FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers

April 30, 2012

In March 2011, the Tobacco Products Scientific Advisory Committee released a report on the impact of menthol on public health.  Based on the committee’s review of all available evidence, they recommended the ban of menthol.  Following the release of TPSAC’s report, the FDA began a thorough review of their findings and also considered a report on the issue prepared by the tobacco industry.  Stakeholders continue to await the FDA’s final determination and it is unclear when this information will be available.

In the report, TPSAC concluded that the evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco‐caused diseases than smokers of non‐menthol cigarettes, but did note that epidemiologic data do not demonstrate increased disease risk in people.  Adding to this body of evidence is a study recently released by a scientist from FDA’s Center for Tobacco Products. The study used 20 years of data from the large nationally representative household health survey, the National Health Interview Survey (NHIS).  Included in the analysis were 6,074 smokers, including 1,417 who smoked only menthol cigarettes.  Not only did the author report no difference in lung cancer mortality or all cause mortality between all menthol smokers and nonmenthol smokers, menthol smokers at ages 50 and over had a lower risk of lung cancer mortality compared with nonmenthol smokers.

This latest FDA study adds to a growing body of evidence that suggests modest to statistically significant reduced risks for lung cancer among menthol smokers.  In the face of a potentially lower risk of lung cancer associated with menthol cigarettes, it will be even more difficult for the FDA to ban them from the market.

If you have any questions or thoughts on this blog post or others, please contact us.

TAGS:

Person working on laptop and desktop devices

What is a Clinical Evaluation Report (CER)?

If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term 'CER' or Clinical...

Medical Device Regulation in the EU in the Midst of the COVID-19 Pandemic

Background: Medical Device Regulation in the EU Unlike device regulation in the U.S., which is governed by the FDA, in Europe, medical devices are not regulated by the EMA. Rather, medical device...

Changes in Medical Device Regulatory Requirements in Europe (2021)

In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...