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Home » The Politics of Smoking


Please note that any information provided below is done so as a courtesy to Milan Tobacconists' customers and does not necessarily reflect the views or opinions of Milan staff.

Give us a call toll free at 877.70MILAN or send an email to customercare@milantobacco.com if you have questions, concerns, or comments!

Learn the latest on Virginia and national political issues regarding smoking.

Please click on the links below to view an announcement of particular interest or scroll down the page to view all announcements:

»  Virginia Premium Cigar Smokers ~ Take Action Now! (2/13/24)
»  Your Historic Victory Against FDA! (8/10/23)
»  Speak Out Against FDA's Proposed Regulations! (5/3/23)
»  Virginia Cigar Tax Cap Setback ~ For Now. (1/26/23)
»  Virginia Premium Cigar Smokers ~ Take Action Now - Part II! (1/19/23)
»  Virginia Premium Cigar Smokers ~ Take Action Now! (1/11/23)
»  Court Rules FDA Acted Improperly Regarding Regulation of Premium Cigars (7/5/22)
»  Say "NO" to a Ban on Flavored Cigars! ~ UPDATED (6/17/22)
»  FDA Announces Proposed Flavored Cigar Product Standards Rule (4/28/22)
»  CRA Public Statement on NASEM Premium Cigar Panel Findings (3/11/22)
»  Tobacco Tax Equity Stripped from the Build Back Better Act (10/28/21)
»  Tell Congress NO To Tobacco Tax Hikes ~ UPDATED (9/24/21)
»  Oppose Federal Tax Increase on Premium Cigars & Pipe Tobacco (4/7/21)
»  CRA & PCA Statement On Release Of Premium Cigar SE & PMTA Final Rule (1/20/21)



Virginia Premium Cigar Smokers ~ Take Action Now! (2/13/24)

Tax caps on premium cigars are listed as budget items in Virginia's Senate Bill 30 and House Bill 30 and both are under consideration by your legislators this week! We're calling on our loyal Virginia customers to voice your support of the recommended $0.30 tax cap TODAY to help family-owned small businesses across the Commonwealth compete against lower-cost alternatives in neighboring states. Please take just a few minutes to send your message in support of a premium cigar tax cap -> Support a Cigar Tax Cap in Virginia!

Thank you in advance for joining the fight to keep your cigars from being unfairly taxed!

Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Your Historic Victory Against FDA! (8/10/23)

Before we share this exciting press release from Cigar Rights of America (CRA), we want to express our deepest thanks to our amazing customers and fellow CRA members for continuously supporting all efforts to protect premium cigars no matter how impossible the outcome we sought might have seemed. Congratulations to all on this hard-won victory!

David and Renée Meyer
Milan Tobacconists, Inc.

From the CRA: Yesterday's final decision by US District Judge Amit P. Mehta in CAA et al v FDA (plaintiffs Cigar Association of America, Cigar Rights of America, and Premium Cigar Association), completely struck down all U.S. Food & Drug Administration (FDA) regulations on premium cigars. This is a historic day for our industry and the culmination of fifteen years of meticulous work and tens of thousands of man-hours by Cigar Rights of America (CRA). CRA solely funded and led this final challenge that has now accomplished the most significant tobacco regulatory repeal in modern history. We are thrilled to announce this victory, which was made possible by your commitment and support of CRA as we have worked to protect your rights to make and enjoy premium cigars.

The foundation of this decision stretches back to two key arguments established by CRA in our 2014 advocacy against the FDA's Deeming rule. At that time, we presented scientific evidence that premium cigars are different, and FDA should consider exempting them. We showed that premium cigars are not used by youth and FDA had failed to show any evidence that they posed increased risks of mortality. Based on that science, our regulatory and lobbying teams were able to pressure FDA into including an exemption, Option 2.

Although the Agency decided to ignore that evidence, Judge Mehta specifically cited CRA's comments as providing "multiple reasons for selecting Option 2" and found that FDA "failed to consider data before it [which had been presented by CRA] concerning the use of premium cigars." FDA's failure to answer our challenge led Judge Mehta to find that the Agency had acted "arbitrarily and capriciously" and to order that premium cigars be immediately removed from FDA's power entirely.

What's Next for Premium Cigars
FDA will have 60 days to appeal Judge Mehta's ruling, but with no evidence or science to support their case, we do not expect them to do so. Should they choose to appeal, we are confident that we will ultimately prevail and will be completely exempt from FDA's rules, requirements, and fees.

