Two weeks ago, the U.S. District Court for the District of Columbia struck down FDA’s regulation of premium cigars. This was a major victory for the premium cigar industry. Because FDA still has the legal authority to try to re-regulate premium cigars now or in the decades ahead, we must remain vigilant and continue to work to protect our right for adults to enjoy a premium cigar. This morning, Drew Newman testified before FDA regarding its strategic plan via Zoom from the rolling room of our El Reloj cigar factory in Tampa. Below are his remarks to FDA.

“Good Morning — My name is Drew Newman of J.C. Newman Cigar Co. 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 he founded our company in 1895.

I want to thank CTP for holding today’s listening session and allowing small family businesses like ours to speak and share our views on the proposed goal areas of CTP’s Strategic Plan.  I’ve read through CTP’s five draft goal areas that Dr. King mentioned and want to offer three things for your consideration:

1. Please remember the continuum of risk.
2. We’re an industry full of small businesses.
3. Compliance should include support, not just enforcement actions.

1. Continuum of risk.

When he announced his comprehensive regulatory plan for tobacco products in 2017, former Commissioner Gottlieb said, “we must acknowledge that there’s a continuum of risk for nicotine delivery.” He noted that different products can have different levels of harm. Instead of taking a one-size-fits-all approach for all tobacco products, Dr. Gottlieb directed the CTP to tailor its work to fit the unique characteristics of different types of tobacco products. He also directed the agency to focus its limited resources on the parts of the products in the continuum that have the greatest risk.

In reading CTP’s draft goal areas, I am concerned that this philosophy has been overlooked. As CTP continues drafting its strategic plan, please recognize that tobacco includes a wide range of products and adopting a one-size-fits-all policy will not work. Please also include the continuum of risk in your strategic plan. Please let the continuum of risk guide the agency and direct CTP’s limited resources so they can be used in the most efficient and effective way possible.
 

2. We’re an industry full of small businesses.

Sec. 900 of the Tobacco Control Act, Congress recognized that there are “Small Tobacco Product Manufacturers.” Sec. 901 directs FDA to establish an office to assist small businesses like ours that manufacturer tobacco products, and Sec. 906 provides extra time for small businesses to comply with new regulatory requirements. I am concerned that CTP’s draft goal areas don’t reflect that we are an industry full of small businesses.

Of course, there are big tobacco companies. However, I would bet that there are there are thousands of small businesses like ours that grow, make, or sell tobacco for every giant tobacco company. For example, we buy our tobacco leaves from small family companies around the world, and the vast majority of our cigars are sold by 3,000 family-owned brick and mortar premium cigar stores in the USA.
As you continue to work on CTP’s Strategic Plan, please remember that the vast majority of tobacco companies are small businesses, and that Congress did not want the agency to overlook them.
 

3. Compliance should include support not just enforcement actions.

The proposed the goal area on compliance is pretty intense. What I read is an aggressive focus on going after bad actors. Of course, there are bad actors in every industry and CTP should have robust tools to address them. However, compliance should include more than just legal actions and penalties.

I believe that most people in this world are good people. I also know a lot of good people in the tobacco industry who want to do the right thing but sometimes don’t always know how. As a small business, it can be tough to understand how to comply with hundreds of pages of dense regulations that grow with each year. As you think about compliance, please don’t assume that everyone is a bad actor and think only about fines and criminal penalties. Compliance should also include processes that help regulated businesses understand errors and deficiencies and give them a chance to correct them and come into compliance before the heavy hand of government comes down on them.

As you think about your next Strategic Plan, if CTP staff would ever like to learn more about cigars, please visit us here in Tampa. Just like wineries, breweries, and distilleries, we have a cigar museum, offer guided factory tours, teach cigar-rolling classes and more as we work to keep the centuries-old tradition of American cigar making alive.

Thank you!”

Drew Newman Testifies Before the U.S. Food and Drug Administration

Drew Newman, fourth generation owner of J.C. Newman Cigar Co., testified before the U.S. Food and Drug Administration at its public hearing on the proposed Tobacco Product Manufacturing Standards (Cigar Aficionado article; Halfwheel article).  From the rolling room at J.C. Newman’s historic El Reloj cigar factory in Tampa, Newman showed how premium cigars are rolled and explained why FDA’s proposed standards won’t work for the small businesses that make up the premium cigar industry.

Prepared Testimony

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:

1. Flexibility is essential
2. It’s a ton a records
3. Qualifying suppliers is difficult
4. Batch reports are hard

1. 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.

2. 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 and work, and cost for small businesses.  We would have to hire new staff to record all of this.

3. 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.

4. 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.

Conclusion

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.