Welcome!

News Feed Item

Cigar Association of America Submits Official Industry Comments on Food and Drug Administration Proposal to Regulate Cigars

WASHINGTON, Aug. 7, 2014 /PRNewswire/ -- Arguing for regulations that reflect "the unique character of the cigar industry," the Cigar Association of America, the national trade association representing cigar manufacturers, importers, distributors, and other suppliers, today submitted comments on Food and Drug Administration efforts to establish regulatory authority over the cigar industry.

The FDA has proposed to regulate cigars and other tobacco products under the Family Smoking Prevention and Tobacco Control Act. The move would create new legal and regulatory frameworks that would impact every element of the cigar supply chain, from manufacturers to end users.

"Our message to the FDA is that when it comes to regulating the cigar industry, fairness means flexibility," said CAA President Craig Williamson. "We believe a one-size-fits-all approach to regulation will endanger jobs, consumer rights and America's proud cigar tradition."

Following below is a summary of CAA responses to a variety of issues raised in proposed FDA regulations.

Section A: Comments

I. Path to Market: Path to market issues raised by the proposal are of critical importance to the cigar industry because they ultimately will affect the future viability of its members.

  •  Grandfather Date: FDA states that the grandfather date for purposes of substantial equivalence comparisons is February 15, 2007. CAA believes that date will unfairly disadvantage the cigar industry relative to the cigarette, smokeless, and roll-your-own industries, and will interfere with the cigar industry's ability to market new products and maintain currently marketed products for sale. CAA proposes that FDA use the date of the proposed deeming regulation, April 25, 2014, as the grandfather date. Doing so would place cigars on the same footing as currently regulated tobacco products that have a grandfather date of February 15, 2007, reflecting when manufacturers first became aware of the Congressional intent to regulate cigarettes, smokeless tobacco and roll-your-own tobacco.

If FDA insists on using February 15, 2007 as the grandfather date, then CAA proposes that the agency permit each tobacco manufacturer to identify product families of cigars that the manufacturer marketed on or prior to February 15, 2007, to establish predicate products for substantial equivalence comparisons whether or not the earlier products remain on the market. The submitted information for these predicate products would be reduced because typically such products would not exist to test.

What is highly important to the cigar industry is that it receives the same opportunity as cigarettes and other currently regulated products to keep its products on the market and maintain the opportunity to introduce new products.

  • Compliance Timeframes: The FDA proposes a 24-month compliance or transition period for submitting premarket submissions after the rule becomes final. CAA believes that this period should be contingent upon FDA's becoming current in its review of substantial equivalence reports; it should be extended further if 24 months after the rule's effective date a significant backlog of submissions remain.
  • Substantial Equivalence Considerations:
    • CAA proposes that blending changes due to natural variation should not require a new substantial equivalence report, and that new and predicate products with blending differences that are no greater than the blending differences within one product due to natural variation should be considered substantially equivalent.
    • CAA proposes a model that would require premarket review only when a new product family is developed; a product family would refer to cigars with the same type of tobacco blend, filler, and wrapper with different shapes and sizes.
    • CAA disagrees with FDA's current position that changes to a tobacco product's package or label render that tobacco product a "new tobacco product," requiring a substantial equivalence report. Packaging does not affect basic cigar characteristics.
    • CAA proposes that if a product remains the same, production location or ingredient supplier changes should not require a premarket report.
    • Due to conflicting compliance timeframes in the proposed rule (36 months from the effective date of the final regulation to submit a listing of HPHCs, but only 24 months to submit substantial equivalence reports). CAA proposes that, if FDA is going to require HPHC data in substantial equivalence reports, the agency should not require such reports until after these data are available. Even then, for initial submissions, the HPHC data should only be required of "new" tobacco products to create a HPHC baseline for future premarket submissions.

II. Health Warnings: CAA agrees with FDA's proposed health warnings, and requests that FDA clarify whether the Tobacco Control Act will preempt state law because California requires a warning that FDA believes is inappropriate. CAA also is concerned about the proposed size of the warnings on both cigar labeling and in advertising.

III. Sampling: CAA believes that, to the extent the agency intends to regulate cigar sampling, FDA should apply a sampling mechanism that is similar to that of smokeless tobacco products and would allow the distribution of samples in "qualified adult-only 3 facilities," as that term is defined in FDA's regulations. For premium cigars, FDA should apply a sampling mechanism that is designed to prevent youth access and exposure to tobacco products while permitting adults the opportunity to choose whether to take cigar samples.

IV. CAA agrees with the following parts of the proposal:

  • Minimum age and identification restrictions
  • The prohibition against adulteration or misbranding
  • Registration and listing requirements
  • Ingredient listings and HPHC reporting
  • FDA's premarket review of modified risk descriptors, or direct or implied claims of reduced/modified risk
  • Prohibition of vending machine sales in facilities where persons under the age of 18 could be present

Section B: CAA Supports Option 2 with a Revised Definition of Premium Cigar

CAA strongly supports Option 2 with the following revised definition: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) is made either by manually combining the wrapper, filler, and binder, or on a machine that has a production rate of less than 1,500 units per hour; (4) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; and (5) weighs more than 6 pounds per 1000 units.

This revised definition excludes price, and do not characterize flavors and primarily long filler tobacco as criteria because these criteria do not provide suitable certainty to define premium cigars. The revised definition also reflects that manual manufacturing (alone) is not appropriate for defining premium cigars; also, criterion 3 above was expanded to include low output machine made cigars because these are of the quality of hand-rolled cigars.

CAA proposes an alternative pathway for regulation under Option 1 if FDA decides to regulate premium cigars. Under the alternative pathway, premium cigars would be subject to some, but not all, of the requirements that apply to other deemed tobacco products. Premium cigars would not be subject to premarket review.

Section C: CAA Provides Feedback on How to Distinguish Cigarettes from Little Cigars

CAA provides information to assist FDA in addressing its concern that certain manufacturers may be labeling, packaging, or otherwise representing cigarettes as little cigars, cigarillos, or similar products.

Section D: Comments on FDA's Regulatory Flexibility Analysis

CAA provides comments on FDA's regulatory flexibility analysis, with an eye towards the costs and benefits of Option 1 and the small business considerations.

The Cigar Association of America, Inc. (CAA) is the national trade organization representing all segments of the cigar industry, including manufacturers, importers, distributors and other major suppliers.

Media Contact:
Craig Williamson
President, Cigar Association of America
(202) 223-8204
[email protected]

SOURCE Cigar Association of America, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Evatronix will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Evatronix SA offers comprehensive solutions in the design and implementation of electronic systems, in CAD / CAM deployment, and also is a designer and manufacturer of advanced 3D scanners for professional applications.
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone inn...
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
DevOps promotes continuous improvement through a culture of collaboration. But in real terms, how do you: Integrate activities across diverse teams and services? Make objective decisions with system-wide visibility? Use feedback loops to enable learning and improvement? With technology insights and real-world examples, in his general session at @DevOpsSummit, at 21st Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, explored how leading organizations use data-driven DevOps to close th...
"Digital transformation - what we knew about it in the past has been redefined. Automation is going to play such a huge role in that because the culture, the technology, and the business operations are being shifted now," stated Brian Boeggeman, VP of Alliances & Partnerships at Ayehu, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
"WineSOFT is a software company making proxy server software, which is widely used in the telecommunication industry or the content delivery networks or e-commerce," explained Jonathan Ahn, COO of WineSOFT, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Sanjeev Sharma Joins June 5-7, 2018 @DevOpsSummit at @Cloud Expo New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...