With respect to the "User Fees" that manufacturers have paid to the Agency since 2016, and which Judge Mehta estimates at $15 - 20 million per year, the ruling anticipates that we will be exempt from payment in the future. [See note below] Whether this action might open the door to recouping the fees manufacturers have already paid remains to be determined, but will be closely watched. Turning away FDA's concern with this outcome, he stated that "[o]n balance, the future fallout that the FDA may face from vacatur does not outweigh the financial and other burdens the premium cigar industry has had to shoulder."

While today is a day for our community to celebrate, we must remain vigilant and aware that FDA will not rest. Although this ruling will exempt premium cigars from all current FDA regulation, the Agency retains the right to start from scratch and begin the process all over again.

With the wind of this decision at our backs, CRA will not stop our work to prevent that from happening. We will meet with FDA in coming days to press them to drop premium cigars from their strategic plan; we will stave off increases in taxation of our products; and we will ensure that our products are separated out of Federal law. With your continued support and the facts on our side, I know that we will continue to succeed in that mission.

In gratitude,
Michael E. Copperman
Director of Regulatory and Legislative Affairs
Cigar Rights of America

Courtesy of CRA of which Milan Tobacconists is a member. To learn more about the CRA, please visit www.cigarrights.org.


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Speak Out Against FDA's Proposed Regulations! (5/3/23)

The Premium Cigar Association (PCA) is reaching out to retailers and consumers of cigars and pipe tobacco about a matter of significant importance to the tobacco industry. The U.S. Food & Drug Administration's (FDA) Center for Tobacco Products (CTP) proposed a new regulation on tobacco product manufacturing that could have severe consequences for all of us, but particularly for small business manufacturers.

The proposed standard will require manufacturers to make unnecessary and burdensome investments in new equipment, new procedures, compliance, and additional personnel. These costs will be significant and ongoing, resulting in higher prices at the wholesale and retail levels. It is important to emphasize that the FDA has not provided evidence supporting the need for this new regulation and has yet to present data on incidents or illnesses caused by nonconforming premium cigars and pipe tobacco.

The proposed regulations also impose a seed-to-smoke tracking requirement for every premium cigar and a controlled system for managing the return and disposition of tobacco products to the manufacturer. These resource-intensive and intrusive burdens mimic how FDA manages pharmaceuticals, which is clearly inappropriate for tobacco. It will devastate small manufacturers overseas, limiting supply and increasing costs for small business retailers in the United States.

We urge you to take action and sign the petition below against this proposed rule and voice your concerns to the FDA in support of small businesses across the United States and the world. Thanks in advance for your support!

Sign the Petition Here!

Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Virginia Cigar Tax Cap Setback ~ For Now. (1/26/23)

Yesterday's outcome in Virginia's General Assembly was not quite what we tobacconists and our premium cigar customers hoped for and rallied together in support of, but we do have some good news to share. House Bill 1417 was successfully ushered through the House by Delegate Lee Ware with an impressive showing of bipartisan support for the $.30 tax cap legislation! HB1417 has cleared the House and now will be sent to the Senate.

Unfortunately, Senate Bill 992 did not survive its journey despite every effort by the bill's sponsor Senator Frank Ruff to garner his colleagues' support for the tax cap. The bill was passed over indefinitely by committee, essentially putting an end to SB 992.

Thank you everyone for pulling out all the stops to voice your support for these two bills and asking your fellow cigar enthusiasts to do the same. Yes, we've had a setback, but the "fight" isn't over yet. Please be ready to turn up the pressure again in the not-to-distant future!

David and Renée Meyer
Milan Tobacconists, Inc.


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Virginia Premium Cigar Smokers ~ Take Action Now - Part II! (1/19/23)

Your incredible support has helped move along House Bill 1417 [$0.30 tax cap on premium cigars] in the Virginia General Assembly! BUT, that's not the case with Senate Bill 992 and we only have 4 days to make some noise! The legislation is now before the Senate Finance and Appropriations Committee, so please take a minute to send a prewritten message to these committee members TODAY asking them to support SB 992. -> Ask Senate Committee to Support a Cigar Tax Cap in Virginia!

Thank you for rallying with us on this critical legislation!

Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Virginia Premium Cigar Smokers ~ Take Action Now! (1/11/23)

The Virginia General Assembly has introduced a $0.30 tax cap on premium cigars under House Bill 1417 (Delegate Lee Ware) and Senate Bill 992 (Senator Frank Ruff)! These bills are being assigned to subcommittees now and are expected to be heard fairly soon. To help the bills gain traction, we're calling on our loyal Virginia customers to voice your support of the tax cap TODAY because we have no doubt that your actions will go a long way toward pushing the tax cap through.

Help Virginia's family-owned small businesses like Milan Tobacconists compete with lower-cost alternatives in neighboring states by taking just a few minutes to send your message in support of Virginia tobacconists -> Support a Cigar Tax Cap in Virginia!

Thank you in advance for joining the fight to keep your cigars from being unfairly taxed!

Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Court Rules FDA Acted Improperly Regarding Regulation of Premium Cigars (7/5/22)

From the CRA: A little over one month ago, Cigar Rights of America ("CRA") appeared in Federal Court to challenge the FDA's decision to regulate premium cigars. Today, United States District Judge Amit P. Mehta ruled that the FDA's decision to regulate premium cigars was arbitrary and capricious in violation of the Administrative Procedure Act.

Regarding the handling of CRA-submitted information, the Court held that "instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue: '[T]here were no data provided to support the premise that there are different patterns of use of premium cigars and that these patterns result in lower health risks.' That statement was not accurate then, and despite litigation counsel's efforts, it is not accurate now." The Court continued: "Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it."

The Court also criticized the agency's handling of data regarding whether youth use premium cigars.

Gary Pesh, Chairman of CRA, stated "Today's federal court opinion is consistent with CRA and PCA's long-held contention that FDA acted arbitrarily and capriciously when it decided to regulate premium cigars in the first place." Pesh continued, "CRA funded and pursued this direct challenge and are grateful for the hard work that the CRA legislative and legal team have undertaken to explain the errors in the FDA's decision to regulate premium cigars."

The Court has instructed both parties to file briefs on the question of the appropriate remedy by July 26, 2022.

Courtesy of CRA of which Milan Tobacconists is a member. To learn more about the CRA, please visit www.cigarrights.org.


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Say "NO" to a Ban on Flavored Cigars! ~ UPDATED (6/17/22)

The FDA issued the following statement today: "FDA is extending the comment period to a total of 90 days following requests from the public. FDA also received requests to not extend the comment period from public health organizations. However, FDA believes that a 90-day comment period is appropriate as it allows adequate additional time for people to fully consider the proposed rules, including specific requests for comments, and develop and submit comments without significantly lengthening the rulemaking proceedings." This extends the formal comment period from July 5, 2022, to August 2, 2022.

Cigar Association of America (CAA) has provided a portal through which cigar smokers may share their opinion directly with the U.S. Food & Drug Administration (FDA) regarding the agency's proposed ban on flavored cigars [see next article for details]. The FDA's formal comment period closes on July 5, 2022 [now August 2, 2022].

"It is unfortunate that in public policy debates, the average adult consumer is often given little say in the matter," said David Ozgo, CAA president in a press release. "We developed this portal to give adult consumers a voice on this important issue."

As a premium cigar smoker of legal age, we believe you should have the choice of which legal products you wish to enjoy and hope you'll take a minute right now to easily share your comments with the FDA by visiting the CAA Portal Here -> CAA Secure Portal

Thank you in advance!

David and Renée Meyer
Milan Tobacconists, Inc.

Portal Courtesy of Cigar Association of America ~ a non-profit trade association for the cigar industry founded in 1937. To learn more about CAA, please visit www.cigarassociation.org.


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FDA Announces Proposed Flavored Cigar Product Standards Rule (4/28/22)

From the PCA: Today, the Food & Drug Administration and the Center for Tobacco Products (CTP) announced their "Tobacco Product Standard for Characterizing Flavors in Cigars" proposed rule, which would prohibit characterizing flavoring in all cigars.

On March 10th the Premium Cigar Association (PCA) was the first stakeholder group to meet with the Office of Management & Budget, Office of Information & Regulatory Affairs, and Food & Drug Administration to raise concerns about this pending rule, ask for clarification on the specifics, and make recommendations about further research on international implications and impact on small businesses. PCA asserts that the agency still has left many questioned unanswered, specifically on: 1) characterizing flavor descriptors; 2) total small business impact; 3) foreign impact in cigar producing countries; and 4) impact on minority owned small businesses.

