The FDA soon will regulate e-cigarette makers and distributors. The rules present new hurdles for manufacturers of existing e-cigarette products as well as future products. The new “deeming regulations” restrict youth access to e-cigarettes and extend certain regulations that apply to traditional tobacco products to e-cigarettes.

On May 5, 2016, the U.S. Food and Drug Administration announced its regulatory authority over e-cigarettes. Rules aimed at restricting youth access are effective as soon as August 2016. While the announcement did not come as a surprise—the FDA proposed regulations over two years ago—many in the industry argue that the FDA has overstepped its authority.
Continue Reading FDA Extends Regulation of Tobacco Products to E-Cigarettes

On December 8, 2015, researchers at Harvard University announced that they had examined a small sample of flavored e-cigarette products and found that some contained diacetyl, a chemical suspected of causing respiratory illness. In the wake of this announcement, some news organizations reported that the Harvard paper established a “link” between e-cigarettes and bronchiolitis obliterans, a disease associated with diacetyl exposure.

But the Harvard study did not discuss any connection between diacetyl in e-cigarettes and respiratory illness. The researchers merely noted the presence of diacetyl in e-cigarettes and that diacetyl has been associated with respiratory disease in the industrial context. The study drew no conclusions about the possible health risks that vaping poses to consumers. Instead, the study’s authors recommended that this new potential source of exposure to diacetyl be further evaluated.
Continue Reading Researchers Turn Their Attention to Diacetyl in E-Cigarettes

Two partners from Schiff Hardin LLP’s Product Liability & Mass Torts Practice Group spoke about the future of mass tort litigation in the United States at the Lloyd’s Old Library in London on October 20, 2015.  Paul A. Scrudato and Edward Casmere discussed the state of mass tort litigation and its future with a group of London-based insurance professionals in the historic Old Library at Lloyds on Lime Street in London.  The topics included nanotechnology, pharmaceuticals and medical devices, e-cigarettes, wearable technology, and fracking.

Continue Reading Schiff Hardin Partners Present on the Future of Mass Tort Litigation at Lloyd’s Old Library in London

Researchers, academics, public health advocates, and other stakeholders in the e-cigarette industry participated in the FDA’s first public workshop on e-cigarettes over two days in December 2014.  The workshop on e-cigarettes and other vapor products (sometimes referred to as Electronic Nicotine Delivery Systems, or ENDS) suggested that ongoing efforts to regulate these devices are aligning some players while at the same time exposing some divisions within the industry.

Several common themes emerged from tobacco industry representatives, FDA-affiliated presenters, and public health presenters at the workshop: product uniformity, material quality standards, and concerns about user-modified products. Some participants expressed concern that user-modified devices allow for greater inhalation, as well as increased fire risk from more powerful batteries.  FDA chemist Michael Trehy pointed out the presence of impurities in e-cigarettes, as well as variations between claimed and actual nicotine content of certain products.  It was suggested that a push against user-modified products may disadvantage smaller players in the market, who specialize in customizable “open systems,” and that regulations may give large traditional tobacco manufacturers an edge over smaller competitors.


Continue Reading First FDA E-Cigarette Workshop Highlights Divisions in the Industry

E-cigarettes continue to come under fire from numerous groups, as shown by several events in the last week. Scientists from Portland State University, in a January 22 letter to the New England Journal of Medicine, contend that e-cigarette use may carry a risk of cancer 5 to 15 times greater than the risk associated with traditional cigarettes. That conclusion is based on data showing e-cigarette vapers may inhale formaldehyde-releasing agents. The researchers conceded that “[h]ow formaldehyde-releasing agents behave in the respiratory tract is unknown.” However, they estimated a vaper’s daily exposure to formaldehyde could be more than 4.5 times that of a pack-a-day cigarette smoker. This study relates exclusively to e-cigarettes used on high voltage settings – at lower voltages, the scientists detected no formaldehyde.  And the study extrapolated the results from a single test without considering real-world vaping habits, which have not been studied well to date.

Continue Reading Cancer Concerns, Proposed New Regulations Dog E-Cigarette Industry

The Food and Drug Administration (FDA) recently proposed new regulations on electronic cigarettes (“e-cigarettes”), including banning the sale of such products to children under age 18.  But according to more than two dozen state attorneys general, the FDA’s proposed regulations do not go far enough.
Continue Reading Proposed New E-Cigarette Regulations Not Sufficient For More Than Two Dozen State Attorneys General

A mere ten years since their introduction, the “electronic nicotine delivery systems” (ENDS) industry is expected to reach $3 billion by 2015.  As the market for these devices grows, however, so does the potential for tort litigation.  E-cigarettes, “vape pens,” and other ENDS use a heating device to atomize liquid nicotine as well as propylene glycol, glycerin, and flavors.  This allows the user, or “vaper,” to inhale nicotine without the combustion process found in traditional cigarettes. 
Continue Reading As E-Cigarette Market Grows, Regulations and Litigation Risks Multiply