Various members of the Cigar Industry had an opportunity to present oral feedback as a part of an Open Public Hearing to U.S. Food and Drug Administration (FDA)’s proposed requirements for Tobacco Product Manufacturing Practices (TMTP). Among the stakeholders who provided feedback on their participation were Joshua Habursky, Deputy Executive Director of the Premium Cigar Association; Drew Newman; J.C. Newman Cigar Company; and Dr. Gaby Kafie, Kafie 1901 Cigars.

The proposed requirements are aimed at tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. The rules are aimed at cigars, cigarettes, chewing tobacco, pipe tobacco, and vape products. From a cigar industry standpoint, these regulations target cigar factories and pre-industry facilities both domestic and foreign.

It is important to know that the input from this public hearing is used by the FDA to finalize the proposed rules as it sees fit. This feedback, along with written comment feedback, is a part of the process.

Harbursky’s testimony stated the PCA lacks jurisdiction to apply these regulations to premium cigars as a result of Judge Mehta’s ruling that the FDA acted arbitrarily and capriciously in deeming the regulation of premium cigars. He also pointed out the fundamental flaws (including one size fits all) with the FDA’s proposals, and highlighted the impacts this could have on foreign countries including administrative and financial burdens.

“My name is Joshua Habursky, and I am the Deputy Executive Director/Head of Government Affairs for the Premium Cigar Association. PCA is a trade association that represents over 3,000 brick-and-mortar retailers, over 30,000 retail employees and 250 associate member premium cigar manufacturers. Today, I am here to speak against the proposed rule.

“Because a federal court has held that the FDA acted arbitrarily and capriciously in deeming premium cigars subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act, it is the PCA’s position that FDA lacks jurisdiction to apply this rule to premium cigars.  The PCA urges the agency to make it clear that the proposed rule should not, cannot, and will not reach premium cigars.

“This proposed rule seeks to find a problem where one does not exist. Where is the empirical evidence, consumer complaints or documented harm related to non-conforming premium cigars and pipe tobacco, which is the stated justification for this rule? FDA must provide such data on each tobacco product category in order to make serious and meaningful rule makings.

“What we know from the timing of this rule is that most of the background research was done at a time before FDA even deemed premium cigars or pipe tobacco to be FDA-regulated tobacco products. Since then, the agency has shown limited interest in understanding the nuances of distinct tobacco product categories, even failing to acknowledge the recommendations made by the National Academies of Science on its commissioned study, “Health Effects and Usage Patterns of Premium Cigars.” Therefore, it should come as no surprise that the proposed rule has several fundamental flaws in it that demonstrates FDA’s lack of understanding of the processes and conditions under which premium cigar and pipe tobacco are manufactured.

“This rule will place major environmental burdens on rural regions of South America, Africa and Southeast Asia. It will strain local infrastructure, where it exists. And it will drain critical resources from the developing economies from where these artisanal products originate. Furthermore, there has not been sufficient environmental impact analyses on the major construction work and transportation of materials to manufacturing facilities, which are predominately in rural regions, that compliance with the proposed rule for premium cigars and pipe tobacco would require. For example, it would be very difficult to put an industrial HVAC system into a 30-person premium cigar factory in rural Honduras. Even if the unit was available, the transportation, installation, energy consumption and maintenance will have significant environmental costs when multiplied across the industry.

“I would also like to highlight that this proposed rule would impose significant financial and administrative burdens disproportionately on small family-owned premium cigar and pipe tobacco manufacturers.

“Many of the requirements, modeled after pharmaceutical, medical device, and food regulations, are not appropriate for tobacco products. Others simply will not work for premium cigars or pipe tobacco specifically because these are artisanal, agricultural products produced in lesser developed countries that do not have the resources or existing infrastructure to comply with this proposed rule. It is clear that FDA has not consulted with coordinate agencies that manage U.S. trade and foreign policy interests in the countries where tobacco is a major economic resource. Implementation would ultimately have unintended consequences in these countries, such as rural unemployment, irregular emigration and black-market activity.

“The FDA needs to perform a rigorous domestic and international economic impact study and explain enforcement processes and procedures with greater detail. The FDA is not equipped to handle enforcement of this far-reaching rule, and other agencies have greater priorities and more important public policy issues to address.

“Finally, implementing and maintaining lab-like procedures and conditions will require major capital investments and ongoing maintenance costs, while being entirely unnecessary for products that have been manufactured in the same manner for hundreds of years. This would undoubtedly cause undue stress on small businesses, which are already struggling to maintain operations with rising costs and supply chain issues.

