Dr. Gaby Kafie, owner and founder of Kafie 1901 Cigars, has authored a letter to U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb in regards to nicotine levels in cigars.

The letter is a response to the recent Advanced Notice of Public Rule Making (ANPRM) in terms of maximum nicotine levels. In the ANPRM, the FDA specifically asks for examples and proof on whether premium cigars should be exempt or treated differently from other tobacco products such as cigarettes.

Kafie’s goal was to educate and provide concrete examples of why cigars are a poor delivery method of nicotine and thus non-addictive. We have shared his letter verbatim.

(Letter Verbatim from Dr. Kafie, re-printed with permission)

RE: Premium Cigars are a poor nicotine delivery method, and thus are non-addictive

Dear Dr. Gottlieb,

My name is Dr. Gaby Kafie, I am a retired physician (with a clear and active U.S. medical license from the State of Florida) and owner of a premium boutique cigar factory in Danli, Honduras. I am writing you this letter to urge you to reconsider FDA regulations on premium cigars. I believe personally and professionally that premium cigars should be exempt from FDA regulations/oversight.

For over 5 years I have enjoyed producing premium cigars along with my entire team in Honduras. Premium cigars are not only a passion of mine, but also our family business. Our business employs over 90 people in Honduras, and impacts nearly 650+ brick and mortar tobacconists (retailers) here in the United States. These tobacconists depend on our products in order to operate their own family businesses. The FDA and its current over-reaching regulations on premium cigars have put our livelihood at risk. We are deeply concerned about our future, as well as the future of the premium cigar industry.

Premium cigars are enjoyed only by adults. They are sold in large part only in licensed brick and mortar cigar shops. These establishments are not frequented by young, or underaged people. It’s a select adult clientele that visit these businesses.

Recently I have taken a deep interest in premium cigars as a “delivery method” for nicotine. As a Premedical Student I excelled in Chemistry, Organic Chemistry and Biology, and while in Medical School I studied pharmacology and human physiology as part of our core medical studies. My opinions are measured and thorough and have the full support of the attached literature.

It is known throughout the premium cigar industry (cigar factories) that our tobacco products do not cause addiction. Addiction is directly related to nicotine levels absorbed in the process of smoking. Unlike cigarettes, the tobacco used in premium cigars is fermented for long durations of time (6 – 18 months or longer). The fermentation process is done to specifically remove ammonia from the tobacco. This removal of ammonia from the tobacco reduces nicotine absorption by cigars connoisseurs.

I have always had certain beliefs about premium cigars, tobacco, ammonia, and nicotine absorption and efficacy in humans. I have always known that premium cigars are a poor nicotine delivery method to humans.

The attached abstracts clearly discusses the chemistry behind nicotine and ammonia levels in tobacco products. The tobacco used in cigars is fermented (always), the purpose of this fermentation process (an exothermic reaction) and aging is to eliminate as much ammonia as possible from the tobacco, in order to bring out the natural appealing flavors of the tobacco.

Tobacco fermentation in essence reduces the pH of the tobacco from an alkaline state (pH 9.4) to a more neutral pH (pH 7) or lower. The resulting standard low level of ammonia in premium cigar tobacco results in non-volatile nicotine salts which are not absorbed by the human body. Furthermore, since premium cigar smoke is not intended to be inhaled, absorption of nicotine is even lower.

On the other spectrum, cigarette companies purposely process their tobacco quickly (without fermenting it in order to preserve the ammonia), and even add more ammonia to cigarette tobacco to convert the nicotine salts to a more volatile free base that is more readily absorbed in the airways. A cigarette is designed to be the ideal nicotine delivery method, in an effort to cause addiction.

Ultimately, I repeat … premium cigar smoke is not inhaled, whereas cigarette smoke is. I know you understand the dangers of cigarette smoking and it is for this reason that you stated the following… “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users”, said FDA Commissioner Scott Gottlieb, M.D.

I always tell people premium cigars are non-addictive, because the chemistry of the tobacco proves it to be non-addictive. Premium cigars are enjoyed by adults as a hobby, on occasion, socially or privately as a form of relaxation and meditation. The paragraph below was taken from the attached abstract.

To the contrary, the cigarette industry does the following (in order to create addiction)…

“Annually, about five million kilos of ammonia are used in the manufacture of US cigarettes, an amount that corresponds to 10 mg of ammonia per cigarette produced [ID (Johnson, 1989) ]. In addition to ammonia various ammonia salts and urea are commonly used as tobacco additives in the cigarette manufacture (usually max. 5% w/ w) serving as a source of ammonia.” (Food and Chemical Toxicology Volume 44, Issue 5, May 2006 pages 678-688 RE: Section 3.3)

It’s time we stop and look at the premium cigar industry and the role it plays in tobacco addiction and nicotine delivery. Understanding the fermentation process which is characteristic of the premium cigar industry will help you realize that premium cigars are a poor nicotine delivery method. I am in agreement with the FDA that cigarette smoking causes addiction, in large part because cigarettes are designed to be the ideal nicotine delivery instrument.

I have gone ahead and attached the scientific journals that were referenced to write this piece. I hope you will take the time to review the materials.

Thank you for your time to read my short letter. I ask you once again to please reconsider the FDA’s stance on premium cigars. Family businesses across America will be devastated due to these over-reaching regulations, mine being one of them.

Urge the FDA to reconsider exempting premium cigars from tobacco regulations. Such regulations will put us out of business. Premium cigars are not the problem, it just so happens that because the word “tobacco” is in play, we have gotten caught up in the whole FDA regulation of tobacco products. One must clearly take the time to understand the process of how premium cigars are made in order to realize that they are not a threat to people who enjoy them.

I hope that this letter will help clarify my point, that premium cigars are a poor nicotine delivery method, and thus non habit forming.

Kind regards,

Dr. Gaby Kafie
Kafie Trading Company, LLC

Reference: Food and Chemical Toxicology Volume 44, Issue 5: Significance of ammonium compounds on nicotine exposure to cigarette smokers

Reference: Nicotine Chemistry, Metabolism, Kinetics and Biomarkers

Kafie told Cigar Coop he is currently working with Cigar Rights of America to utilize the letter and plans a response to ANPRMs. It is important to note this is a concrete example of the type of feedback the FDA is looking for on the ANPRMs that have recently been issued.