Posts Tagged With 'Tobacco'

  • Apr
  • 30
  • 2012

FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers

Posted by Marla Scarola In FDA, Regulations, Tobacco, Uncategorized | No Comments »
FDA Study Finds Lower Risk of Lung Cancer Among Menthol Smokers

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.

Posted by Marla Scarola, Senior Consultant. For more information, please contact Marla at marla.scarola@weinberggroup.com.

 

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  • Jan
  • 09
  • 2012

A Rough Road Ahead for Modified Risk Tobacco Products

Posted by Marla Scarola In Regulations, Tobacco, Uncategorized | No Comments »

In the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA was given the authority to oversee the process of approving modified risk tobacco products (MRTP). The law also directed the FDA, in consultation with the Institute of Medicine (IOM), to develop guidance on what types of studies would be needed to support the approval of an MRTP. Recently IOM issued a draft report to the FDA outlining the scientific standards for studies on MRTPs.

It is clear from the draft report that IOM believes that new clinical studies need to be conducted on any tobacco products that are believed to be of reduced harm when compared to cigarettes. Although there is a significant amount of literature available on many products, such as smokeless tobacco and Swedish snus, there is concern that these data and publications may be biased. IOM discusses the dishonest tactics employed by the tobacco industry in the past and, based on this, concludes that the FDA cannot trust new data that the industry generates. Rather, there is substantial discussion of the need for a third party governance entity to conduct clinical studies of MRTPs. The establishment of a third party governance entity will take time and money and a funding source is not clearly defined. Any funding provided by the tobacco industry will need to be carefully distributed in a way that prevents questions of impropriety from being raised.

According to the American Cancer Society, smoking is the most preventable cause of death in our society with tobacco use being responsible for nearly 1 in 5 deaths in the United States. It is a primary goal of the public health community to decrease the number of smokers. There are currently products on the market that have been shown in the published literature to impart less harm than cigarettes and many more products are in development. If adopted, the report from the IOM will make it almost impossible for any tobacco companies to introduce reduced harm products on to the U.S. market in the near future. It is hard to understand how prolonging the amount of time that will pass before MRTPs can be marketed to consumers as safer alternatives to cigarettes is in the best interest of the public health. For those current smokers who are willing but unable to quit, making less harmful products available as soon as possible should be the top priority.

The FDA is due to release its guidance on approval requirements for MRTPs in April 2012. The stance that is taken on the need for a third party governance entity to oversee and generate clinical data will say a lot about the FDA’s view of MRTPs and whether they are willing to work collaboratively with the tobacco industry for the benefit of the public health.

Posted by Marla Scarola, Senior Consultant. For more information, please contact Marla at marla.scarola@weinberggroup.com.

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  • Dec
  • 19
  • 2011

How Will FDA Handle Tobacco Harm Reduction?

Posted by Marla Scarola In FDA, Regulations, Tobacco, Uncategorized | No Comments »
How Will FDA Handle Tobacco Harm Reduction?

Tobacco harm reduction has been a controversial topic for decades. Many on the side of tobacco control argue that any tobacco product is harmful and that all public health efforts should be focused on eliminating the use of tobacco entirely. On the other side of the argument are those that believe trading cigarettes for a less harmful form of tobacco reduces the overall risk of disease or death and that any reduction, even if it comes with continued tobacco use, is beneficial.

Before the approval of various nicotine replacement therapies, products considered as potentially reduced risk included traditional tobacco products such as smokeless tobacco and Swedish snus. Now there are not only a variety of nicotine replacement therapies (e.g. gum, patch, inhaler) on the market, there are also novel nicotine delivery devices available to consumers. So far, nicotine replacement therapies have all been regulated as drugs and have been labeled as smoking cessation aids intended for short-term use only. While it is theoretically possible for these products to obtain labeling as reduced risk products, the exact regulatory pathway for achieving this goal is unclear.

To complicate matters, a recent court ruling determined that novel nicotine delivery devices, specifically electronic cigarettes, are tobacco products rather than drugs. This ruling means that FDA’s Center for Tobacco Products (CTP) now has jurisdiction over these products and potentially all nicotine replacement therapies. CTP has initiated the discussion of what it will take to become a modified risk tobacco product and held a workshop in late August to discuss the regulatory and clinical issues surrounding this designation. However, this path is yet to be taken by anyone and, therefore, there are many unknowns regarding how CTP will handle this type of application.

The world of tobacco harm reduction is changing. There are more products becoming available that may be able to provide current smokers with a less harmful form of tobacco. The FDA should develop a clear path to approval for these products that would allow for long term use and labeling as a reduced harm product. The first sponsor to gain approval of a reduced risk product either via CDER or CTP has the opportunity to have a part in laying the groundwork and setting the bar for future applications.

Posted by Marla Scarola, Senior Consultant. For more information, please contact Marla at marla.scarola@weinberggroup.com.

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