Browsing Tag

Regulations

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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IPCPR Issues Statement On Yesterday’s FDA Ruling

Yesterday, Judge Amit Mehta issued an opinion on several issues raised in the IPCPR’s lawsuit against the FDA. Notably, Judge Mehta struck down the requirement that retailers who blend pipe tobacco must register their establishments with and submit product listings to the FDA. This is a positive development for IPCPR members and significantly eases the compliance burden facing many premium tobacconists around the country. However, Judge Mehta did not endorse other challenges to the FDA’s: […]

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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 […]

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FDA Launches Compliance Webinars

The Center for Tobacco Products is offering a series of webinars to help industry understand a recently finalized rule extending the FDA’s authority to all tobacco products. Under the rule, which is often referred to as the “deeming rule,” the FDA’s authority covers products such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among others. Some of the webinars are designed for specific audiences—tobacco retailers, vape shops, or manufacturers and importers, for example—to help them […]

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IPCPR Releases Initial Statement On FDA Regulations

While a joint press release between Cigar Rights of America and IPCPR later today, the official Facebook page of the IPCPR offered an initial statement on the regulations released by the FDA this morning… The statement reads as follows, “This morning, the Food and Drug Administration released its final determination deeming additional tobacco products, including premium cigars, subject to its authority under the Tobacco Control Act. IPCPR’s policy team is reviewing this complex determination (499 […]

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FDA Regulations – The Text

The following was filed this morning at 8:45am and is expected to be published on May 10th, The result would be that these regulations would go into effect 90 days from the publishing date, unless an act of Congress provides an exemption.

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FDA Regulations Announced, Press Conference At 10:30am

According to published reports Department of Health and Human Services Secretary Sylvia Burwell and FDA Administrator Robert Califf, a physician, are scheduled to brief reporters at 10:30 a.m. Thursday. HHS officials would not comment on the topic of the briefing. Currently there is a bill working its way through the House that would save premium cigars and change the predicate date from 2007 to the date FDA Regulations are announced (today). The FDA has chosen Option 1 which will […]

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FDA Seeks To Purchase Cigar Smoking Machines

As the cigar industry waits for the FDA ruling on cigars, some new information has come out about some of the things that the FDA will be looking at when it comes to regulation. On February 22, 2016, the FDA announced that they were seeking to purchase a Cigar Smoking Machine with CO Analyzer. According to the document, they are seeking a smoking machine capable of smoking a 22.5mm cigar which would be between a 57 and […]

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Senate Confirms Dr. Califf to Lead FDA

There are many in the cigar industry that felt the FDA regulations on cigars would not be announced until a new leader of the FDA was named. According to a report on Reuters, the United States Senate is close to confirming the next leader of the Food & Drug Administration despite an opposition from several senators and a Presidential candidate. On Monday the Senate voted 80-6 in favor of limiting debate on the matter to […]

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Cigar Rights of America Emails Supporters On Today’s FDA News

In addition to the following email sent to the supporters of the CRA; The Cigar Rights of America has also shared how they plan to go about the potential regulations. We have omitted that from this posting. From the CRA: Today, The White House Office of Management & Budget (OMB) – Office of Information & Regulatory Affairs published that they have received a Draft Final Rule for deeming cigars subject to federal regulation. As you […]

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