"The FDA failed to do their homework in this rule and the document is filled with cherry-picked data that mirrors spoon fed talking points from anti-tobacco groups. The proposed rule is a mess that is ripe with potential challenges and reflective of an agency that is unable to prioritize its resources appropriately." said Greg Zimmerman, president of the PCA.

As the process continues PCA, will: 1) challenge the necessity of a prohibition; 2) showcase negative retail impact; 3) argue for a solidified and long-term inventory turnover period; 4) maintain that the rule does not affect pipe tobacco; and 5) argue for clarity surrounding characterizing descriptors.

"As we move through the regulatory process, PCA will continue to engage with the FDA and policymakers to shed light on industry concerns. Chief among our concerns remains the ability to describe "premium cigars," which are non-flavored, with descriptors that accurately describe the natural variances in tobacco flavor. We aggressively assert this is a free speech issue. Whether you are an individual company crafting shelf talkers or a major media publication, you should be free to describe the product's profile accurately," said Joshua Habursky, PCA deputy executive director and head of government affairs.

The Premium Cigar Association intends to participate in the public comment process that will include two public listening sessions on June 13th and June 15th. The docket for comments will be open beginning May 4th and will be open until July 5th. The Premium Cigar Association staff has put together a Frequently Asked Questions document that summarizes the 187-page rule and it's applicability to retailers, manufacturers, and connection to premium cigars, which may be found here -> PCA's FAQ on FDA Proposed Rule

Full FDA Proposed Rule Text Here.

Information and Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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CRA Public Statement on NASEM Premium Cigar Panel Findings (3/11/22)

This week, the National Academies of Sciences, Engineering, and Medicine's ("NASEM") Committee on Patterns of Use and Health Affects of "Premium Cigars" and Priority Research released their highly anticipated report examining premium cigars. The resulting report, "Premium Cigars: Patterns of Use, Marketing, and Health Effects", generated 13 findings, 24 conclusions, and nine priority research recommendations to the Food and Drug Administration.

Cigar Rights of America ("CRA") wishes to thank NASEM for the completion of their year-long endeavor that resulted in their published report. CRA participated with NASEM from the start by testifying before their panel committee and submitting comments that embody years of research representing a professional, exhaustive review of the scientific literature.

We are encouraged by a number of findings regarding consumption patterns, frequency of use, inhalation patterns, and distinctions with other tobacco categories that compliment our historic arguments in service of exempting premium hand rolled cigars from FDA deeming regulations. NASEM reflects this understanding in their finding that concludes, "premium cigars are different than other tobacco products based on usage patterns."

Moreover, we agree with the premium cigar definition memorialized by this report. It remains consistent with qualities we affirm best represent the nature of a premium cigar. We are further pleased by the removal of an economic quantifier that had no precedent at FDA, would have been difficult to enforce, didn't allow for the complex relationship of retail prices and differing taxes at the national, state, and municipal level, and excluded the majority of the premium cigar market.

CRA continues to have serious concerns with the interpretation of the data and the conclusions drawn with regards to health effects. It remains the case that premium cigars continue to be conflated with other tobacco products. We strongly maintain that there is sufficient data and has been since 2014 to conclude that the mortality, morbidity, and youth usage and access experience of premium cigar patrons don't warrant inclusion in the FDA deeming regulatory framework. The Population Assessment of Tobacco Health studies and Center for Disease Control youth risk surveys as well as the FDA's acknowledgement that premium cigars were their lowest enforcement priority due to the lack of youth usage and access issues further underscores this point.

FDA's proposed deeming of premium cigars has no discernable benefits at the population risk level, tremendous costs that threaten the existence of our industry, and serious unintended consequences for industry and manufacturing nations alike. CRA continues to assert that FDA should exempt premium cigars from their regulatory framework. At minimum, FDA should suspend any further regulations upon the industry.

One of the FDA's key rationales for commissioning NASEM was to assess data that may be used in service of underlying the pre-market tobacco application regime. The request for 9 areas of further research and the time it takes for completion and analysis ought to coincide with FDA discontinuing any further applications of regulation upon premium cigars. The CRA Board of Directors commented on this development, "CRA looks forward to continued discussions with Congress and the Administration in service of exempting premium cigars from FDA regulations. Today's memorializing of a premium cigar definition was one move in the right direction."

The Cigar Rights of America Board

View the report here -> NASEM Report

Courtesy of CRA of which Milan Tobacconists is a member. To learn more about the CRA, please visit www.cigarrights.org.


