Category Archives: Update
IPCPR & CRA Joint Statement on ANPRM Comment
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.
IPCPR Emergency Notice
The IPCPR trade show will open today at 1:00 PM due to an electrical fire that occurred early this morning. Staff and crew are working hard to get everything ready and to ensure everyone’s safety.
The following companies have been effected, and as of right now only key personnel from the following companies are allowed on the show floor at this time:
AJ Fernandez
Al Capone
Arango
Bags of Bags
Drew Estate
Costello Pipe
Benchmade
Nat Sherman
Rocky Patel
La Palina
Cigar Oasis
Tommy Bahama
Rabbit Air
Perdomo
Security staff will be on site to escort representatives of these companies into the show floor at this time.
PLEASE NOTE: If you are attending any state association meetings, those will continue at their regularly scheduled hours. Shuttle buses will continue to run during these hours.
We apologize for the interruption to your show schedule and appreciate your patience and understanding as we deal with these issues.
Thank you –
IPCPR
FDA Warning Label Lawsuit Update from IPCPR
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.
IPCPR: Senators Send Letter to FDA on Premium Cigar Exemption
Earlier this week, Senators Marco Rubio and Bill Nelson led a bipartisan letter to FDA Commissioner Scott Gottlieb, directing the FDA to bring quick regulatory relief to the premium cigar industry. Signed by 17 Senators, the letter outlines the need for the quick adoption of a premium cigar definition by the agency and the ultimate exemption of that product category from current FDA regulations.
The letter comes as the FDA has recently extended by 30 days the public comment period for their review of current premium cigar regulations. The process, known as an Advanced Notice of Proposed Rulemaking (ANPRM), runs through July 25th.
Importantly, the letter’s signatories underlined their support for smart and impactful requirements that actually benefit the public health – particularly when it comes to youth. These are goals shared and actively supported by IPCPR’s retailers across the country. They correctly point out, however, that data resulting from government financed and executed public health surveys demonstrably show there is no correlation between premium cigars and youth use.
Each signatory to the letter is currently a co-sponsor of S. 294, legislation that seeks to define premium cigars and exempt them from the current regulatory regime. The letter reflects this underlying support and understanding of the existential threat facing thousands of small businesses around the country – “We have consistently heard from those impacted that the FDA’s regulation of premium cigars fails to recognize that these cigars are a unique product with a unique consumer base.” It goes on to request “that the FDA exempt premium cigars from the FDA’s regulations under the FSPTCA and use the definition of a traditional cigar provided in the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017, bipartisan legislation that we support”.
The IPCPR strongly applauds the letter. On behalf of our member retailers, their suppliers and the millions of Americans who enjoy premium cigars, IPCPR thanks Senators Rubio and Nelson and the 15 Members of the Senate who continue to vocalize this issue and fight for what’s right. We are encouraged by their continued recognition that premium cigars are an artisanal product supported by a small-business-driven industry and their advocacy for those small businesses to Commissioner Gottlieb. As the ANPRM process remains underway, IPCPR will continue to work with Congress and advocate on behalf of premium cigars.
For questions concerning the letter or any issues regarding FDA regulations, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at daniel@ipcpr.org.
FDA Warning Label Requirements for Cigar Packaging
August 10th marks a major milestone in the implementation of FDA’s Deeming Rule. On this date, the warning label requirements for cigar and pipe tobacco packaging and advertising go into effect. Below are a few things retailers should know ahead of time. IPCPR plans to release additional briefs on aspects of the warning label requirements over the coming days. These briefs will cover issues including the point-of-sale signage requirements for retailers of individual, unpackaged cigars and retailer obligations for advertising warning statements.
What are the Warning Label requirements for packaging?
Beginning on 8/10/2018, manufacturers of cigars must label product packages with six separate FDA warning statements. On the same date, manufacturers of pipe tobacco must label product packages with a nicotine-addictiveness warning. The labels must make up 30% of the two principal display panels of the package, comply with other formatting requirements, and in the case of cigars be displayed consistent with an FDA-approved warning plan.
Manufacturers have until the end of 9/10/2018 to introduce into domestic commerce any inventory of products in packaging that DOES NOT comply with the new FDA labeling requirements, AS LONG AS they were manufactured prior to 8/10/2018. (In the case of a domestically manufactured product, this could mean removal from the factory before 9/11/2018. In the case of an imported product, this could mean release of the product from customs before 9/11/2018.)
What does this mean for retailers?
On and after 8/10/2018, U.S. distributors and retailers may continue to sell, distribute or import products that do not have compliant warning labels, AS LONG AS the products were manufactured before 8/10/2018.
What happens if the FDA comes to my store? Will the Agency hold me responsible for any package labeling issue?
The labeling responsibility for packaging rests with manufacturers. And there are a series of protections under the Deeming Rule that reinforce this for retailers.
On and after 8/10/2018, retailers WILL NOT BE in violation for selling any packaged cigar or pipe tobacco product without compliant FDA warning labels AS LONG AS:
- The retailer can demonstrate or reasonably assert that the product at issue was manufactured prior to 8/10/2018 (and therefore is not subject to the warning requirements); or
- The package has some type of “health warning*”;
- The retailer obtained the product from an appropriately licensed manufacturer, importer, or distributor; and
- The retailer has not altered the product in a way that is material to the new requirements.
*It’s important to note that the regulations do not define what qualifies as a “health warning” for these purposes, but legacy FTC cigar health warnings, California health warnings, or improperly executed FDA warnings could qualify.
How do I “demonstrate or reasonably assert” a product’s manufacture date?
Ultimately, each individual supplier (including manufacturers, importers, and distributors) must determine how best to help assure its retailer customers that they may sell supplied products without FDA-compliant warning labels on or after 8/10/2018. Examples include:
- Provide a letter confirming the date on which the manufacturer began complying with the new warning label requirements;
- Include documentation confirming the date of manufacture (or the pre-8/10/2018 status) of products in a shipment;
- Include production date information on or in packaging; or
- Make such information available upon request and presentation of a labeled code.
In addition, IPCPR recommends that, as appropriate, retailers rely on their own records and inventory management practices for these purposes. For example, this could include:
- Completing a physical inventory of packaged products on hand before 8/10/2018 (and thereafter as appropriate); and either
- Applying a sticker or other marking to help the retailer identify the date of inventory of each package; or
- Segregating products manufactured before 8/10/2018 to allow the retailer to identify products not subject to the warning requirements.
For any additional questions or concerns regarding warning labeling requirements, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at Daniel@ipcpr.org.
FDA Announces Extension to Tobacco Related ANPRMs
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:
- The nicotine standard ANPRM comment deadline will now be July 16, 2018;
- The flavors ANPRM comment deadline will now be July 19, 2018, and
- The premium cigars ANPRM comment deadline will now be July 25, 2018.
For any questions concerning the ANPRM, please contact Daniel Trope, IPCPR Senior Director of Federal Government Affairs at daniel@ipcpr.org.