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FDA

FDA Extends Deadline to File Ingredients

Some welcome news out of Washington. Today, FDA extended the deadline to file ingredients from 2/8/16 to 8/8/17. The Guidance, https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM527044.pdf, states in relevant part: The preamble to the deeming rule (81 FR 28974) stated that FDA does not intend to enforce the requirement to submit ingredient listing for manufacturers and importers of newly deemed tobacco products that were introduced into interstate commerce on or before August 8, 2016 provided submissions are received by February […]

December 28, 2016 by The Cigar Authority

FDA Answers Questions Regarding Substantial Equivlence

According to a press release from the FDA, any brand that had a quantity count change after 2007, constitutes a new product. Something that the cigar industry is sure to challenge. The FDA issues a new press release today that included a link to a FAQ answering some questions in regards to Substantial Equivlence. The press release states, “Today, the FDA is issuing the third edition of the guidance for industry titled Demonstrating the Substantial […]

December 12, 2016 by The Cigar Authority

FDA Issues Warning Letter To Parent Company of Drew Estate

According to a press release from the FDA, The U.S. Food and Drug Administration (FDA) has issued warning letters to four tobacco manufacturers—Swisher International Inc., Cheyenne International LLC, Prime Time International Co., and Southern Cross Tobacco Company Inc.—for selling flavored cigarettes that are labeled as little cigars or cigars, which is a violation of the Family Smoking Prevention and Tobacco Control Act (TCA). The companies received warning letters for products under the “Swisher Sweets,” “Cheyenne,” “Prime Time,” and […]

December 12, 2016 by The Cigar Authority

FDA Extends Deadline For Product Listing Until June 30, 2017

Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act. The guidance has been revised again to clarify that for U.S. manufacturers of newly […]

December 9, 2016 by The Cigar Authority

Appropriations Bill Sees FDA Exemption Stripped in Proposal by Congress

There was hope that the cigar industry would receive a Hail Mary when earlier this year, the House Appropriations Committee approved a bill that provided an exemption for premium cigars from the over-reach of the FDA. However, in a bill proposal last night that will fund the U.S. Government until the spring of 2017 the language that would have provided safe passage for premium cigars was stripped from the bill. The bill will fund the […]

December 7, 2016 by The Cigar Authority

Is President Elect Trump Good For Cigars – A David Garofalo Editorial

Is President Trump Going to be good for Cigar Smokers…. it looks that way! The Trump Administration Transition would be calling for a “temporary moratorium on all new regulations.” Stay tuned for possible good news. Here are just some of the reasons it looks that way… see if you agree. Vice President-Elect Mike Pence is a past co-sponsor of the Premium Cigar Exemption legislation, when he served in the U.S. House of Representatives. Georgia Congressman […]

November 30, 2016 by The Cigar Authority

FDA Withdraws Final Rule Regarding Procedures for Refusing to Accept Premarket Tobacco Products Submissions

According to the Cigar Rights of America, the FDA has withdrawn its Final Rule regarding the procedures for refusing to accept premarket tobacco products submissions. In a letter to its stakeholders the CRA states: In our continuing effort to keep you informed of actions and communications from or about the U.S. Food & Drug Administration – Center for Tobacco Products, please see the announcement below. Today, the FDA posted in their advanced Federal Register notice […]

November 15, 2016 by The Cigar Authority

EP Carrillo Names Jose Blanco Senior Vice President

The FDA has forced the hand of Jose Blanco. Citing the uncertainty of the FDA Ruling, Jose Blanco has accepted a role with the company owned by Ernesto Perez Carrillo. That role is Senior Vice President. According to Jose Blanco the brands under his company Las Cumbres which was formed in 2014 will be handled by his wife Emma Viktorsson. Blanco stated exclusively to The Cigar Authority, “Emma will manage it all – we have […]

October 27, 2016 by The Cigar Authority

Obama Hurting U.S. Small Business by Easing Restriction on Cuban Cigars – A David Garofalo Editorial

PLEASE… stop asking that question… The Cuban Embargo is NOT Over, but there has been yet another kick in the cojones for American businesses and the creation of an unfair playing field, if you ask me. Americans traveling abroad can now return with all the Cuban cigars and Cuban rum they want and they don’t go through any of the same pesky regulations and taxation that all other cigars have to go through. This “free […]

October 24, 2016 by The Cigar Authority

Rocky Patel Announces Price Increase Due To FDA

In a letter sent to retailers, Rocky Patel has announced a price increase due to the new FDA regulations. The letter which was sent late yesterday states, “Due to rising costs associated with the Food and Drug Administration we are announcing the following price increase on our brands. Effective November 15, 2016, we will be taking a 5% price increase on all Rocky Patel Branded Product with the exception of RP Decade (2.5%) and RP […]

October 14, 2016 by The Cigar Authority

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