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PCA Summary of FDA’s Proposed New Requirements for Tobacco Product Manufacturing Practices

March 14, 2023 By Matthew Tabacco
FDA Updates

The Premium Cigar Association has completed its initial analysis of the Proposed Rule for Tobacco product Manufacturing Practices published in the Federal Register on March 10th, 2023. The nearly 300-page document contains several provisions that will affect the “business of specialty tobacco retailing” both domestically in the United States and commerce internationally. Because a federal court has held that the FDA acted arbitrarily and capriciously in deeming premium cigars subject to the Act, it is the PCA’s position that FDA lacks jurisdiction to apply this rule to premium cigars. The PCA will urge the agency, and if necessary, the courts, to make clear that the proposed rule should not, cannot, and will not reach premium cigars. Furthermore, the proposed rule has several fundamental flaws in it that would inordinately harm smaller manufactures and lead to overall market contraction that would limit the products offered on retail shelves.

This is an economically significant rule that aims to apply a combination of standards used in the pharmaceutical and foods industries to tobacco products. This rule is far reaching in that it sets standards on international companies producing tobacco products and threatens to block importations of these products if the factories do not comply with widespread mandates that range from environmental standards to requiring the use of certain building materials. If the rule were to be implemented as written, you could expect the boutique cigar factories to be hit the hardest as well as producers of pipe tobacco.

The association is convening a working group of premium cigar manufactures and discussing the specifics of the proposed rule with our legal and regulatory teams to discuss the best course of action. The comment period will be open for at least 180 days and the association will be submitting a comment or comments. The scope of the comment(s) will be determined in the coming days after the proposed rule is fully vetted by relevant stakeholders and feedback is solicited/analyzed.

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