
William Cooper Cigar News 1 Comment FDA, Micallef Cigars, News, PredX
Micallef Cigars has announce the launch of PredX – The Predicate Exchange. It’s a concept that involves pooling together predicate blends and intellectual property, and allowing members to submit, search, and license them to members. It’s intended to facilitate getting predicate (grandfathered) blends subject to the U.S. Food and Drug Administration (FDA) Deeming Rules. The […]
Cigar News: President Trump Signs Legislation Making Minimum Age to Purchase Tobacco Products to 21
William Cooper Cigar News No Comments FDA, News, Tobacco 21
U.S. President Donald Trump has signed into law a massive 1.4 trillion dollar spending bill that includes language that will raise the minimum age to purchase tobacco products in the United States to 21. This essentially ends the Tobacco 21 movement to raise the minimum wage and gives anti-tobacco a huge victory. The law […]
Cigar News: Dr. Stephen Hahn Confirmed as FDA Commissioner
William Cooper Cigar News No Comments FDA, News, People
Dr. Stephen Hahn, President Donald Trump’s nominee for Commissioner of the U.S. Food and Drug Administration (FDA) was confirmed by the United States Senate to be the next FDA Commissioner. “I congratulate Dr. Hahn and thank the Senate for prioritizing his nomination. President Trump has chosen a superbly qualified leader for FDA, and Dr. Hahn […]
Cigar News: Amendment Added to Exempt Premium Cigars Over $12.00 from Anti-Tobacco Bill
William Cooper Cigar News 1 Comment FDA, News
Today an amendment was added to HR 2339, a comprehensive anti-tobacco bill that last week passed a U.S. House of Representatives subcommittee. In the amendment to the bill is language that would exempt premium cigars from a ban on internet and catalog sales as well as exemption from the U.S. Food and Drug Administration’s costly […]
Cigar News: President Trump to Nominate Dr. Stephen Hahn for FDA Commissioner
William Cooper Cigar News No Comments FDA, News
United States President Donald Trump will nominate Dr. Stephen Hahn to be the next U.S. Food and Drug Administration (FDA) Commissioner. Dr. Hahn is an oncologist who currently serves as the Chief Medical Executive of the MD Anderson Cancer Center. In a related move, the Department of Health and Human Services (HHS), which the FDA […]
Cigar News: FDA To Appeal Maryland Court Ruling on Substantial Equivalence Date
William Cooper Cigar News No Comments FDA, News
The FDA is helping the cigar industry in the fight against the agency itself. Yes, it’s happening as today the U.S. Food and Drug Administration (FDA) has filed an appeal on the decision of Judge Paul Grimm of the United States District Court for the District of Maryland which moved to accelerate the timetable where […]
Cigar News: Judge Rules Against Cigar Industry in Delaying Substantial Equivalence Deadline
William Cooper Cigar News No Comments FDA, News
The cigar industry suffered another defeat in court when Judge Amit P Mehta of the U.S. District Court of the District of Columbia ruled against Motion for Partial Summary Judgment filed by the cigar industry trade associations (Cigar Association of America, Cigar Rights of America, and the International Premium Cigar and Pipe Retailers Association) to […]
Cigar News: Cigar Companies and Trade Organizations Issue Comments to FDA on Substantial Equivalence
William Cooper Cigar News 4 Comments CLE, CRA, Davidoff, Drew Estate, FDA, General, IPCPR, PCA, Perdomo, Tabacalera USA
Earlier this year, the U.S. Food and Drug Administration (FDA) published draft guidance on the Substantial Equivalence process. As a part of issuing such guidance, there must be a public comment period. The comment period came to a close on July 17th (following a 30-day extension granted by the FDA). This saw many cigar companies […]