Should e-cigarette regulation be stricter?

Need for stricter e-cigarette regulation

At the June 2014 American Medical Association Annual Meeting (AMA) in Chicago, the AMA adopted a policy opposing the sales and marketing of electronic cigarettes (e-cigarettes) and nicotine delivery products to minors.

electronic cigarettes and the AMA

This policy extends one that was adopted in 2010 and discussed in the May, 2013 scienceandyourhealth.com blog entry , that calls for all e-cigarettes to be subject to the same regulations and oversight that the U.S. Food and Drug Administration (FDA) applies to tobacco and nicotine products.

In 2010, the AMA Council on Science and Public Health (CSAPH) reviewed AMA Policy related to e-cigarettes, the manufacture and characteristics of e-cigarettes, current regulations and the potential health impacts of these products, and their potential role in smoking cessation.

The newly adopted AMA policy also supports product requirements for e-cigarettes and nicotine delivery systems, including: disclosures regarding design, content and emissions; child-proof and tamper-proof packaging and design; enhanced product labeling; restrictions related to flavors that appeal to minors; and, prohibition of unsupported marketing claims as a tobacco cessation tool.

Although e-cigarettes have been marketed as smoking cessation aids, there is no conclusive scientific evidence that e-cigarettes promote successful long-term quitting. According to a new UC San Francisco study, e-cigarettes, promoted as a way to quit regular cigarettes, may actually be a new route to conventional smoking and nicotine addiction for teenagers. Researchers found that e-cigarettes were associated with more, not less, cigarette smoking among adolescents.

And recently, the Center for Disease Control and Prevention has reported that use of e-cigarettes by students in U.S. middle schools and high schools more than doubled from 3.3 percent in 2011 to 6.8 percent in 2012.

The AMA policy supports an FDA proposal to fill the gap in federal regulations on purchasing, labeling, packaging and advertising of electronic cigarettes. The proposed FDA regulation is an important step to improve public health and deter the sale of electronic cigarettes to minors.

Houston Facial Plastic Surgeon, Russell Kridel, MD, is currently a member of the AMA Board of Trustees and the immediate past chair of the AMA Council on Science and Public Health.

Any views expressed on this blog should be considered personal views of Dr. Kridel and are not official statements of AMA policy (which is set by the AMA House of Delegates) nor are they official descriptions of actions of the AMA Board of Trustees.

 

Do e-cigarettes help people quit smoking?

Electronic cigarettes, known as E-cigarettes, are not comparable to FDA-approved nicotine-delivery devices that have been shown to help people quit smoking. At this time, their dosage, manufacture, and ingredients are not consistent and the products are not clearly labeled, thus making their use by smokers wanting to quit an uninformed proposition.

More importantly, the manufacturers of e-cigarettes have not submitted the requisite applications for FDA approval of these products for smoking cessation. Only one small clinical trial, funded by an e-cigarette manufacturer has been published on their efficacy as a smoking substitute (but not as a cessation aid). The FDA has rejected claims by e-cigarette makers and distributors that their devices are safer than real cigarettes and mitigate the harm of smoking. While some distributors have implied that their products help people quit smoking tobacco products, the FDA views them as unapproved synthetic nicotine delivery devices with unknown safety and efficacy.

In 2008, the World Health Organization (WHO) noted that, “Contrary to what some marketers of the electronic cigarette imply in their advertisements, the WHO does not consider it to be a legitimate therapy for smokers trying to quit. WHO knows of no evidentiary basis for the marketers’ claim that the electronic cigarette helps people quit smoking. Indeed, as far as WHO is aware, no rigorous peer-reviewed studies have been conducted showing the electronic cigarette is a safe effective nicotine replacement therapy.”

Whether e-cigarettes can safely help people quit smoking also is unknown, but with their fruit and candy flavors, they have a clear potential to entice new smokers, especially teens. In addition, because of the unregulated dosing of nicotine, they clearly can be addictive. It is evident from what little information we have that the concentration levels of the nicotine and other compounds are variable, and that there are toxins and carcinogens present. Thus, controlled trials and test market studies are needed to determine if they are safe and effective as a smoking cessation device as is being reported in the media and on the manufacturers’ Web sites.

