In 2000, a Chinese pharmacist named Hon Lik invented the modern electronic cigarette, or e‑cigarette. The product uses a piezoelectric ultrasound-emitting element to vaporize a pressurized jet of liquid containing nicotine diluted in a propylene glycol solution. The “smoker” inhales the vapor through his mouth, simulating smoking. Though nicotine is addictive, e‑cigarettes are thought to be much less of a health hazard than their combustible tobacco cousins, for both smoker and bystanders.

In 2011, retail e‑cigarette sales in the United States reached $500 million, according to a recent Wall Street Journal article. Industry experts expect 2013 sales to reach $1 billion.

E‑cigarettes are not without their critics, who see them as “gateway” products to eventual tobacco use and nicotine addiction. Many of the critics want e‑cigarettes to be tightly regulated or removed from the marketplace altogether.

FDA weighs in | In 2009, the U.S. Food and Drug Administration’s Division of Pharmaceutical Analysis tested 19 varieties of e‑cigarettes manufactured by two vendors, NJOY and Smoking Everywhere. The scientists found that tobacco-specific nitrosamines, known cancer-causing chemicals, were detected in all of the cartridges of one brand, and two of the cartridges from the other. In July of that year, the FDA announced that it would publicly discourage the use of e‑cigarettes and raised concerns that they could be marketed to youth and that they did not have appropriate health warnings.

Critics of the FDA study responded that the detected harmful chemicals were measured by researchers at levels approximately one-millionth of the concentrations believed to be relevant to human health. Further, according to the results of a 2010 study by researchers at Boston University’s School of Public Health, the levels of carcinogens in e‑cigarettes are upwards of 1,000 times lower than tobacco cigarettes, had a level of toxicity similar to existing nicotine replacements (e.g., the nicotine patch, nicotine gum), and were found to be “much safer” than tobacco cigarettes.

Federal control | Nonetheless, the federal government has attempted to tightly control access to e‑cigarettes. On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act was enacted into law. An amendment to the venerable Food, Drug, and Cosmetic Act of 1938, the 2009 law gives the FDA authority to regulate products that are “made or derived from tobacco.” E‑cigarettes’ nicotine is typically derived from the tobacco plant, so the legislation put the product under FDA authority.

Under the law, the FDA initially labeled some e‑cigarettes as unapproved drug/​medical device combination products, a designation that gave the agency considerable authority to control the product’s availability. The FDA thus detained or refused to allow e‑cigarettes to enter the United States.

One e‑cigarette manufacturer, Sottera, challenged the FDA’s action in court. In December of 2010, the U.S. Court of Appeals for the D.C. Circuit issued a 3–0 decision striking down the FDA’s authority to regulate e‑cigarettes as a drug/​medical device. The U.S. Circuit Court subsequently held that e‑cigarettes and other products made or derived from tobacco can be regulated by the FDA as “tobacco products,” which limits the FDA’s ability to suppress the devices. In January of 2011, the D.C. Appeals Court declined to review the circuit court’s decision and the FDA decided not to appeal the decision further.

As a result of the Sottera decision, in April 2011 the FDA announced that it planned to take the following steps to institute regulatory mechanisms for all “tobacco products” and all other products made or derived from tobacco:

  • The FDA intends to propose a regulation that would extend the agency’s “tobacco product” controls under Chapter IX of the Food, Drug, and Cosmetic Act to other categories of tobacco products, as well as to the pre-market review requirements for “new tobacco products” and “modified-risk tobacco products.”
  • The FDA had previously issued draft guidance on products made or derived from tobacco regulated under the Tobacco Control Act (excluding those “marketed for therapeutic purposes”). The agency announced that it was considering whether to issue a guidance document and/​or regulation on the “therapeutic” claims of e‑cigarette manufacturers.
  • The FDA intends to finalize already-issued draft guidance on prohibiting the marketing of “tobacco products” in combination with other FDA-regulated products.
  • The FDA has already developed draft guidance explaining how manufacturers can request a determination from the agency that a “tobacco product” is “grandfathered” under Chapter IX requirements (i.e., marketed as of February 15, 2007), thus excluding the product from being subject to pre-market review as a “new tobacco product.”

The FDA is moving its planned e‑cigarette regulatory agenda forward. Last September, the agency issued an advanced notice of rulemaking (“Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products”) on possible regulation. The comment period closed in December. As of this June, the FDA’s rule (“Tobacco Products Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act”) is in the “Proposed Rule Stage.” In the above mentioned Wall Street Journal article, Mitch Zeller, director of the FDA’s Center for Tobacco Research, justified these steps by characterizing the present e‑cigarette marketplace as the “wild, wild West” in terms of federal regulations.

Possible regulation | E‑cigarette regulatory policy options enacted by state and local governments generally consist of the following:

  • Bans or restrictions on e‑cigarette marketing to minors, or making unsubstantiated marketing claims
  • Prohibiting e‑cigarette smoking in public places
  • Prohibiting e‑cigarette sales to minors

At the state and local level, there appears to be little resistance to public policy restricting the sale or marketing of e‑cigarettes to minors. Through 2012, 13 states had passed legislation prohibiting such sales. Several state and local governments have amended laws and ordinances against smoking in public places to include e‑cigarettes, and that push is certain to continue.

Wrong time for federal regulation? | The federal regulatory environment for e‑cigarettes is evolving, but it has been bounded by Sottera: e‑cigarettes are legally considered a “tobacco product.” The FDA will thus likely attempt to regulate e‑cigarettes in a fashion similar to tobacco cigarettes, and restrictions or bans will be initiated in the marketing and advertising of e‑cigarettes. But the extent of this regulation needs to be carefully crafted, as the health impacts of e‑cigarettes remain in scientific question. Beyond that, there is the question of what authority the FDA would have over e‑cigarettes that do not derive their nicotine from tobacco—these products, after all, would not be “tobacco products.”

The FDA will likely attempt to regulate e‑cigarettes in a fashion similar to tobacco cigarettes, and restrictions or bans will be initiated in their marketing and advertising.

Without a sound body of scientific knowledge to draw on, regulations requiring federal government warnings on e‑cigarette packaging and restricting advertising and variety of flavors are problematic. In the aforementioned Wall Street Journal article, Richard Carmona, former U.S. surgeon general and a previous supporter of an outright ban on the consumer use of tobacco products, argues that it is important to explore alternatives to traditional cigarettes because “initial information certainly suggests there is significant potential for harm reduction” associated with e‑cigarettes.

For those reasons, it is premature for the FDA to move forward with a regulatory agenda, if such regulatory policies discourage tobacco smokers from switching to potentially “less harmful to their health” e‑cigarettes. In June, the Centers for Disease Control and Prevention reported that the percentage of U.S. adult smokers had declined to 18 percent in 2012, down from 20 percent in 2011 (and the previous seven years). A safer alternative to traditional tobacco-based products, if technologically feasible, should be encouraged by regulators for the benefit of those who choose to continue smoking and wish to reduce the adverse health effects from their use of tobacco.