FDA to re-examine premium cigars as it evaluates an overhaul of tobacco regulations
The FDA is taking another look at premium cigars. Anti-tobacco groups are gravely concerned that the agency may weaken regulation.
The rumors are swirling around that the new FDA chief, Scott Gottlieb is taking a serious look at overhauling tobacco and nicotine laws. The agency is seeking feedback on how to define premium cigars and if they pose different risks or are used in different patterns comparted with other tobacco products.
Since 2016, the agency has targeted gradual lowering of the amount of nicotine in cigarettes. In a reversal, the premium cigar industry is hoping that they will ultimately obtain relief.
In a related announcement, the FDA stated that they will be examining the role flavors, including menthol, play in attracting young people to tobacco products. The agency is encouraging them as well as adult smokers to switch to products that are potentially less harmful than cigarettes.
Pfizer’s quit-smoking Chantix treatment fails a safety and effectiveness study in teen smokers
Chantix was approved by FDA in 2006 as a prescription medication which, along with support, helps adults aged 18 and over quit smoking.
Pfizer had committed to post marketing study focused on adolescents aged between 12-16 in the U.S. and 12-17 years of age in Europe.
The study did not meet its goal of the four-week continuous abstinence rate at weeks 9 through 12 for Chantix compared to placebo.
The market for Chantix is estimated to be $1.5B annually. As expected Pfizer stock took a hit.