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:
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.
“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