Safety and Regulation of E-cigarette Use in the U.S.

The safety of this product is still in question. In 2009, the Food and Drug Administration’s Center for Drug Evaluation, Division of Pharmaceutical Analysis (DPA) conducted a preliminary analysis of 18 of the various flavored nicotine and no-nicotine cartridges.37 The contents were tested for ingredients potentially being carcinogenic or harmful to humans. The samples detected:

  • 1% diethylene glycol, an ingredient used in antifreeze and toxic to humans.
  • Tobacco specific nitrosamines, a chemical compound which are human carcinogens were detected in 50% of the samples.
  • Tobacco specific impurities: anabasine, myosmine, and β-nicotyrine, which are all carcinogens.
  • The e-cigarette cartridges that were labeled as containing no nicotine had low levels of nicotine present.
  • Variability among nicotine levels that were labeled as containing the same levels of nicotine, ranging from 26.8-43.2 mcg nicotine/100mL puff.

However, due to variability among products, the analysis could not draw specific conclusions about what substances are or are not present in particular liquid nicotine samples.24

Two other research papers concluded e-cigarettes vapors do, in fact, contain some trace amounts of impurities or toxic substances that were stated on the product labels and were much lower than the amount found in traditional cigarettes and, therefore, less harmful to the body. Both articles indicated future studies were needed to fully assess its contents.25,26

Initially the FDA sought regulation of e-cigarettes as drugs or drug delivery devices. The following timeline follows the development of regulation:

Figure 6. E-cigarette Development of Regulation Timeline.

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  • 2008: The FDA moved regulation of e-cigarettes as drugs or drug delivery devices by blocking importation of new e-cigarette shipments into the U.S.
  • 2009: Major e-cigarette manufacturer (Sottera), sued the FDA claiming that the “agency didn’t have the authority over e-cigarettes as drugs or drug delivery devices and therefore could not stop shipments from entering the country.”
  • January, 2010: District court agrees with the manufacturer determining that FDA may not regulate e-cigarettes as a drug or drug delivery device.
  • December, 2010: The FDA appealed the lower court’s ruling. The circuit court upheld the initial ruling and found that e-cigarettes can be regulated under FDA’s “tobacco product” authorities. Unless they are “marketed for therapeutic purposes” (including as cessation devices), in which case, they are regulated as drugs and/or devices.56 Because the Sottera products are not marketed as tobacco cessation aids the FDA does not have authority over the product as it is marketed.
  • April 25, 2014, FDA issued a proposed rule that would extend its tobacco product authority to cover additional products including e-cigarettes.57
  • August 8, 2016, FDA finalized a rule to regulate all tobacco products. extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco, as part of its goal to improve public health.77

States vary in terms of use and regulation of e-cigarettes, with some states and localities having implemented a Smoke-Free Workplace Law by requiring more indoor workplaces to be smoke free and prohibit smoking within 10 feet of entrances, exits, windows that open, and ventilation intakes of workplaces or public places. However, most states do not include e-cigarettes in this category of smoke free environments.31,38

“Before this final rule, these products could be sold without any review of their ingredients, how they were made, and their potential dangers, under this new rule, we’re taking steps to protect Americans from the dangers of tobacco products, ensure these tobacco products have health warnings, and restrict sales to minors.” Explains Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.77

It requires health warnings on roll-your-own tobacco, cigarette tobacco, and certain newly regulated tobacco products and also bans free samples. In addition, because of the rule, manufacturers of newly regulated tobacco products that were not on the market as of February 15, 2007, will have to show that products meet the applicable public health standard set by the law. And those manufacturers will have to receive marketing authorization from the FDA.77

The new rule also restricts youth access to newly regulated tobacco products by: 1) not allowing products to be sold to those younger than 18 and requiring age verification via photo ID; and 2) not allowing tobacco products to be sold in vending machines (unless in an adult-only facility).

It’s important to note that FDA regulation of these products does not mean they are safe to use. But before this rule, there was no federal law to stop retailers from selling e-cigarettes, hookah, or cigars to youth under age 18.77

It is recommended that health professionals contact local governmental agencies to determine if rules and regulations have been implemented against the use of e-cigarettes in their respective states. Also, health professionals can use online resources that track state and local legislation.60,61