“Earlier this month Dr. Robert Califf told the House Energy & Commerce Committee that the FDA needs to “Educate Before They Regulate”. As it relates to this proposed rule, the FDA needs to educate itself a lot more before imposing a regulatory scheme with no value to the American public at a high economic and environmental cost.

“Thank you for giving me the opportunity to speak. PCA looks forward to engaging with FDA on this proposed rule and will also be submitting a more detailed written comment in opposition before the deadline.”

Newman also spoke out against what the industry has said is the FDA’s “one size fits all policy”, the administrative burden of record keeping, and the challenges of qualifying suppliers.

Good Morning. My name is Drew Newman and I am coming to you from our 113-year-old El Reloj cigar factory in the Cigar City of Tampa, Florida. This is not a virtual background. Behind me we are handcrafting cigars just like my great-grandfather did when we founded our company in 1895.

I want to thank CTP for holding today’s public hearing and allowing small family businesses like ours to testify. I’ve read through the 300 pages in the Federal Register and, in my brief time today, I want to highlight four things:

  • Flexibility is essential
  • It’s a ton of records
  • Qualifying suppliers is difficult
  • Batch reports are hard

Flexibility is essential.

Throughout the proposed rule, CTP writes that the “proposed requirements are written in general terms” – an “umbrella approach” – to allow manufacturers to tailor them to their own businesses. This is essential. We are a 127-year-old cigar company. The way we handcraft cigars is so different from how cigarettes or ENDS products are made. A one-size-fits-all policy would crush our industry and the small businesses like ours that make up the majority of our industry. Therefore, please keep this flexibility in the final rule.

It’s a ton of records.

The proposal would require us to keep detailed records on everything we do, including training, cleaning, staff clothing, pest control, water, product testing, sampling, risk assessments, purchases, and so much more for 4 years. Honestly, this is a tremendous amount of records, work and cost for small businesses. We would have to hire new staff to record all of this.

Qualifying suppliers is difficult.

I’m very nervous about qualifying suppliers. We buy our tobacco from a collection of family farmers from around the world. For example, our Connecticut Broadleaf tobacco is grown by an 8th generation family farmer. Maintaining all of the detailed records of our own activities will be very hard. Doing the same and being responsible for the activities of our tobacco farmers, many of whom do not speak English and live in Latin America will be much worse.

Batch reports are hard

  • The proposal would require us to roll cigars in batches, keep detailed batch records, and put batch codes on every package. No one in our industry does this now, and it would be a big challenge to do so. Here is just one reason why:
  • When we roll cigars, we know when they were rolled and who rolled them. It’s on this production card.
  • We then age the cigars at least 6-12 months in our aging rooms. Sometimes a lot longer.
  • When they come back up to be packed, we mix cigars together and sort them by color so that when you open a box, every cigar inside is the same shade of brown.
  • This is how cigars have been made for more than 100 years.
  • Batching makes sense when you make, pack, and ship a product all at once. But for products like cigars that are aged and sorted, it’s a lot harder.
As I am running out of time, I’ll put the rest of our concerns in our written comments, but I have some final thoughts:
  1. My family has been rolling cigars the same way for 100 years.  The process hasn’t changed.  Our one goal is to roll cigars the same way for another 100 years.  We’ll fill out whatever paperwork and keep whatever records are necessary.  Just please give us the flexibility to continue rolling cigars like we’ve been doing since 1895.
  2. If you’d like to learn more, please visit us here in Tampa. Just like wineries and distilleries, we offer guided tours, cigar rolling classes and much more as we work to keep the centuries-old tradition of American cigar making alive.
  3. Cigars are just like wine.  They are a natural agricultural product.  Just like with wine, cigar tobacco varies greatly depending on the seed type and the soil where it is grown.  The amount of sunlight, wind, and rain also causes cigar tobacco to vary from year to year.  As cigar makers, we harness this natural variation to create unique and interesting cigars.  It’s an art, not a science.  There is no textbook or rulebook.  Instead, it’s a tradition that has been passed down from generation to generation.

Dr. Kafie spoke on behalf of the Boutique Cigar Association (BCA). While a transcript was not provided, the following points were made as a part of the hearing. Kafie says the BCA will be submitting official written comments. Kafie’s points included:

  1. Small family owned businesses can not afford FDA regulations.
  2. Premium Cigars are not the problem when it comes to tobacco.
  3. Premium Cigars are a poor delivery tool for nicotine.
  4. Premium Cigars are not used by minors
  5. Premium Cigars are not addictive
  6. There is no scientific evidence to demonstrate that premium cigars are bad
  7. The FDA needs to exempt premium cigars from regulations

The comment period for written comments is scheduled to close on September 6, 2023. A timetable of when the input is incorporated into a final rule has not been set, but the FDA says it becomes effective two years after it publishes the final rule to the Federal Register.