Urgent Action Needed: Oppose FDA Proposed Rule on Manufacturing Practices


The Premium Cigar Association (PCA) is reaching out to you today to bring to your attention a matter of grave importance to the industry. The U.S. Food & Drug Administration’s (FDA) Center for Tobacco Products (CTP) proposed a new regulation on tobacco product manufacturing that could have severe consequences for manufacturers, retailers, and consumers. This proposed regulation would have a particularly negative impact on small business manufacturers.

We urge you to take action and sign the petition below against this proposed rule and voice your concerns to the FDA in support of small businesses across the United States and the world in premium cigar-producing countries.  

The proposed standard will require manufacturers to make unnecessary and burdensome investments in new equipment, new procedures, compliance, and additional personnel. These costs will be significant and ongoing, resulting in higher prices at the wholesale and retail levels.  

It is important to emphasize that the FDA has not provided evidence supporting the need for this new regulation. The FDA has yet to present data on incidents or illnesses caused by nonconforming premium cigars and pipe tobacco. The proposed manufacturing standard is a solution in search of a problem.  

Furthermore, the proposed regulations impose a seed-to-smoke tracking requirement for every premium cigar and a controlled system for managing the return and disposition of tobacco products to the manufacturer. These resource-intense and intrusive burdens mimic how FDA manages pharmaceuticals, which is clearly inappropriate for tobacco. It will devastate small manufacturers overseas, limiting supply and increasing costs for small business retailers in the United States.  

We urge you to speak out against these proposed regulations! By signing the petition below, you agree to voice opposition to the proposed regulation. Your name will be submitted with a cover letter to the Center for Tobacco Products and the open public comment docket before the September 6th deadline. Please note that anyone can sign this petition. Still, we urge manufacturers to submit original comments directly to the FDA and have provided resources below on that process.  

We must come together as an industry to fight against this proposed regulation and protect small businesses. Please sign the petition below, share this with your friends or customers, and spread the word about this critical issue.  

Thank you for your support.
If you would like to submit a unique comment to the FDA opposing this proposed rule, we recommend clicking following links for additional information and resources:

PCA’s Summary of the Proposed Rule
PCA’s Oral Comment to the FDA
PCA’s Submission Portal for Manufacturers
How to Submit a Public Comment
FDA’s Comment Submission Portal