FDA CTP & NIH News

Earlier this week Philip Morris launched a new ad campaign encouraging people to stop smoking and published advertisements in several U.K. newspapers. 
 

CNBC reports that the campaign is called "Hold My Light" and links to a website where smokers can create a profile and have friends commit to help them quit. People who sign up agree to have Philip Morris contact them about its Smoke Free Future program.

This new campaign was not received well by public health groups: 
 

• Cancer Research UK called it "a staggering hypocrisy" and said that Philip Morris is just trying to promote its smoking alternatives, such as heated tobacco. "The best way Philip Morris could help people to stop smoking is to stop making cigarettes," George Butterworth, Cancer Research UK's tobacco policy manager said.
• Action on Smoking and Health also criticized the campaign and said that it was a way for Philip Morris to get around the UK's strong anti-tobacco advertising rules.

BBC article - click here
 

CNBC article - click here
 

A new study, published in Pediatrics, suggests that adolescents who use e-cigarettes are exposed to significant levels of potential carcinogens which are also found in traditional tobacco cigarettes. This finding is true even when the e-cigarettes do not contain nicotine. Researchers frame these findings as a warning to youth that though these devices may be marketed to adults as potentially less harmful than tobacco cigarettes or as cessation aides, e-cigarettes should still be avoided by youth. This peer-reviewed journal article comes from a NIH-funded study with work done by UC San Francisco researchers. 
 

Find the press release from UCSF here: Link
 

Find the full journal article here with currently free full text options: Link
 

Find a Newsweek article about the findings here: Link
 

Find a NBC News article about the findings here: Link
 

The New York Times published an informative article about the new electronic nicotine device called Juul and how it is being used and perceived by American youth. 
 

Read the article here: Link
 

The New York Times reports that a FDA committee has recommended that the FDA reject Philip Morris' proposal that their product IQOS be the first product sold under the FDA's new "modified risk" label. 
 

Though the FDA is not required to follow this recommendation, they usually do and they are expected to make a final decision in the coming months. 
 

Read the article here: Link
 

A new report by the National Academies of Sciences, Engineering and Medicine was released today, January 23, 2018. It is the most comprehensive scientific analysis of all current research on e-cigarettes. The panel concluded that e-cigarettes with nicotine could increase the chance of youth using regular combustible cigarettes, but also that these devices are safer than combustible products and can help smokers quit.

This article can be found here: Link
 

The recently updated US National Institutes of Health clinical trials policies will apply broadly to studies involving experimental manipulations of humans. These studies will require registration and reporting in ClinicalTrials.gov, grant application submission under a clinical trials funding opportunity announcement, and Good Clinical Practice training for investigators.

To read more, please click here.

Since 2009, the United States (US) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacture, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards.

On April 4–5, 2016, FDA/CTP hosted a public workshop focused on biomarkers of potential harm (BOPH) with participants from government, industry, academia, and other organizations. The workshop was divided into five sessions focused on: (1) overview of BOPH; (2) cardiovascular disease (CVD); (3) chronic obstructive pulmonary disease (COPD); (4) cancer; and (5) new areas of research.

The full link to the article can be found here
 

Amy Lukowski (Clinical Director, Health Initiatives Programs at National Jewish Health) writes in the Huffington Post about how tobacco companies are targeting the poor. The article discusses various strategies that tobacco companies use to keep their poorest customers using cigarettes and to get them using cigarettes to being with. Strategies include increased advertising and discounts in poorer neighborhoods. Studies also show that there are more tobacco retailers near schools in poor neighborhoods compared to other neighborhoods. 
 

This article can be found here: Link
 

NPR and The New York Times recently published articles showcasing different perspectives on e-cigarettes. 
 

First, NPR writes about JUUL, a new electronic nicotine device that has become big with teenagers. The article specifically relates this new product to findings from a new Pediatrics article titled "Trajectories of E-Cigarette and Conventional Cigarette Use Among Youth." The journal article shows a connection between youth e-cigarette use and future use of conventional cigarettes. 
 

The New York Times writes about older adult smokers using e-cigarettes to end their use of conventional cigarettes. This is a trend shown by a recent CDC study which found that more people are using e-cigarettes in quit attempts than more conventional methods. Currently there is not "conclusive evidence” that e-cigarettes help long-term cessation, so the government cannot recommend this strategy. However, many tobacco control experts believe that e-cigarettes are a valid form of harm reduction. 
 

• The NPR article can be found here: Link
   
• The Pediatrics journal article can be found here: Link
   
• The New York Times article can be found here: Link
   
• And the CDC journal article can be found here: Link
   

The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies. The agency said it is “re-evaluating and modernizing” its approach to regulating nicotine replacement therapies (NRT), which are typically sold as gums, patches and lozenges. Because their effectiveness is limited, the FDA wants to give consumers a wider range of options.

You can read more about the new measures here.
 

Cigars may have a reputation for being safer than cigarettes, but they may be just as harmful and addictive, according to Penn State researchers who add that small cigars have just as much if not more nicotine than cigarettes.

You can read more regarding the research here.
 

Biomarkers of exposure to new and emerging tobacco delivery products

Accurate and reliable measurements of exposure to tobacco products are essential for identifying and confirming patterns of tobacco product use and for assessing their potential biological effects in both human populations and experimental systems. Due to the introduction of new tobacco-derived products and the development of novel ways to modify and use conventional tobacco products, precise and specific assessments of exposure to tobacco are now more important than ever. Biomarkers that were developed and validated to measure exposure to cigarettes are being evaluated to assess their use for measuring exposure to these new products. The journal article "Biomarkers of exposure to new and emerging tobacco delivery products" reviews current methods for measuring exposure to new and emerging tobacco products, such as electronic cigarettes, little cigars, water pipes, and cigarillos. The journal also discusses the strengths and limitations of current approaches, including whether they provide reliable exposure estimates for new and emerging products. For more information about this study, read the full journal article in the American Journal of Physiology-Lung Cellular and Molecular Physiology.