Nicotine Vapor Now Regulated with Tobacco

Written by Geoff Kane, MD, MPH. Posted on

Efforts to create electronic cigarettes date from the 1930s. The first commercially successful devices were produced in China in 2003. Electronic cigarettes were introduced to Europe in 2006 and America in 2007. In the United States, regulation of these and similar products became much more stringent in 2016.

The Family Smoking Prevention and Tobacco Control Act became law June 22, 2009, and gave the U. S. Food and Drug Administration (FDA) regulatory authority over the manufacture, distribution, and marketing of tobacco products. The FDA has deemed electronic nicotine delivery systems (ENDS) to be tobacco products and issued regulations that affect not only electronic cigarettes (e-cigarettes) but also other devices that produce an inhalable cloud containing atomized nicotine. Initial stipulations took effect August 8, 2016. Additional requirements are scheduled for 2018.

Some ENDS resemble conventional means for smoking tobacco, such as e-cigarettes, e-cigars, electronic pipes, and electronic waterpipes. There are also hand-held personal vaporizers that look like oversized pens or electronic boxes with high-tech tubes on one end. Usual components of these devices include a cartridge or reservoir (“tank”) to hold a solution containing nicotine, the solution itself (e-liquid or “juice”), a heating coil to vaporize the solution, a wicking mechanism to bring solution to the coil, a battery to power the coil, and a mechanism to turn the power on and off. The user briefly activates the unit and inhales nicotine-containing vapor as it is generated.

Most e-liquids contain nicotine extracted from tobacco. Synthetic nicotine is sometimes used, but it’s more expensive and unlikely to avoid FDA regulation despite not being a tobacco product. E-liquids listing no nicotine content are still subject to regulation.

E-liquids are manufactured with a range of nicotine concentrations to accommodate different consumer preferences and methods of use. A light-to-moderate strength e-liquid, for example, contains 6 milligrams of nicotine per milliliter of solution. The bulk of e-liquids (80 to 90 percent or more) are either propylene glycol (PG), vegetable glycerine (VG), or a blend of the two. The rest is nicotine, flavoring, and perhaps added distilled water. PG and VG are common food additives considered safe for humans to eat. Their safety when inhaled has not been established.

Overall, this technology and the growing consumption of nicotine-containing vapor are so new that there is no way to know their long-term effects on the health of users or bystanders. In 2014, “vape”—meaning “to inhale and exhale the vapour produced by an electronic cigarette or similar device”—was the Oxford Dictionaries (new) Word of the Year.

Despite being new and unproven, vaping intrigues many individuals addicted to tobacco products, particularly cigarette smokers. Might it allow them to wean off nicotine, safe from the toxic chemicals in tobacco smoke and without entirely giving up rituals of smoking? Expert opinion is mixed and regional.

In the United Kingdom, the Royal College of Physicians urged smokers to switch to e-cigarettes after concluding the potential benefit outweighs the potential harm. In the United States, on the other hand, authorities such as the Centers for Disease Control and Prevention, the American Lung Association, the American Thoracic Society, and the American College of Chest Physicians emphasize the addictive power of nicotine and the lack of evidence regarding the safety of ENDS. They advocate restricting access or banning these devices until more is known. Some countries including Argentina, Mexico, and Thailand do ban e-cigarettes; others such as Denmark, Hungary, and New Zealand allow them only if the solution does not contain nicotine. The United Kingdom, Germany, the Netherlands, and others have no restrictions.

U.S. experts direct smokers who want to quit to methods supported by research, such as nicotine replacement with patches and gum, bupropion (Zyban, Wellbutrin), and varenicline (Chantix). As of August, the FDA restricts manufacturers and retailers of ENDS from saying their products are “safe and effective” for quitting smoking until science backs that up. The World Health Organization took the same stance in 2008.

Local laws creating smoke free areas such as restaurants and workplaces generally predated e-cigarettes. Whether the same restrictions apply was unclear; objections grew as some users of vaping devices assumed they were exempt. More and more states and municipalities now explicitly prohibit ENDS wherever they prohibit smoking.

Some opposition to vaping stems from fear that young people will expose their developing brains to nicotine, and perhaps become addicted to other tobacco products. Some of that is happening. E-cigarette use by youth is on the rise even though their use of conventional cigarettes has declined. During 2011 to 2015, current users of e-cigarettes among high school students increased from 1.5 to 16.0 percent; among middle school students, from 0.6 to 5.3 percent. FDA regulations now ban sales of ENDS to individuals under age 18, and require ID proof of age through age 26. Prior to this rule, however, all but three states had already prohibited ENDS sales to minors. The FDA also stipulates that e-cigarettes and other tobacco products may no longer be given away, nor sold in vending machines accessible to young people.

The new FDA regulations direct manufacturers and importers of ENDS to submit, by May 2018, detailed premarket tobacco product applications (PMTAs) for every component of new and existing products including every flavor and concentration of e-liquid, unless an item was on the market by February 15, 2007 or is “substantially equivalent” to a product that was. This requirement will be difficult and expensive to satisfy and is expected to markedly reduce the selection of ENDS available to consumers.

Evidence of the risks of conventional smoking—including lung disease, cancer, and cardiovascular disease—is voluminous. The widely held belief that inhaling nicotine vapor is less risky than smoking may ultimately be proven correct. But that does not mean that nicotine vapor and the devices that produce it are benign. For example, some vapor may contain toxic or carcinogenic chemicals, nicotine may exacerbate heart problems, nicotine exposure in pregnancy can harm developing fetuses, nicotine solutions are poisonous to infants and toddlers, and lithium-ion batteries in ENDS have been known to explode, sometimes in the faces of users.

If you are a smoker and decide to take your chances with vaping (If you are not a smoker why would you assume the risks?), make yourself safer by cutting out conventional tobacco completely. Limit how long you engage in vaping. And resist identifying as a “vaper” or becoming a vaporizer hobbyist, which could embed the practice in your lifestyle.

The NCADD Addiction Medicine Update provides NCADD Affiliates and the public with authoritative information and commentary on specific medical and scientific topics pertaining to addiction and recovery.