CAA Submits Comments On FDA Proposed Regulations

cigars“Our message to the FDA is that when it comes to regulating the cigar industry, fairness means flexibility,” said CAA president.

Arguing for regulations that reflect “the unique character of the cigar industry,” the Cigar Association of America (CAA), the national trade association representing cigar manufacturers, importers, distributors, and other suppliers, has submitted comments on Food and Drug Administration (FDA) 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

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.

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.

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 three 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.

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% t 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 six pounds per 1,000 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 three 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.

 

 

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