This morning sources to The Cigar Authority informed us that the White House Office of Management and Budget has received a copy of the final FDA Deeming Regulations. The document which was rumored to be in their hands for more than a week has been officially acknowledged. While the information contained within the document has not yet been made public as changes could be made by the OMB, The Cigar Authority will work to bring […]
News is traveling among industry insiders that the U.S. Food & Drug Administration (FDA) intends to deliver the final Deeming Rules to the White House Office of Management & Budget next week. The news comes from the Washington “rumor mill” which is abuzz with the topic today. As a result some manufacturers have mentioned this via social media accounts and the CRA has emailed its corporate benefactors to alert them including the outline of their […]
According to Reuters, President Barack Obama has nominated a leading cardiologist and researcher for the position of FDA Commissioner. Dr. Robert Califf joined the FDA in January as Deputy Commissioner. Before the position becomes official Dr. Califf will go before the Senate for a confirmation hearing and industry observers do not expect him to face much opposition. If confirmed by the Senate Dr. Califf would replace Dr. Stephen Ostroff, who has served as acting commissioner […]
The following statement was sent by IPCPR this afternoon, Today, the U.S. House Appropriations Committee considered the FY 2016 Agriculture Appropriations Bill which passed 29-21. The legislation will now be schedule for consideration on the House Floor. Included in this bill was a provision to make a technical change to the Tobacco Control Act, affecting the regulation of premium cigars, pipe tobacco, and other tobacco products. When the Tobacco Control Act was passed into law, […]
According to a report at CQ Roll Call, the House Appropriations Committee’s fiscal 2016 Agriculture spending bill includes a provision that would limit the FDA’s ability to regulate products. The provision is in Section 747, and would change the date introduced in a 2009 law that said commercial tobacco products introduced after February 15th, 2007 would be subject to pre-market review. The provision would change that date by defining new tobacco products as those that enter […]
The FDA strikes again, and this time it has to do with the marketing of tobacco products. According to a report published on the FDA website, advertising or marketing a tobacco product that was released after February 15, 2007 could become a thing of the past. A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product; or has different characteristics than the predicate tobacco product […]
The following is a message from IPCPR that was shared with The Cigar Authority from our sources. FDA Announces Interim Enforcement Policy Related to Substantial Equivalence FAQ Guidance While FDA considers new comments to the recently issued Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions guidance, the agency is announcing its interim enforcement policy. This interim policy is effective immediately and will continue until 30 days after FDA issues […]
An interesting article posted over at the Convenience Store News website shows the FDA this week issued a guidance document titled, “Determination of the Period Covered by a No Tobacco Sales Order and Compliance with an Order.” The article which states under the Family Smoking Prevention and Tobacco Control Act, the FDA was authorized to conduct retail compliance inspections and impose fines for violations that would culminate in a “no-tobacco-sales” order for repeat violations. The order would […]
Since the TAA Convention last month we have heard rumblings that the FDA was close to making a ruling on the deeming regulations that the cigar industry faces. Currently, the FDA has a date of February 15, 2007 for these regulations which would put many companies out of business. In short, cigars that came to the market before then would be given a free pass, while those after the date would have to apply to have […]
THE COUNDOWN HAS BEGUN… 28 days… 27 days… 26 days… 25 days Our Days Numbered for the Cigar Industry as we know it? The Cigar Authority has learned that the FDA has finalized their review of comments on Cigars and has made revisions to the proposed rule. The Deeming Regulations of Cigars has now been sent to the Department of Health and Human Services for further review before it is sent to White House […]