An Open Letter to Newly Named FDA Commissioner Scott Gottlieb
Jun 20, 2017
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[This Blog first appeared as an Editors' Note in the July/August 2017 Cigar Aficionado.]
Congratulations on your May 9, 2017 appointment as FDA commissioner. You step into this role at a crucial time.
I am writing you on behalf of a small, artisanal industry—the handmade cigar industry—which has a proud heritage dating back more than 200 years. It is composed primarily of small and medium-sized businesses, many of them family owned.
They fear extinction. Not from market factors, nor from consumers rejecting their products, but from their own government. The Obama Administration moved control of the cigar industry to the FDA, and after years of threats and uncertainty the FDA has shackled the cigar industry with a great number of unmanageable operational restrictions, not the least of which is severely limiting the introduction of new products. Even more restrictions are scheduled to follow in the coming months. All of these prohibitions are starting to strangle the industry.
Millions of Americans smoke handmade cigars. Firefighters. Policemen. Lawyers. Doctors. Professors. Congressmen. Judges. Members of our military. Friends of yours and friends of mine. Adults from all walks of life. Working Americans who every day contribute to our society and our economy.
While President Trump has voiced his outrage at overregulation in the United States, and has taken on deregulation as a major policy initiative, the cigar companies who represent this great industry find themselves in dire need of relief.
More than $3 billion was spent on lobbying last year alone in the United States, according to the Center for Responsive Politics. Look at the spending by sector: the pharmaceutical industry alone spent $246 million on lobbying last year. The insurance industry spent $147 million, oil and gas spent $119 million, and the auto industry $62 million.
The small, handmade cigar industry doesn't have that type of financial strength. As a result, it's being swept under the carpet, lumped into the far-larger cigarette and machine-made cigar industries, which it has nothing to do with and wants nothing to do with. The handmade cigar industry has had little say in its own affairs.
In order to comply with the FDA's new restrictions, cigar companies are facing the prospect of enormous new costs—hundreds of thousands of dollars per company—that are onerous, burdensome and most of all unnecessary.
A new study, partially funded by the FDA—yes, your FDA—and published on January 26 in The New England Journal of Medicine, documented that premium cigars are not being smoked by the youth of America. The two-year study looked at the behavior of more than 45,000 people, including 13,651 youths, and found that the number of youths who frequently or regularly smoke handmade cigars was less than one percent—statistically irrelevant. Handmade cigars are enjoyed by adults, period.
We need your help. If left unchecked, these new FDA regulations will destroy the handmade cigar industry, and the tens of thousands of American jobs it supports.
The families who work in this industry are not looking for special treatment. They only ask for just and fair treatment. The right to sell a legal, handmade product to consenting adults. The right to pursue the American dream.
I ask you to please look into these unfair and unjust restrictions the FDA is forcing down the throat of this proud and venerable industry.
My best,
Marvin R. Shanken
Editor & Publisher
CC: President Donald Trump
CC: Vice President Mike Pence
URGENT ALERT: WRITE THE FDA
Dear Dr. Gottlieb,
Congratulations on your May 9, 2017 appointment as FDA commissioner. You step into this role at a crucial time.
I am writing you on behalf of a small, artisanal industry—the handmade cigar industry—which has a proud heritage dating back more than 200 years. It is composed primarily of small and medium-sized businesses, many of them family owned.
They fear extinction. Not from market factors, nor from consumers rejecting their products, but from their own government. The Obama Administration moved control of the cigar industry to the FDA, and after years of threats and uncertainty the FDA has shackled the cigar industry with a great number of unmanageable operational restrictions, not the least of which is severely limiting the introduction of new products. Even more restrictions are scheduled to follow in the coming months. All of these prohibitions are starting to strangle the industry.
Millions of Americans smoke handmade cigars. Firefighters. Policemen. Lawyers. Doctors. Professors. Congressmen. Judges. Members of our military. Friends of yours and friends of mine. Adults from all walks of life. Working Americans who every day contribute to our society and our economy.
While President Trump has voiced his outrage at overregulation in the United States, and has taken on deregulation as a major policy initiative, the cigar companies who represent this great industry find themselves in dire need of relief.
More than $3 billion was spent on lobbying last year alone in the United States, according to the Center for Responsive Politics. Look at the spending by sector: the pharmaceutical industry alone spent $246 million on lobbying last year. The insurance industry spent $147 million, oil and gas spent $119 million, and the auto industry $62 million.
The small, handmade cigar industry doesn't have that type of financial strength. As a result, it's being swept under the carpet, lumped into the far-larger cigarette and machine-made cigar industries, which it has nothing to do with and wants nothing to do with. The handmade cigar industry has had little say in its own affairs.
In order to comply with the FDA's new restrictions, cigar companies are facing the prospect of enormous new costs—hundreds of thousands of dollars per company—that are onerous, burdensome and most of all unnecessary.
A new study, partially funded by the FDA—yes, your FDA—and published on January 26 in The New England Journal of Medicine, documented that premium cigars are not being smoked by the youth of America. The two-year study looked at the behavior of more than 45,000 people, including 13,651 youths, and found that the number of youths who frequently or regularly smoke handmade cigars was less than one percent—statistically irrelevant. Handmade cigars are enjoyed by adults, period.
We need your help. If left unchecked, these new FDA regulations will destroy the handmade cigar industry, and the tens of thousands of American jobs it supports.
The families who work in this industry are not looking for special treatment. They only ask for just and fair treatment. The right to sell a legal, handmade product to consenting adults. The right to pursue the American dream.
I ask you to please look into these unfair and unjust restrictions the FDA is forcing down the throat of this proud and venerable industry.
My best,
Marvin R. Shanken
Editor & Publisher
CC: President Donald Trump
CC: Vice President Mike Pence
URGENT ALERT: WRITE THE FDA
archived comments
"He didn't say Obama was responsible he said it happened during the Obama Administration. You can try and say this isn't a political issue but that would be narrow minded at best. This is political at the core. Government trying to regulate us to the greatest degree possible. They have tried and tried and when taking away the rights of law abiding adults and it has never ended well. These laws will simply allow the biggest of the companies prosper and put all of the small shops out of business. There will be no new cigar manufacturers, no new brands of cigars. We need government to stop trying to include hand made cigars in with cigarettes. " —July 9, 2017 16:27 PM
"The Obama administration didn't move control of the cigar industry to the FDA, Congress gave them jurisdiction to regulate tobacco (the Family Smoking Prevention and Tobacco Control Act), which the FDA decided included premium cigars. Blaming Obama for everything is such useless, right-wing garbage that stops any hope for an intelligent dialogue in its tracks. The same garbage that got our psychopath president elected, who, by the way, is rolling back the progress the Obama administration DID make with Cuba, but where is your "open letter" to him? There is a good LEGAL argument to be made that premium cigars should be exempted from the FDA's regulation, let's not POLITICIZE it. If you want to politicize it, why don't you talk about how pulling out of the Paris climate deal is going to contribute to global warming, and the devastation that will render on growing tobacco?" —June 25, 2017 21:14 PM