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Tobacco Tax Equity Stripped from the Build Back Better Act (10/28/21)

Finally, a victory thanks in no small part to our customers across the country contacting your representatives on Capitol Hill to let them know the proposed tax increases on your cigars and pipe tobacco were unacceptable!

From the PCA: "Tobacco Tax Equity has been a top priority by anti-tobacco activists seeking to price informed adult consumers out of the market. Under the false premise that all tobacco products are interchangeable and equally hazardous to health, it would have fundamentally changed the current risk-based tax formula. The new formula would equate all tobacco products to cigarettes, then double the tax! The result would be up to 1,000% increase in federal excise tax for cigars and 1,650% increase in federal excise tax for pipe tobacco.

"The anti-tobacco groups fed Congress a lot of half-truths, and frankly there are some powerful officials that enabled it," said Joshua Habursky, Head of Government Affairs at PCA. "Initially, very little consideration was given for how this would affect lower income and minority populations, small businesses, unemployment, foreign relations, immigration, or even public health for that matter. A lot of Congress members weren't happy about the position they were put in."

PCA began lobbying against Tobacco Tax Equity in February of this year, when Senator Durbin (D-IL) proposed it as a means to pay for maternal health programs. The threat evolved into a stand-alone bill in March before being proposed as a means to pay-for the Build Back Better Act. The effort has included over 100 meetings in Washington D.C. and collaboration with allied associations in the States. PCA also developed a grassroots engagement platform that gave voice to over 25,000 cigar and pipe enthusiasts contacting Capitol Hill. In October, PCA hosted a Global Policy Summit with U.S. Senators, foreign dignitaries, and international industry leaders. The discussion led to engagement with the White House on the deeper economic effects that the policy would have on our Central American allies and trade partners including the direct opposition of these provisions by the Minister of Trade & Industry for the Dominican Republic.

"This campaign proved how strong we are when the industry comes together as one family," said Greg Zimmerman, President of the Premium Cigar Association. "I'm grateful for our retail members, manufacturers and the everyday consumers who participated in this campaign. It started with great lobbying here in D.C., but the strength of those messages resonated because Members of Congress and Senators realized that PCA represents real business owners, real employees and real voters."

The House of Representatives will soon begin debate on this latest version of the Build Back Better Act, with the Senate to follow suit.

"At the end of the day, Tobacco Tax Equity isn't about raising money for social programs; it's about an elite interest group that wants to destroy our industry." said Scott Pearce, Executive Director of the Premium Cigar Association. "If you look at how these groups are funded, it's clear they still wield a lot of political power. This could circle back around. So we won't be letting up."

PCA is still encouraging its members and our customers to take action on an updated alert to stave off that threat of the anti-tobacco groups pushing these harmful provisions back into the Build Back Better agenda. Please take action now -> Keep Up the Pressure!

Thank you so much for joining the fight to keep your cigars and pipe tobacco from being unfairly taxed!

Information and Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Tell Congress NO To Tobacco Tax Hikes ~ UPDATED (9/24/21)

The House Ways & Means Committee has passed the tax proposal package as introduced, meaning that all Republican amendments to the bill were defeated and the Democrats offered none. The proposal is now with the House Budget Committee, where they are waiting on negotiations between House and Senate Democratic leadership and the White House before the legislative process proceeds. Once the legislation clears the Budget Committee, the bill will transit to the House Rules Committee ~ the last stop before consideration of the bill by the full House.

Negotiations on the proposal are continuing to take place behind the scenes, but your vocal opposition to this increased tax on premium cigars and pipe tobacco is so critical now! Remember, the proposed tax increase under consideration in Congress could see tax increases in excess of 1,000% for premium cigars and pipe tobacco. This is a credible threat that should not be ignored. Please contact your members of the U.S. House of Representatives and U.S. Senate TODAY if you haven't already -> Ax the Tax Hikes! Thank you for your support.

The House Ways & Means Democratic staff has begun circulating a list of priorities and revenue raisers for the "Human Infrastructure" bill that will be voted on in coming weeks through the reconciliation process that only requires a simple majority (51 votes) in the Senate. This is the first step in this process and, unfortunately, the committee's priorities include a $96 billion tobacco tax increase that would likely include both premium cigars and pipe tobacco among other products.

Tuesday (9/14/21), the Ways & Means Committee members will be meeting to discuss their priorities. It is critical that premium cigar consumers, retailers, and manufacturers contact Congress to oppose these detrimental tax increases, especially in committee members' districts.

