Today U.S. President Donald Trump has announced that Alex Azar is his choice to replace Tom Price as Secretary of Health and Human Services (HHS) on his cabinet. Azar comes from the pharmaceutical industry where from 2012 to 2017, he served as President of Lilly USA, LLC, the largest affiliate of global biopharmaceutical leader Eli […]
The deadline for cigar manufacturers to submit ingredient listings has been extended yet again. This week, the U.S. Food and Drug Administration (FDA) announced the new deadlines would be May 8, 2018 for non-small-scale tobacco products manufacturers and November 8, 2018 for small-scale tobacco products manufacturers. This latest delay is due to technical issues encountered with […]
Editors Note: This was incorrectly reported by this author as ruling by the court. It was simply an acknowledgement of the court of the U.S. Food and Drug Administration’s (FDA) response to the cigar industry’s motion for injunction and summary judgement. A ruling is expected in the upcoming weeks. This error entirely lies on this author’s end […]
With natural disasters affecting the Caribbean and U.S., the U.S. Food and Drug Administration (FDA) announced it is extending the deadlines for submitting product ingredient listings and select health documents six months for manufacturers and importers located in the affected areas. The FDA stated: “The FDA is aware that tobacco manufacturers and importers in the […]
On Monday, October 16, 2017, a federal judge denied a motion for intervention by a group of health organizations to intervene in the cigar industry’s lawsuit filed against the U.S. Food and Drug Administration. The ruling was handed down by Judge Amit Mehta in the U.S. District Court for the District of Columbia. The Court […]
The U.S. Food and Drug Administration has issued its guidance on the regulations around free samples of tobacco products. In the guidance, the FDA confirmed that the free sample ban applies to all tobacco products, subject to its authority. The Deeming Rule which went into effect on August 8, 2016, extended this ban to cigars. The […]
For Special Edition #14, we look at the changes that are happening both domestically and internationally in the cigar industry – and why 2017 has been a pivotal year. Plus Cigar Dave made some interesting comments that pertain to cigar media, and we take a closer look at those comments and give our response. Additional Reference: Prime Time Special Edition […]
In what might be considered a major development in the cigar industry’s lawsuit against the U.S. Food and Drug Administration (FDA), the cigar trade associations have motioned the court for a preliminary injunction and partial summary judgment to prevent the FDA from moving forward with portions of the Deeming Regulations. The areas being targeted surround […]
The Tom Price era as Secretary of Health and Human Services (HHS) has come to an end. Today, Price offered his resignation to President Donald Trump, who subsequently accepted it. The resignation comes on the heels of an investigation into his use of private charter and military jets which resulted in costs of $1,000,000 to […]
In a move that was not unexpected, the U.S. Food and Drug Administration (FDA) will increase the user fees it is charging the U.S. tobacco industry. For Fiscal Year (FY) 2018, the industry will be charged $672 million dollars – an increase of $37 million dollars from FY 2017. From those numbers $64 million dollars […]
