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.
Researcher Dr. Maciej Goniewicz stated that while the risk of ENDS is negligible compared to tobacco, some dangers still exist, including possible contamination. Goniewicz suggested minimizing the risk by using USP-grade solvents and pure nicotine; testing inhalation toxicity of flavors and additives; employing good manufacturing processes; and using inert, airtight, light-resistant containers and sealed packaging to ensure product purity and prevent modification by retailers and users. Representatives of traditional tobacco manufacturers argued that when examining toxicity, researchers must account for impurities and contaminants, claiming that do-it-yourself ENDS products are the real danger, not those supplied by “responsible manufacturers” who strive to ensure quality. They stressed the need to educate product assemblers – especially small manufacturers, and those in China – in the use of safe ingredients and quality control. The significant resources of traditional tobacco manufacturers may offer the advantage of greater control over ingredient quality and manufacturing.
The workshop demonstrated a growing alignment among the regulatory and public health communities and the traditional tobacco industry players on ENDS regulation.
Vaping activists focused on the harm-reduction benefits of ENDS. They encouraged continued research, but cautioned against misconstruing the outcomes to create false fears, arguing that many researchers aren’t familiar with the products and fail to base study protocols on real-world vaping practices. Speakers also addressed the possible public health benefits of ENDS. Sean Gore of the Oklahoma Vapor Advocacy League explained that research demonstrates that ENDS help smokers quit, and do not serve as a “gateway” to smoking. He also asserted that unlike combustible cigarettes, ENDS do not pose a danger of “second-hand” exposure, in part because of the absence of side-stream smoke.
The debate over the health effects of ENDS has escalated over the last few years, as researchers and legislators call for additional studies and caution users about possible risks of long-term use. Some researchers have pointed to the formaldehyde-releasing agents found in the aerosols vapers inhale as potentially posing a greater risk of cancer than traditional cigarettes. A recently published study found impaired lung and immune function in mice exposed to e-cigarette vapor. And numerous state and local governments, in the absence of federal legislation or regulation governing ENDS, have banned sales of ENDS to minors and use of ENDS in public places and called for the FDA to adopt even stricter regulations.
The FDA workshop demonstrated a growing alignment among the regulatory and public health communities and the traditional tobacco industry players on ENDS regulation. Strict standards for ingredient purity, product uniformity, and manufacturing controls could offer a strong competitive advantage to larger, more sophisticated manufacturers over their smaller rivals. Similarly, the push against user-modified ENDS could undercut independent manufacturers who deal in such merchandise, and who sometimes insist that a user’s ability to customize his or her device allows for better harm reduction. Indeed, Dr. Goniewicz acknowledged that “standardization” would primarily impact smaller manufacturers, even suggesting the possibility of a regulatory landscape where only larger companies can effectively bring ENDS products to market.
A further FDA workshop on March 9 and 10 will focus on the impact of e-cigarettes on individual health.