The Premium Cigar Association (PCA) has filed an official comment regarding the U.S. Food & Drug Administration’s (FDA) latest efforts to apply a one-size-fits-all regulation across the full spectrum of tobacco products. The proposed rule, “Tobacco Products Manufacturing Practice,” aims to establish standards for the manufacture, preproduction design validation, packing, and storage of all types of finished and bulk tobacco products. FDA states its intentions are aimed at preventing health issues that could be associated with contaminated or otherwise nonconforming tobacco products. However, the proposed rule falls short in its understanding of the diversity of tobacco products, where they are produced, and the effect that the proposed rule will have on areas of government beyond the FDA’s jurisdiction.
In response, PCA has posited five points of contention with the proposed rule and its application to non-premium cigars and pipe tobacco.
- FDA Has Failed to Demonstrate that the Harms, which the Proposed Rule Seeks to Address, exist.
- FDA Has Not Adequately Assessed the Proposed Rule’s Environmental and Economic Impacts on Cigar-Producing Countries or Small Businesses.
- Compliance is Out of Context or Inappropriate for Non-Premium Handmade Cigars and
Pipe Tobacco. - FDA Failed to Consider and Lacks the Capacity to Enforce the Proposed Rule.
- Misapplication of the Proposed Rule to Non-Premium Handmade Cigars and Pipe Tobacco Is Not Remedied by Proposed Variances or Exemptions.
PCA also referenced the Small Business Administration (SBA) Office of Advocacy’s official comment, which enumerated the shortcomings of the FDA’s proposed rule with respect to the Regulatory Flexibility Act. In July, PCA hosted a meeting with the SBA Office of Advocacy to discuss the impacts of the Proposed Rule and the FDA’s routine negligence to concerns of tobacco-related small businesses in rulemaking processes. Whenever an agency undertakes a new major regulatory change, the law requires that the holistic effects be studied and, specifically, that accommodations be considered for small businesses.
PCA is calling for the FDA to remove non-premium cigars and pipe tobacco from the proposed rule should the agency move forward with the regulation. Although Premium Cigars are presently exempt from FDA regulatory efforts, PCA has noted to the FDA that a new public comment period would be needed should the regulatory status change in the future.
“Good governance requires a willingness to understand the regulated industry,” said Scott Pearce, Executive Director of the Premium Cigar Association. “The FDA is going to continue to run into problems until they shed the notion that all tobacco products are the same.”