Congressmen Challenge FDA on Impact of New Regulations on Small Businesses

Congressman Dan Meuser, Chairman of the Small Business Subcommittee on Economic Growth, Tax, and Capital Access, and Congressman Roger Williams, Chairman of the House Committee on Small Business, have issued statements following their collective correspondence with Commissioner Califf of the Food and Drug Administration (FDA) concerning a new regulation and its potential negative effects on small businesses.

The congressmen’s letter stems from the House Committee on Small Business’s efforts to ensure federal agencies comply with the Regulatory Flexibility Act and the Small Business Regulatory Enforcement Fairness Act. These acts protect small businesses from onerous regulations and rulemaking processes.

The proposed rule aims to establish a product standard for cigars, banning all cigars with a “characterizing flavor” other than tobacco. This proposed regulation could significantly impact small businesses, especially those manufacturing or selling such flavored cigars.

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In the U.S., small businesses represent 99.9% of all businesses, underscoring the critical importance of considering the economic implications of new regulations on this significant sector. The Regulatory Flexibility Act mandates regulatory agencies to consider the impact of their rules on small businesses and to evaluate alternatives that would meet the objectives of the rule without unduly burdening small entities.

The Congressmen pointed out in their letter that they had reviewed the FDA’s May 2022 Preliminary Regulatory Impact Analysis regarding the proposed rule. However, they identified several unanswered questions they believe should have been considered when assessing the economic impact of the proposed rule.

The congressmen seek to understand the FDA’s consideration of the economic impacts on small entities from implementing this proposed rule.

This development reflects the ongoing dialogue between lawmakers and regulatory agencies about the impact of federal regulations on small businesses. It also underscores the critical role that legislative bodies play in scrutinizing proposed regulations, ensuring they do not unduly burden small businesses. For small business owners and entrepreneurs, this correspondence reminds them of the importance of staying informed about regulatory changes that could impact their operations.

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