Tag Archives: fda

IPCPR & CRA Joint Statement on ANPRM Comment

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Yesterday, IPCPR and Cigar Rights of America filed a joint comment in response to the U.S. Food and Drug Administration’s ongoing review of how it should define and treat premium cigars. This process, known as an Advanced Notice of Proposed Rulemaking – marked a major milestone for premium cigar retailers, manufacturers, consumers and the industry at large. It was an opportunity for IPCPR, CRA and other stakeholders in the industry to provide another evidentiary based justification for why premium cigars should be regulated differently from the direction the agency has thus far taken.

Through the comment, both IPCPR and CRA laid out a host of recently published data, collected and analyzed by federal agencies and scientists at the FDA. Through the analysis of the government sponsored data, the premium cigar industry found that:

  • Premium cigars are luxury items purchased and smoked infrequently by adults;
  • The average premium cigar consumer smokes as little as 1.1 days per month;
  • Youth engagement with premium cigar products is so minimal it was determined to be statistically insignificant;
  • Premium cigars are not used by consumers as an alternative or supplemental source of nicotine.

This data, published since cigar regulations went into effect in August 2016, counters the FDA’s justification for applying burdensome new requirements on the industry.

Scott Pearce, IPCPR Executive Director, recognizes these comments are a definitive step in the continued fight for recognition by the Federal Government. “These comments represent everything that is great about both IPCPR and the premium cigar industry.  They underscore the craft of premium cigars, the importance of the brick and mortar storefronts to local economies across the country, and the makeup of consumers who enjoy the products.  If heeded, these will help ensure a free and fair environment for our retailers to flourish in and continue the great cigar (and pipe tobacco) culture.”

CRA Executive Director Glynn Loope stated, “The Final Rule as issued by the previous administration was a solution in search of a problem. The studies and comments filed by the premium cigar industry last night provide substantive answers to the FDA solicitation for comment, with analysis and recommendations for relief from rules that 289 current and former members of the U.S. House of Representatives, twenty-six current and former members of the U.S. Senate have stated are burdensome, unfair, and go beyond congressional intent. Now, we can add a federal judge that has noted how unjustly the industry has been treated. Now is the time to correct this case study in bureaucratic overreach.”

With the comment period now closed, it is now up to the FDA and the Trump Administration to take the unassailable science and proposed definition provided by the industry and make the right decision. Change the structure of the Deeming Rule, define and exempt premium cigars and finally bring economic relief and a sense of certainty and security to thousands of small businesses and tens of thousands of Americans across the country.

Ken P. Neumann, President of the IPCPR Board of Directors, is hopeful. “One thing we have seen with this administration time and time again is a willingness to look at the regulatory status quo it inherited and say, “I don’t think so.””

While there is no required timeline or next steps for the FDA or the Trump Administration, IPCPR, CRA and the rest of the industry will continue to engage on Capitol Hill and in the Executive Branch, and advocate for a timely and just resolution.

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FDA Warning Label Lawsuit Update from IPCPR

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Federal Judge Delays Cigar Warning Requirements

Earlier today, D.C. District Court Judge Amit Mehta issued an injunction prohibiting the U.S. Food & Drug Administration from enforcing its warning label requirements on cigars and pipe tobacco. The warning label requirements for packaging and advertising were slated to go into effect on August 10th. Judge Mehta’s order delays any enforcement of the requirement until at least 60 days after the conclusion of an appeal currently underway.  No date has been set for a court to hear the appeal.

Today’s decision is a direct result of the ongoing lawsuit brought by IPCPR, the Cigar Association of America and the Cigar Rights of America. Judge Mehta had previously ruled on this case in May – and did not endorse the Associations’ challenge to the warning labels issue. Following the ruling, IPCPR, CAA and CRA appealed and requested that Judge Mehta prohibit the FDA’s warning label requirements until a decision on the appeal is finalized.  In his order issued today, Judge Mehta agreed, recognizing the suit raises substantial and complex issues about retailers’ constitutional rights, and that the FDA was not justified to require warnings before those issues are fully resolved, “In the end, this court believes that Plaintiffs are entitled to a full hearing before an appellate court with the specter of a warnings regime going into effect.”

Scott Pearce, IPCPR Executive Director recognizes this is a positive, if not temporary development for retailers and the broader industry.  “This deadline has been bearing down on our members for some time now.  And while this is a temporary reprieve, it is a welcome development and hopefully a sign that our message is resonating. IPCPR is proud to be a party to this lawsuit, and we’ll continue to work with our great legal team and staff in DC to bring about the optimum regulatory framework for the premium cigar industry.”

For questions on today’s injunction or any issues concerning the FDA’s Deeming Rule – please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at daniel@ipcpr.org.

FDA Announces Extension to Tobacco Related ANPRMs

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Earlier today, the US Food & Drug Administration (FDA) announced extensions to three advanced notice of proposed rulemaking (ANPRM) dockets currently underway.  The extension covers the ANPRMs on nicotine reduction, flavors and premium cigars.

This extension provides additional time for industry to present its case to the administration and submit comments to the FDA.  IPCPR, along with other industry associations, members of Congress and industry stakeholders submitted extension requests. Our association applauds the FDA’s decision and attributes it to the continued dialogue IPCPR has forged on Capitol Hill and with the FDA regarding premium cigars and a need to exempt this niche artisanal industry from an ill-suited regulatory framework.

The new ANPRM deadlines are listed below:

For any questions concerning the ANPRM, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at daniel@ipcpr.org.