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PCA Testifies Today Before the U.S. Food and Drug Administration

April 14, 2023 By Matthew Tabacco
FDA Updates

The Premium Cigar Association (PCA), represented by Deputy Executive Director/Head of Government Affairs Joshua Habursky, testified before the U.S Food and Drug Administration Center for Tobacco Products run by CTP Director Dr. Brian King. The association raised several objections against the “Requirements for Tobacco Products Manufacturing Practices.”Habursky’s full remarks are detailed below:

“My name is Joshua Habursky, and I am the Deputy Executive Director/Head of Government Affairs for the Premium Cigar Association. PCA is a trade association that represents over 3,000 brick-and-mortar retailers, over 30,000 retail employees and 250 associate member premium cigar manufacturers. Today, I am here to speak against the proposed rule.

“Because a federal court has held that the FDA acted arbitrarily and capriciously in deeming premium cigars subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act, it is the PCA’s position that FDA lacks jurisdiction to apply this rule to premium cigars. The PCA urges the agency to make it clear that the proposed rule should not, cannot, and will not reach premium cigars.

“This proposed rule seeks to find a problem where one does not exist. Where is the empirical evidence, consumer complaints or documented harm related to non-conforming premium cigars and pipe tobacco, which is the stated justification for this rule? FDA must provide such data on each tobacco product category in order to make serious and meaningful rule makings.

“What we know from the timing of this rule is that most of the background research was done at a time before FDA even deemed premium cigars or pipe tobacco to be FDA-regulated tobacco products. Since then, the agency has shown limited interest in understanding the nuances of distinct tobacco product categories, even failing to acknowledge the recommendations made by the National Academies of Science on its commissioned study, “Health Effects and Usage Patterns of Premium Cigars.” Therefore, it should come as no surprise that the proposed rule has several fundamental flaws in it that demonstrates FDA’s lack of understanding of the processes and conditions under which premium cigar and pipe tobacco are manufactured.

“This rule will place major environmental burdens on rural regions of South America, Africa and Southeast Asia. It will strain local infrastructure, where it exists. And it will drain critical resources from the developing economies from where these artisanal products originate. Furthermore, there has not been sufficient environmental impact analyses on the major construction work and transportation of materials to manufacturing facilities, which are predominately in rural regions, that compliance with the proposed rule for premium cigars and pipe tobacco would require. For example, it would be very difficult to put an industrial HVAC system into a 30-person premium cigar factory in rural Honduras. Even if the unit was available, the transportation, installation, energy consumption and maintenance will have significant environmental costs when multiplied across the industry.

“I would also like to highlight that this proposed rule would impose significant financial and administrative burdens disproportionately on small family-owned premium cigar and pipe tobacco manufacturers.

“Many of the requirements, modeled after pharmaceutical, medical device, and food regulations, are not appropriate for tobacco products. Others simply will not work for premium cigars or pipe tobacco specifically because these are artisanal, agricultural products produced in lesser developed countries that do not have the resources or existing infrastructure to comply with this proposed rule. It is clear that FDA has not consulted with coordinate agencies that manage U.S. trade and foreign policy interests in the countries where tobacco is a major economic resource. Implementation would ultimately have unintended consequences in these countries, such as rural unemployment, irregular emigration and black-market activity.

“The FDA needs to perform a rigorous domestic and international economic impact study and explain enforcement processes and procedures with greater detail. The FDA is not equipped to handle enforcement of this far-reaching rule, and other agencies have greater priorities and more important public policy issues to address.

“Finally, implementing and maintaining lab-like procedures and conditions will require major capital investments and ongoing maintenance costs, while being entirely unnecessary for products that have been manufactured in the same manner for hundreds of years. This would undoubtedly cause undue stress on small businesses, which are already struggling to maintain operations with rising costs and supply chain issues.

“Earlier this month Dr. Robert Califf told the House Energy & Commerce Committee that the FDA needs to “Educate Before They Regulate”. As it relates to this proposed rule, the FDA needs to educate itself a lot more before imposing a regulatory scheme with no value to the American public at a high economic and environmental cost.

“Thank you for giving me the opportunity to speak. PCA looks forward to engaging with FDA on this proposed rule and will also be submitting a more detailed written comment in opposition before the deadline.”

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