CRA Submits Formal Deregulatory Proposals to HHS to Protect Premium Cigars

On July 14, Cigar Rights of America submitted formal comments to the Department of Health and Human Services (HHS) in response to a Request for Information (RFI) entitled “Ensuring Lawful Regulation and Unleashing Innovation To Make America Healthy Again.” 

In its submission, CRA outlined several critical deregulatory actions HHS should undertake to protect premium cigars from future regulatory overreach. The proposal highlights the importance of codifying the industry’s recent legal victories, particularly the 2023 ruling that vacated the FDA’s authority over premium cigars, which was upheld on appeal earlier this year. Although the FDA’s Deeming Rule is no longer in effect for premium cigars, its provisions remain in the Code of Federal Regulations, leaving the door open for future administrations to revisit burdensome rules.

CRA’s submission urges HHS to take the following actions:

1. Formally Exempt Premium Cigars from the Tobacco Product Manufacturing Practice Rule: CRA called on HHS to exclude premium cigars from the FDA’s proposed manufacturing rule, citing the lack of any public health justification and the inappropriateness of applying pharmaceutical-style standards to a handcrafted agricultural product.
   
2. Clarify Exemption from User Fees: Despite the court ruling, some premium cigar manufacturers continue to receive invoices from the FDA for user fees they no longer owe. CRA requested that HHS issue clear guidance to confirm that premium cigars are not subject to these assessments and to prevent future billing or collections activity.
   
3. Issue Updated Policy Guidance on Premium Cigars: CRA encouraged the agency to recognize the findings of recent studies by the National Academies of Sciences and the Society for Research on Nicotine and Tobacco, both of which concluded that premium cigars have minimal youth appeal and distinct population health characteristics. CRA urged HHS to formally acknowledge premium cigars as a unique category of tobacco product.
   
4. Standardize the Definition of Premium Cigars Across All HHS Agencies: Finally, CRA called for the adoption of FDA’s eight-part definition of premium cigars across NIH, CDC, and all other relevant agencies. This would allow for consistent, science-based regulation and the collection of more accurate data in national health surveys.
   

This filing reinforces CRA’s commitment to protecting the premium cigar industry from inappropriate regulation and ensuring that handcrafted cigars are recognized for what they are: an artisanal product with distinct cultural, economic, and health characteristics. CRA will continue to advocate for clear and fair policies that respect the rights of adult consumers and small businesses nationwide.