Science and Law
30th November 2015

Keeping your Finger on the E-Cigarette Science Pulse

The Center for Environmental Health (CEH) filed lawsuits against multiple companies for failing to warn consumers that e-cigarettes contain nicotine, and in some instances formaldehyde and acetaldehyde. These lawsuits appear to be based on California’s Prop 65 consumer protection law.

Keeping your Finger on the E-Cigarette Science Pulse

Regulatory and legal activity related to e-cigarettes is heating up.

The Center for Environmental Health (CEH) filed lawsuits against multiple companies for failing to warn consumers that e-cigarettes contain nicotine, and in some instances formaldehyde and acetaldehyde. These lawsuits appear to be based on California’s Prop 65 consumer protection law. Briefly, CEH commissioned an accredited and independent laboratory to test 97 e-cigarettes for levels of formaldehyde and acetaldehyde. According to CEH, the laboratory results demonstrate that 90% of the companies produced at least one e-cigarette that emitted “high” levels of formaldehyde and/or acetaldehyde. The CEH notes that one e-cigarette was found to emit 470 times the California safety standard for formaldehyde.

As we’ve noted previously (see here and here), the science related to e-cigs is moving very quickly, and is likely to continue on this trajectory as the debate around the potential toxicity of e-cigs, as well as their effectiveness as smoking cessation tools, remains unclear.

Now more than ever, it is critical for manufacturers and attorneys representing e-cigarettes clients to stay up-to-date on current science related to e-cigarettes. By keeping your finger on the e-cigarette science pulse, you can avoid being ambushed by new science, and also evaluate the potential implications of new scientific findings.

Below we provide a brief description of some very recently reported scientific findings on e-cigarettes in the following areas: potential toxicity, efficacy, and regulatory activity. As you can see, some of findings are helpful to e-cigarette manufacturers, while other studies may highlight real or potential sources of concerns.

Potential Toxicity Related to E-Cigs

Particulate Matter from Electronic Cigarettes and Conventional Cigarettes: a Systematic Review and Observational Study.

This was a systemic review of the literature coupled with an observational study. The authors identified and reviewed eight studies on the composition of aerosols from e-cigarettes originated by human vaping. They report that that emissions from e-cigarettes can contain potential toxic compounds such as carbonyls, metals, organic volatile compounds, and particulate matter (PM). In the observational portion of the study, the PM2.5 median concentration was 9.88 μg/m(3) in the e-cigarette user home compared to 9.53 and 9.36 μg/m(3) in the smoke-free homes, with PM2.5 peaks concurrent with the e-cigarette puffs. 

Has the mist been peered through? Revisiting the building blocks of human health risk assessment for electronic cigarette use 

Another literature review concluded that e-cigarettes emit less toxins and carcinogens compared to traditional cigarettes. However, the authors note that “e-vapor is not safe and could adversely affect human immune functions.” Additionally, the authors suggest that further studies need to be conducted to close the knowledge gaps that still exist. They define these gaps as lack of long-term data, lack of understanding the mechanism behind the exposure to e-cigarettes, and lack of integration between exposure and toxicity assessments. 

Efficacy of E-cigarettes as Tools for Smoking Cessation 

Electronic cigarettes: assessing the efficacy and the adverse effects through a systematic review of published studies. 

In this systematic review of the literature related to the efficacy of e-cigarettes as smoking cessation tools, the authors reported that when cigarettes are replaced with e-cigarettes, the total number of cigarettes smoked decreased, and individuals also experienced a reduction in withdrawal symptoms. In the studies evaluated in this report, the most frequently reported adverse events included ‘mouth and throat irritation’, ‘nausea’, ‘headache’ and ‘dry cough.’ Notably, the authors caution that long-term studies are needed to evaluate the effects of the e-cigarettes usage after a chronic exposure.

Status of FDA E-Cig Regulations

FDA has sent its proposed final rule to regulate additional tobacco products, including electronic cigarettes and cigars, for White House review.

As you are likely aware, FDA has proposed to extend its authority to cover additional products that meet the definition of a tobacco product under the proposed rule: Tobacco Products Deemed To Be Subject to the Food, Drug & Cosmetic Act (Deeming). Currently FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, and others.

This is significant, since the new proposed regulations may put many small e-cig companies out of business due to regulatory requirements that would be prohibitively costly.

According to FDA, the rule in draft form was submitted to the Office of Management and Budget (OBM) on October 15, 2015 for review. Notably, FDA recently put out a statement to notify the public that FDA had not yet issued its final rule related to this issue, despite the fact that the Tobacco Vapor Electronic Cigarette Association (TVECA) indicated publicly that it has a copy of the draft final rule. Overall, it seems that we will continue to have to wait for the release of the final rule.

The science related to e-cigs is moving quickly, and more than ever, it is important for manufacturers and their attorneys to be up-to-date on the latest findings. This will allow you to assess the implications of new findings, and reduce the risk of being ambushed by new findings.

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