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PCA Tells OMB to Remit Characterizing Flavor Rule Back to FDA

November 6, 2023 By Matthew Tabacco
FDA Updates

The Premium Cigar Association (PCA) testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the Administration’s review of the U.S. Food and Drug Administration’s (FDA) draft Final Rule “Tobacco Product Standard for Characterizing Flavors in Cigars.” OIRA’s role is to ensure that any new regulation is vetted for its economic and social cost-benefit, as well as to ensure that the regulation fits within the holistic policy goals of the Federal Government as a whole.

PCA President Scott Regina provided several examples of the real impact that the rule would have on specialty tobacco retail, emphasizing that FDA had not conducted a proper small business impact analysis. PCA also outlined how the rule would directly affect regulatory matters outside of FDA’s jurisdiction, including law enforcement, international trade, and foreign policy.

“It’s questionable whether FDA has the authority to issue standards that result in a product ban, especially when they are acknowledging that the regulation does not address a specific risk,” said Scott Regina, president of PCA.

“Ultimately, we asked OIRA to consult with a host of affected Federal Agencies and to remit the draft Final Rule back to FDA for better justification of authority, cost-benefit analysis, and small business impact,” said Scott Pearce, executive director of PCA.

OIRA has scheduled meetings with additional stakeholders throughout the month, as well as proponents of the characterizing flavor product standard for cigars.

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