Browsing Tag

FDA

Agreement Reached on Suspension of Regulations Cigar & Pipe Advocacy Groups Announce Rule Deferment Pending Further Review

The following press release comes from Cigar Rights of America announcing an extension of upcoming compliance. WASHINGTON, D.C. – Since July 15, 2016, Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers Association (IPCPR) have been pursuing litigation in federal court against the United States Food and Drug Administration (FDA), challenging the FDA’s May 10, 2016 Rule deeming cigars and pipe tobacco to be tobacco products subject […]

Continue Reading

States File In Support Of Opposition Of FDA Regulations Against Cigars

A rebellion. A group of freedom fights have signed up in support of the cigar industry against the tyrannical reign of the FDA. This group is in the form of states Arizona, Louisiana, Michigan and Texas for filed a 27 page brief opposing the FDA regulations of cigars. The brief which was filed on February 21 is part of the lawsuit which will be heard on July 28th, 2017 that puts plaintiffs Cigar Association of America, Cigar […]

Continue Reading

Cigar Industry’s Lawsuit Against FDA Deeming Rule Moves Forward

WASHINGTON, D.C. – Yesterday, in the U.S. District Court for the District of Columbia, the Cigar Association of America, the International Premium Cigar & Pipe Retailers Association and Cigar Rights of America filed a Motion for Summary Judgment and opening brief in the cigar industry’s litigation challenging the FDA’s Final Deeming Rule. This filing serves as the next phase in the premium cigar industry’s joint litigation challenging FDA’s Final Deeming Rule, which began earlier this year in July […]

Continue Reading

FDA Creates New Database For Grandfathered Tobacco Products

The FDA refers to a tobacco product that was commercially marketed (other than exclusively in test markets) in the U.S. as of Feb. 15, 2007, as a “grandfathered” tobacco product. These grandfathered products are not subject to the premarket requirements of the Federal Food, Drug, and Cosmetic Act and may serve as the predicate tobacco product in an application demonstrating substantial equivalence (SE) for a new tobacco product. The FDA’s new database contains determination information […]

Continue Reading

Bill Introduced in US Senate To Exempt Premium Cigars From FDA

Yesterday, United States Senator Bill Nelson (D-FL) re-introduced legislation to exempt premium cigars from FDA regulation. The bill, Senate Bill 294 (“S. 294”), was introduced with a total of 10 original sponsors and co-sponsors, which include Senator Marco Rubio (R-FL), Senator Joe Manchin (D-WV), Senator Daines (R-MT), Senator Tester (D-MT), Senator John Boozman (R-AR), Senator Mazie Hirono (D-HI), Senator Corey Gardner (R-CO), Senator Robert Casey (D-PA) and Senator Dean Heller (R-NV). Like S. 441 and […]

Continue Reading

White House Freezes All Pending Regulations

This afternoon, shortly after the inauguration of President Trump the White House ordered a freeze of all pending regulations.   The move was made so all regulations including the FDA regulations on cigars can be reviewed by the Trump administration.  The memo came from White House Chief of Staff, Reince Priebus.  The move however is not new in the transfer of power, as the Obama administration enacted a regulatory freeze in 2009 after taking office […]

Continue Reading

JC Newman Announces Price Increase

JC Newman is another company that has been forced to raise prices due to the FDA. According to an email received from the company, “Due to the cost of compliance with the new FDA regulations, as well as rising manufacturing costs, prices have been adjusted slightly effective January 16, 2017.” According to our math it seems that Diamond Crown Cigars are going up 2% while the popular Brick House brand will be going up between […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading

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 […]

Continue Reading