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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
“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 […]
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 […]