Over the course of the last 24 hours, the level of threat has risen as Congress considers new ways to raise revenue to pay for sweeping new programs. While taxes on the nation's wealthiest citizens is a primary target, some in Congress are using this moment to press for tax increases on tobacco as a whole and premium cigars and pipe tobacco specifically.

The threat of rolling Senator Dick Durbin's "Tobacco Tax Equity Act" into some of the packages under consideration is real. This action could result in a 1000% tax increase on premium cigars, and a 2,100% increase on pipe tobacco. Their goal: To raise $96 billion in tobacco taxes alone. This comes at a time of regulatory uncertainty and in the midst of a national economic recovery. It's an attack on American small businesses like Milan Tobacconists and a threat to the economies and political stability in some of the most fragile nations in this hemisphere.

Please contact your members of the U.S. House of Representatives and U.S. Senate TODAY -> Say NO to Tobacco Tax Hikes!

Information and Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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Oppose Federal Tax Increase on Premium Cigars & Pipe Tobacco (4/7/21)

U.S. Senator Durbin (D-IL) has reintroduced a massive tobacco tax increase as part of a bill that is otherwise intended to address maternal mortality. Buried within S.411 - the Mothers and Offspring Mortality and Morbidity Awareness Act (MOMMA's Act) - are changes to the tax code that would treat the entire tobacco industry as though it was a singular producer of cigarettes. The result is an estimated 500% - 1,000% increase on the tax for premium cigars (depending on size) and a 1,650% increase on the tax for pipe tobacco! If passed, the changes included in S.411 would go into effect by the end of this year.

A tax this big isn't just lost profit. This bill will raise the costs for manufacturers, retailers, and consumers. Jobs, businesses, and your ability to purchase and enjoy a premium cigar or pipe tobacco will be at risk. Please take action now by letting your U.S. Senators know that S.411 (MOMMA's Act) shouldn't be paid for on the backs of the premium cigar and pipe tobacco industries. It only takes a minute: Take Action Now!

Information and Link Courtesy of the PCA of which Milan Tobacconists is a member. To learn more about the PCA [formerly IPCPR], please visit www.premiumcigars.org.


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CRA & PCA Statement On Release Of Premium Cigar SE & PMTA Final Rule (1/20/21)

Cigar Rights of America (CRA) and the Premium Cigar Association (PCA) have issued the following joint statement:

Last night, the Food & Drug Administration (FDA) and the Center for Tobacco Products (CTP) released the Final Substantial Equivalence (SE) and Premarket Tobacco Product Application (PMTA) Rules to address deemed products. While the rules apply regulations to a wide variety of products, FDA stopped short of applying the new regulations to "premium cigars" acknowledging that the agency is evaluating industry comments and its own research on the category.

"... at this time, FDA is not finalizing the proposed SE rule with respect to "premium" cigars. Rather, FDA will take appropriate action once it has further considered the comments submitted to the deeming rule docket that suggested FDA create a streamlined SE process for "premium" cigars..."

The Final Rule reflects targeted efforts by Premium Cigar Association (PCA) and Cigar Rights of America (CRA) over many years to educate FDA, CTP, and White House officials with category specific data on premium cigars as they relate to public health risk for youth and nicotine addiction and urging them to exclude premium cigars from regulations that are ill-suited to the category. The Final Rule also builds upon the federal court ruling that FDA failed to fully evaluate the comments it had received during its proposed rulemaking on premium cigars before taking action to regulate the category.

Yesterday's release notes, "As discussed in section V.C.1 of this final rule, we are adding the Cigar Ass'n of Am.court's definition of "premium" cigars to ยง 1107.12. That definition is:

"Premium" cigars means a type of cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units."

This is an important victory for the associations and will provide a formative definition for future use at both the federal and state levels in the legislative and regulatory process.

"This is the result of a continued effort in the courts and educating lawmakers and regulators about our industry by the PCA and CRA teams," said Scott Pearce, Executive Director of the Premium Cigar Association. "How this industry is defined ultimately determines how it is regulated and the public health risk data for premium cigars simply doesn't compare to that of other deemed products."

Robert Levin, Chairman of CRA, added, "The release of the Final Rule is a culmination of years of advocacy work in Washington that laid the groundwork for a specific and distinct definition of premium cigars that is now part of a federal definition."

Courtesy of CRA of which Milan Tobacconists is a member. To learn more about the CRA, please visit www.cigarrights.org.


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