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FDA

Cigar Industry Wins In Warning Label Case vs FDA

The cigar industry scored a win today against the FDA when Judge Amit P. Mehta ruled in their favor over warning label requirements. If the FDA was allowed to create labeling rules, the majority of cigar boxes would have covered with a a warning. In his conclusion Judge Mehta wrote, “The Deeming Rule’s warnings requirement for premium cigars is hereby vacated” before adding,  “this portion of the Rule is remanded to the agency for further […]

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The After Show Discusses FDA Guidance, Did We Get A Win?

Recently the FDA said that enforcing regulations on the cigar industry is a low priority. Some people say this was a win, but was it? Our own Mr. Jonathan did some research on the guidance issued by the FDA that shows this isn’t the win people think it is. Tune in as we discuss the FDA on The After Show sponsored by RoMaCraft Tobac. The Cigar Authority is a member of the United Podcast Network […]

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FDA Begins Enforcing Tobacco 21 – NATO Press Release

The National Association of Tobacco Outlets has sent an email to its members denoting the FDA has stated that they are enforcing the Federal Age 21 Purchase Law immediately. The press releases goes on to say… As reported this past week President Trump signed into law a federal government funding bill (U.S. House Bill 1865) that contains a provision raising the legal age to purchase any kind of tobacco product to 21 years of age. […]

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House Committee Passes HR 2339 But Was It Really A Win?

First, let me state this article is 100% the opinion of Barry. It is being typed from my fingers. Yesterday, HR 2339 passed the committee vote by a vote of 28-24 and some people are calling this a win for the cigar industry. It is, to a degree, because it appears cigars are getting an exemption. However, that exemption is only being offered to a select few brands as they appear on the shelf at […]

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FDA Files An Appeal To Delay Tobacco Deadlines

The United States Food and Drug Administration and the United States Department of Health and Human Services, through the U.S. Justice Department, filed an appeal the decision of Judge Paul Grimm to the United States Court of Appeals for the Fourth Circuit in the case of American Academy of Pediatrics, et al. v. United States Food and Drug Administration, et al. On May 15, 2019, Judge Grimm found, in an opinion focused almost exclusively on […]

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CRA Issues Statement As FDA Files Appeal to Postpone Substantial Equivalence

Cigar Rights of America is pleased to report that the FDA has appealed the decision of Judge Grimm of the United States District Court for the District of Maryland which dissolved the Guidance issued by the Food and Drug Administration delaying the filing date of Substantial Equivalence Reports for all newly deemed tobacco products, including Premium Cigars. The Government’s appeal of Judge Grimm’s ruling indicates that they believe that the FDA Guidance postponing enforcement of […]

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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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