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FDA

Senate Confirms Dr. Califf to Lead FDA

There are many in the cigar industry that felt the FDA regulations on cigars would not be announced until a new leader of the FDA was named. According to a report on Reuters, the United States Senate is close to confirming the next leader of the Food & Drug Administration despite an opposition from several senators and a Presidential candidate. On Monday the Senate voted 80-6 in favor of limiting debate on the matter to […]

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Action Needed Now To Save Cigars!

Now is the Time to Contact Speaker of the House Paul Ryan & Senate Majority Leader Mitch McConnell Since the Tobacco Control Act took effect, cigar patrons, retail tobacconists and manufacturers from across the premium cigar industry have been fighting in Washington, D.C. to preserve the simple enjoyment of a premium cigar – to protect that enjoyment from a threatening bureaucracy at the U.S. Food & Drug Administration. At this very moment, Congress is debating the federal […]

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FDA Issues First Product Marketing Orders

The following press release was released today by the FDA; and while the article pertains to Snus it is interesting to note how this could become part of the norm for cigars pending the OMB review of the FDA guidelines submitted. FDA issues first product marketing orders through premarket tobacco application pathway Following a rigorous, science-based review, the U.S. Food and Drug Administration announced today that for the first time it has authorized the marketing […]

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Document Containing FDA Option 1 Leaked, Is It Valid? *UPDATE*

Last night the Tobacco Vapor Electronic Cigarette Association shared a message stating they had obtained a copy of the FDA Deeming Regulations as proposed to the OMB. Since that message from TVECA there have been conflicting reports to the validity of the document. The document which proposes Option 1 would be the worst possible news for the cigar industry and would put all brands that have come in to the marketplace after 2007 in jeopardy. This is […]

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Podcast: Digging Deep Into David’s Humidor

This week we dig deep into David’s humidor and smoke a couple of cigars that have a collective 34 years worth of age on them. Barry picked one, and Dave picked the other. You will be surprised what they chose that will serve as a testament to how much the cigar industry has changed. We will also define what it means now that the FDA Deeming Regulations are in the hands of the OMB; address […]

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The OMB Has The FDA Regulations In Hand, What Does It Mean?

Last night I must of fielded about 2 dozen text messages and at least that many private messages on Facebook asking what the FDA regulations are and what is the OMB. I’ll be honest with you a lot of the process is something I had to research and teach myself last night but here goes… We have known that the FDA was looking to regulate cigars, pipe tobacco, e-cigarettes, hookah and more since April of […]

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Cigar Rights of America Emails Supporters On Today’s FDA News

In addition to the following email sent to the supporters of the CRA; The Cigar Rights of America has also shared how they plan to go about the potential regulations. We have omitted that from this posting. From the CRA: Today, The White House Office of Management & Budget (OMB) – Office of Information & Regulatory Affairs published that they have received a Draft Final Rule for deeming cigars subject to federal regulation. As you […]

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FDA Deeming Regulations Now In Hands Of OMB *Updated*

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 […]

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FDA Deeming Rules On Cigars Could Come Next Week

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 […]

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President Obama Nominates Dr. Robert Califf for FDA Commissioner

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 […]

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