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SOURCE Cigar Association of America, Inc.
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.
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.
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:
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.
President, Cigar Association of America
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