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FDA

VODCast: Cigar Industry Prediction Show

It’s one of the most popular shows every year and we expect this year to be no different. It’s the Cigar Industry Prediction show. We see so many reps, sales managers and brand owners over the course of the year and we hear more then our fair share of rumors. Some of them can quickly be written off, but some of them might just hold some truth to them. This year we make our prediction […]

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CRA Submits Docket Comment To FDA On Substantial Equivalence

As the comment period came to a close, on behalf of a coalition that includes 108 premium cigar companies, Cigar Rights of America (CRA) filed public comments, making the case that a one-size-fits-all approach to regulation of premium cigars, does not work. The sixty-one page document with almost a dozen attachments makes the case that premium cigars should be exempt from federal regulation, given the clear evidence from credible third-party studies that premium cigars do […]

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Six Cigar Companies Present Joint Statement to Challenge FDA Regulation on Substantial Equivalence

The largest manufacturers in the premium cigar industry today filed a 273 page joint comment with the Food & Drug Administration (“FDA”) opposing the agency’s Proposed Substantial Equivalence (“SE”) Rule, which would require manufacturers to submit to an extensive application and testing regime to keep any “non-grandfathered” cigars on the market. In this joint comment, premium cigar manufacturers Davidoff of Geneva USA, Drew Estate, General Cigar Company, Tabacalera USA, Perdomo Cigars, and C.L.E. Cigar Company […]

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Outgoing FDA Commissioner Scott Gottlieb Issues Statement on Tobacco

The following statement from Dr. Scott Gottlieb was issued today via an FDA Press Release which deals with substantial equivalence among other things. Our comprehensive plan on tobacco and nicotine regulation, unveiled in July 2017, aims to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could […]

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FDA Issues Draft Revised Compliance Policy for ENDS Products and Flavored Cigars – IPCPR Statement

IPCPR this morning issued an email about the recent FDA revised compliance that mostly affects Electonic Nicotine Delivery Systems (ENDS), however there is also a section of the policy that applies to flavored cigars. Below is the statement from IPCPR This morning, FDA announced draft guidance on “Modifications to Compliance Policy for Certain Deemed Tobacco Products”. Any changes in the compliance policy addressed in this Draft Guidance will not be implemented until 30 days after […]

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JC Newman Issues Statement on the Extended Deadline for HPHC Testing

“Today’s announcement is a huge relief for the premium cigar industry. Because there are no standards for testing premium cigars, there was no way that our four generation, 124-year-old family business could meet FDA’s rapidly approaching November testing deadline. FDA’s decision to extend the HPHC testing deadline until after the agency first issues guidance is eminently reasonable. “Although we will await FDA’s guidance, I remain very skeptical about whether it is possible to reliably test […]

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FDA Delays Testing Deadine

The FDA today delayed a Nov. 8, 2019 deadline for reporting the results of testing for harmful and potentially harmful constituents in every cigar and pipe tobacco product sold in the United States. This was a huge problem because the technology for testing premium cigars does not exist, and the FDA had provided no guidance on how it was supposed to be accomplished for cigars and pipe tobacco. The new deadline is now six months […]

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Dr. Gottlieb Resigns As Head of FDA

The commissioner of the FDA, Scott Gottlieb, announced Tuesday that he is resigning the position he has held or two years effective in one month. He has not yet given a reason for his departure but in a statement via Twitter he said, “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar […]

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Fox News Discusses Senator Rubio Cigar Exemption at JC Newman

Yesterday, Senator Marco Rubio (R-FL) reintroduced legislation in the United States Senate that would exempt premium cigars from FDA regulation. Joining Senator Rubio in co-sponsoring this bipartisan bill were Senators Corey Gardner (R-CO), Joe Manchin (D-WV), Tom Cotton (R-AR), Robert Menendez (D-NJ), and Joni Ernst (R-IA). This legislation was just the ninth bill filed in the Senate in the new 116th Congress. This morning, Fox 13 News visited J.C. Newman Cigar Company’s historic cigar factory […]

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New Study Documents Economic Harm of Premium Cigar Regulation

The following is a press release submitted by the Cigar Rights of America. A new report by Mangum Economics updates the out-of-date economic analysis of the Food and Drug Administration’s (“FDA”) regulation of premium handmade cigars, and estimates the number of U.S. jobs that will be lost because of the regulations. The report uses FDA’s own assumptions about the effects of the regulations and updates the calculations to use more recent government data. It also […]

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