Senator Marco Rubio Chairs Senate Hearing on FDA Regulation of Cigars

On April 5th, 2019, the United States (U.S.) Senate Committee on Small Business and Entrepreneurship held a hearing in Ybor City, Tampa, FL, entitled “Keep Small Premium Cigar Businesses Rolling.” Senator Marco Rubio (R-FL) chaired the hearing which focused on the Federal Drug Administration’s (FDA) regulation of cigars.

The hearing included a panel of business, cigar, and medical experts. The witnesses were:

• Mr. Charles Maresca, Director of Interagency Affairs, Office of Advocacy, U.S. Small Business Administration,
• Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research, University of Lousville, KT,
• Mr. Jeff Borysiewicz, President and Founder, Corona Cigar Company,
• Mr. Drew Newman, General Counsel and Great-Grandson of the Founder, J.C. Newman Cigar Company.

As a refresher, in April, 2014, the FDA issued a proposed rule (aka the “Deeming Rule”) that deems formerly unregulated and uncovered products such as premium cigars subject to FDA regulation. These requirements include pre-market authorization, health warnings, and sales restrictions. Since this time, Cigar Rights of America, cigar manufacturers, cigar retailers, and cigar smoking citizens have fought to convince the FDA to exclude premium cigars from the Deeming Rule.

The following highlights key takeaways from the hearing.

1. The Office of Advocacy at the U.S. Small Business Adminstration has submitted three letters to the FDA objecting to the regulation of cigars. The Office of Advocacy takes issue with the FDA’s statutory requirement to implement the requirements of the Regulatory Flexibility Act (RFA) requiring federal agencies to consider the effects of their proposed rules on small businesses. Specifically, the FDA did not describe the impacts on small businesses affected by the new regulation nor explained significant alternatives that might reduce this impacts in the FDA’s new regulations. To date, the FDA has ignored the Office of Advocacy letters and pressed on with their regulation. Bottom Line: The FDA doesn’t give a hoot about small business cigar manufacturers or cigar shops.
2. The FDA estimates compliance with the new regulations to cost up to $397,000 the first year, $411,000 in the second year, and $257,000 the third year. The median annual revenue for cigar manufacturers in the U.S. is $252,800. As an example, the estimated total cost for J.C. Newman’s historic Tampa cigar factory to comply is more than $30 million, more than three times the annual gross sales from its Tampa cigar factory. Bottom Line: The vast majority of premium cigar manufacturers in the U.S. cannot afford to comply with the FDA regulations and will be forced to go out of business.
3. According to an FDA study, smoking up to two cigars a day does not significantly increase the risk of death from smoking-related cancers, coronary heart disease, stroke, or emphysema. According to Dr. Rodu, “With low prevalence and minimal to no adverse health effects, regulation of cigars will have negligible impact on public health.” Bottom Line: The FDA doesn’t care what their own study says. They want all forms of tobacco eliminated from the U.S.
4. In 2009, Congress gave FDA authority to regulate tobacco products to address “youth usage and addictiveness”. However, FDA’s own research has shown that children do not smoke premium cigars and the typical consumer smokes 1.7 premium cigars per month. Bottom Line: Teens don’t smoke premium cigars and even if they did, premium cigars are not addictive.
5. An article written by FDA staff, funded by the FDA, and published in Oxford University Press’s Nicotine and Tobacco Research found that the median age of “first regular use” for “premium cigars” is 24.5 years. Bottom Line: Teens still don’t smoke cigars!

You can listen to the entire hearing HERE.

Here’s the written testimony of each of the panel members:

• Charles Maresca
• Brad Rodu
• Jeff Borysiewicz
• Drew Newman

Final Thoughts: The panel outlined the facts surrounding teen usage of cigars, the costs associated with compliance, and the medical risks of smoking cigars. Although the FDA doesn’t want to hear it, there is no logical reason for the FDA to regulate premium cigars. C’mon FDA, these are not the droids you are looking for!