For Immediate Release:
October 9, 2023
Contact: Frank Coleman
(202) 258-7006
FColeman@CigarAssociation.org
CAA Strongly Opposes Latest Proposed FDA Tobacco Rule
Imposes Massive Burden on Manufacturers Without Any Public Benefit
Washington, DC Oct. 9 – The Cigar Association of America (CAA) today filed comments with the Food and Drug Administration (FDA) providing comments and suggestions on the agency’s proposed Tobacco Product Manufacturing Practice rule (Proposed TPMP Rule). The comments outline many areas of concern, including that as written the Proposed TPMP Rule would impose a massive financial burden on cigar manufacturers without any articulated public benefit.
While the Proposed TPMP Rule provides some flexibility, it was nevertheless written in a “one size fits all” fashion. It therefore fails to recognize that some provisions are simply not applicable to all products, including cigars.
“As a result,” CAA President David M. Ozgo pointed out, “while the Proposed TPMP Rule might provide flexibility, as written, cigar manufacturers would in many cases have to change current manufacturing practices without either any showing of need or benefit to the public health.”.
“That is simply nonsensical,” Ozgo stated. “It is costly and inefficient and serves no public health purpose.”
The Proposed TPMP Rule comes on the heels of a successful lawsuit against FDA brought by CAA and others in the cigar industry. Various court rulings in the case, from vacating the onerous and unjustified proposed health warning provisions on all cigars to vacating the Final Deeming Rule as to premium cigars (as defined by the court), admonished FDA for ignoring the science and not doing proper scientific investigation prior to rulemaking. Ozgo warned that the agency was again heading in that direction.
Ozgo added, “In the interest of public health, FDA should propose manufacturing practices that are appropriate to each product category. By doing so, each product category will be following rules designed to protect the public health based on the unique nature of the category, rather than being forced to comply with requirements that are inapplicable, unnecessary, or even counterproductive.”
Tobacco Control Act: FDA Has No Authority Over Agriculture
The comments note that the primary ingredient in cigars – tobacco — is an agricultural product grown on farms. These farms are located all over the world, often in second and third world countries. But the Tobacco Control Act specifically excludes from FDA authority anything to do with agricultural products, Ozgo noted.
“In fact, FDA has absolutely no legal authority over tobacco farms, or the tobacco grown on them until it crosses the threshold of a manufacturer making cigars for import into the United States,” he said.
The CAA comments, Ozgo noted, express concern that — once again — FDA does not recognize the limits of its authority. This is evident in FDA proposals that would require all ingredients, components, and finished tobacco products be traceable back to their original source and forward into domestic commerce.
While the forward-looking requirements represent costly challenges, the backward-looking requirements present even bigger problems given the various ways tobacco is sourced and used by cigar companies, he stated.
Ozgo said, “CAA is unaware of any widespread recall that the cigar industry has ever had to initiate due to manufacturing activities. All CAA member manufacturers have strict acceptance criteria for their tobacco. There should be no further requirements in any Proposed TPMP Rule related to tobacco used in cigars.”
The full comment can be found here.
CAA is a national trade association representing manufacturers, distributors, importers, suppliers, and all channels of retailers in the cigar industry, and traces its roots back to the 1890s.
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