The Premium Cigar Association (PCA) recently testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the ongoing review of the U.S. Food and Drug Administration’s (FDA) draft Final Rule titled “Tobacco Product Standard for Characterizing Flavors in Cigars.” The OIRA plays a crucial role in evaluating the economic and social impact of new regulations while ensuring alignment with the Federal Government’s policy objectives.
Key Points Shared by PCA:
PCA President Scott Regina raised several concerns during the testimony, emphasizing the potential impact of the proposed rule on specialty tobacco retailers. It was noted that the FDA had not conducted a thorough small business impact analysis. Additionally, PCA pointed out how the rule could affect areas beyond the FDA’s jurisdiction, including law enforcement, international trade, and foreign policy.
Scott Regina, PCA President, expressed doubts about the FDA’s authority to issue standards leading to product bans, especially when there is no specific risk addressed by the regulation.
Scott Pearce, PCA’s Executive Director, added, “Ultimately, we asked OIRA to collaborate with various Federal Agencies and send the draft Final Rule back to the FDA for a more comprehensive justification of authority, cost-benefit analysis, and small business impact.”
OIRA’s Ongoing Engagement:
OIRA has scheduled meetings with other stakeholders this month, including advocates of the characterizing flavor product standard for cigars.
PCA’s Recommendations to OIRA for the Characterizing Flavor Product Standard on Cigars
1. Weak Cost/Benefit Position: The PCA raised questions about the FDA’s authority to ban products using standards, especially when risk reduction is not demonstrated. Cigars represent a relatively small market, and the elimination of flavored cigars, while harmful to small tobacco retail businesses, is expected to have a nominal impact on smoking.
2. Impact on Multiple Agencies: The proposed rule’s influence extends to various agencies, including the State Department, Commerce Department, Customs and Border Protection, Bureau of Alcohol, Tobacco, Firearms, and the Small Business Administration.
3. Economic Analysis Deficiency: PCA requested the FDA to respond to questions posed by Chairman Roger Williams and Representative Dan Meuser regarding the impact of the rule on small businesses, with a specific emphasis on minority-owned small businesses and specialty retail tobacconists. An economic analysis of the impact on U.S. trade partners producing cigar tobacco or flavored cigars destined for the U.S. market was also suggested.
4. Alternative Solutions: PCA noted that FDA’s goals can be met without introducing new regulations. Specifically, the FDA’s delay in implementing Congressionally mandated regulations for Tobacco 21 was highlighted, with the expertise of specialty tobacco retailers being suggested to assist in effective guidance development.
PCA encourages OMB/OIRA to return the rule to the FDA with instructions to engage with relevant agencies and address the mentioned deficiencies before issuing a revised Proposed Rule.
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