Similar to concerns regarding the manufacture and sale of tobacco products, the actual content, performance as a nicotine delivery device, safety, and purity of e-cigarettes is largely unknown. Due to the lack of rigorous chemical and animal studies, as well as clinical trials on commercially available e-cigarettes, neither their value as therapeutic aids for smoking cessation nor their “safety” as cigarette replacements is established and remains speculative.

Read the AMA Council on Science and Public Health Report on “Use of Electronic Cigarettes in Smoking Cessation.” http://www.ama-assn.org/resources/doc/csaph/a10csaph6ft.pdf

Russell W.H. Kridel, M.D.

What are e-cigarettes?

Electronic cigarettes, known as E-cigarettes, are non-flammable devices that deliver synthetic or tobacco-derived nicotine; they are similar in size, shape, and usage to their leaf tobacco counterparts. They are available worldwide through the Internet or increasingly in retail outlets.

However, due to the lack of rigorous chemical and animal studies, as well as clinical trials on commercially available e-cigarettes, neither their value as therapeutic aids for smoking cessation nor their  “safety” as cigarette replacements is established and remains speculative.

E-cigarettes consist of three integrated parts contained in a stainless steel shell: the mouthpiece (or nicotine cartridge), the atomizer chamber (or  vaporizer), and a smart chip lithium ion battery.  Typically, a disposable filter holds a cartridge containing synthetic nicotine dissolved in propylene glycol, water, and flavorings.

When the entire unit is assembled, the user creates an inhaling motion which activates the battery via pressure sensors. The battery powers the vaporizer, and the vaporizer heats the liquid housed in the mouthpiece. As such, the electronic cigarette is a delivery device for the addictive substance nicotine. The vapor released is polyethylene glycol (PG), which looks like cigarette smoke (also used for theatrical smoke) and is also an FDA-approved food additive. The volume released varies by brand, but when inhaled feels like cigarette smoke to users. Unlike tobacco smoke, the vapor quickly evaporates, leaves no remaining odor, but the secondhand smoke may still be irritating.  Compared with conventional cigarettes, which last for about fifteen puffs, e-cigarettes can sustain 150 to 300 puffs, the equivalent of one-half to one pack of cigarettes. The cartridges vary in nicotine strength, being characterized as “zero,” low, medium, or high. Disposable, non-refillable versions, equivalent to one or two packs of cigarettes, also are available.

In tests conducted by the FDA’s Division of Pharmaceutical Analysis on two brands of e-cigarettes, additional ingredients were detected including diethylene glycol in one cartridge (a component of antifreeze and toxic to humans) and tobacco-specific nitrosamines (a known carcinogen) in half of the samples. This is very concerning and adds to the premise that such items should be closely regulated.

E-cigarettes were invented by an employee (Hon Lik) of a Chinese electronics company (Ruyan) headquartered in Beijing, which began marketing e-cigarettes in 2004. The Ruyan Group remains the leading manufacturer of e-cigarettes (sold as Ruyan® e-cigarettes), but additional manufacturers using similar devices have subsequently entered the market, offering their products worldwide via the Internet, in shopping malls, and other distributors. Prices for the devices (a charger, rechargeable battery, and five nicotine cartridges) range from about $80 to $150 with packages of replaceable cartridges, each good for several uses, costing $10 to $15 or the equivalent of 1 to 1.5 packs of cigarettes.

Per the CSAPH report, manufacturers of e-cigarettes have not submitted the requisite applications for FDA approval of these products for smoking cessation. And the Food and Drug Administration (FDA) has warned the public against e-cigarettes, saying they cannot be considered legitimate therapy for smokers to quit and that they could turn children into smokers.

Questions answered by Russell W.H. Kridel, M.D. as a public service to patients concerned about current health issues. All of the facts are gathered from published reports of AMA Council on Science and Public Health and approved by the AMA House of Delegates.

Read the AMA Council on Science and Public Health Report on “Use of Electronic Cigarettes in Smoking Cessation.”

Russell W.H. Kridel, M.D.