Science and Law
5th December 2014

E-Cigs are Heating Up! And Science Will Have an Impact on the Legal Landscape

Since entering the U.S. market in 2007, the science related to electronic cigarettes, or e-cigarettes, has been emerging on a number of fronts including their potential health effects, and effectiveness as potential smoking cessation instruments.

E-Cigs are Heating Up! And Science Will Have an Impact on the Legal Landscape

Since entering the U.S. market in 2007, the science related to electronic cigarettes, or e-cigarettes, has been emerging on a number of fronts including their potential health effects, and effectiveness as potential smoking cessation instruments. As a testament to their prominence in mainstream culture, the verb vape (i.e. related to inhaling/exhaling the vapor produced by an e-cigarette) was named as Oxford English Dictionary’s 2014 Word of the Year.

Now, in addition to the emerging science, regulators have been scrambling to understand this new technology. For example, according to the FDA:

“E-cigarettes have not been fully studied, so consumers currently don’t know:

·         the potential risks of e-cigarettes when used as intended,

·         how much nicotine or other potentially harmful chemicals are being inhaled during use, or

·         whether there are any benefits associated with using these products.

Additionally, it is not known whether e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.”

Thus, there are sure to be many questions related to the regulatory, legislative, and legal implications related to these relatively new products. On this note, FDA has issued a proposed rule that would extend its tobacco authority to cover additional products, such as e-cigarettes.

Next week, FDA will be holding an open workshop titled Electronic Cigarettes and the Public Health: A Public Workshop. The objective of the workshop is for FDA to gather scientific information and stimulate discussion among scientists about e-cigarettes, and the “focus of this first workshop will be product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling and environmental impact. Future workshops will address the individual health and population health effects of e-cigarettes.”

Like many other new areas of technology, the science at this point is provocative, sometimes conflicting, and still in its infancy. Further, e-cigs touch upon a number of scientific issues, including their effectiveness as cessation tools, potential toxicity of inhaled constituents, and intellectual property challenges.

One interesting study appeared at the most recent American Heart Association meeting held in Chicago last month. Rahman et al. presented data from their systematic review and meta-analysis of use of electronic cigarettes (e-cigarettes) and smoking cessation. According to the authors, six studies met the inclusion criteria with a total of 1,242 participants (authors did not specify which studies were selected). The six studies included two randomized controlled trials, two cohort studies, and two cross-sectional studies. The results of the meta-analysis indicate that nicotine-filled e-cigarettes were more effective for cessation compared to those without nicotine (pooled RR 2.29, 95% CI 1.05-4.97). Of the more than 1,200 participants, 18% reported complete smoking cessation after using nicotine enriched e-cigarettes for a minimum of 6 months. Interestingly, the authors also reported an association between e-cigarette use (for both those containing nicotine or not) and a reduction in the number of cigarettes consumed by ongoing smokers.

In another recent study, investigators compared nicotine delivery and relative yields of chemical constituents between e-cigarettes and conventional cigarettes. The authors reported that aerosol nicotine for the e-cigarette samples was 85% lower relative to conventional cigarettes, and smoke from conventional cigarettes was found to deliver ~1,500 times more harmful and potentially harmful constituents (HPHCs) compared to e-cigarette aerosol. The authors conclude that these data support the notion that e-cigarettes have a reduced exposure compared to cigarette smoke.

Overall, there remain many outstanding questions related to e-cigarettes, questions that will undoubtedly have a dramatic impact on regulations, legislation, and ultimately litigation. The litigation that will undoubtedly emerge will be complex and multi-faceted. Likely allegations may include the following: challenges to effectiveness; toxicology of the inhaled constituents; potential adverse health events; physical hazards of the products; intellectual property challenges; and uniform manufacturing and/or consistent dose delivery of the products’ active ingredients.

 

The scientific consultants at Innovative Science Solutions are uniquely suited to help you navigate this complex landscape as it pertains to litigation issues as they emerge.

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