Drew Newman Testifies Before FDA About Its New Strategic Plan

He encouraged the agency to remember the continuum of risk, that we are an industry of small businesses, and that FDA should help businesses not just penalize them.

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.
 

      1. 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.
 

      1. 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 to fda