FDA Moves to Regulate E-Cigarettes

The days of unregulated e-cigarettes might be up in faux smoke.

The Food and Drug Administration has announced proposed rules that would treat e-cigarettes like tobacco cigarettes with regard to marketing and testing, including age restrictions barring sales to minors and FDA reviews of new products.

Leaders of the “vaping” community, a term that users of e-cigarettes and more high-tech nicotine-vaporizing devices have embraced, fear that additional regulation will kill the industry and limit their access to tobacco alternatives.

The FDA says the proposals, which come amid recent scrutiny of the industry, are part of its ongoing efforts to cut tobacco use. In 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act, and the new rule “would extend the agency’s tobacco authority to cover additional tobacco products,” according to an agency statement.

The products that would be included under these proposed regulations “are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority.” At present, the FDA regulates cigarettes, tobacco for roll-your-own cigarettes and smokeless tobacco.

This means several things for e-cigarette makers. These producers would have to register with the FDA and “report product and ingredient listings”; they would be allowed to market new products only after an FDA review; they would not be allowed to give out free samples; and they wouldn’t be able to make “direct and implied claims of reduced risk” unless the FDA vets these claims.

The FDA would also ban vending machine sales, unless the vending machine is “in a facility that never admits youth,” such as a bar. Finally, the FDA would require health warnings.

In a press conference call on Thursday, top U.S. public health officials, including FDA Commissioner Dr. Margaret A. Hamburg and FDA Center for Tobacco Products Director Mitch Zeller, celebrated these proposals. Hamburg described them as an “important moment for consumer health and protection.”

It’s not the age restrictions or marketing regulations that have vapers and shop entrepreneurs particularly worried. In fact, the vaping industry has long called for instituting age restrictions and responsible marketing, Joe Barnett, founder of the Vaping Militia, tells Newsweek. Rather, it’s the demand for testing of each new product that could deal a blow to producers, he says.

The overwhelming majority of the approximately $2 billion U.S. vaping industry consists of small businesses, many of whom make products such as nicotine-containing liquids themselves, Barnett explains. In addition, the vaping industry hinges largely on individualized products, resulting in an infinitesimally wide variety of flavors and nicotine concentrations from thousands of small companies. Vaping business owners fear that these FDA regulations might require that every single producer will have to submit every single flavor—at every nicotine level—to FDA review, resulting in a costly backlog.

“The FDA’s attempt to regulate may have inadvertently damaged a bourgeoning industry,” Barnett says. “I’m not sure we’ll recover. It’s just that simple.”

To be clear, the FDA proposals are still in the proposal stage. And while FDA proposals typically do become the law of the land, some wouldn’t kick in for a while. There’s a 75-day public comment period before the FDA issues final rules. Upon their issuance, the FDA is giving a manufacturers two years to submit applications and product review requests. The FDA would not come down on e-cigarette makers for selling their wares while these applications are under review—as long as they submit applications before the 24-month deadline. E-cigarette products developed after that 24-month deadline, however, could not be marketed without prior approval.

Also, the rules wouldn’t apply to all e-cigarettes or high-tech vaping devices—nor to certain vaping liquids that don’t contain nicotine—so long as they do not have anything to do with tobacco, officials said. The restrictions on age and vending machines would go into effect immediately.

Although the health impact of e-cigarettes has long been up for debate, the FDA was cautious not to decry e-cigarettes as dangerous per se during the conference call. The FDA’s Zeller said a pack-a-day smoker might be better off on e-cigarettes than combusting tobacco cigarettes. Even the proposed warning label is slated to advise users only that nicotine is addictive. However, officials say they worry about the broader public health trends that haven’t been examined with testing, specifically whether e-cigarettes might interest children in smoking.

The vaping community, which of late has ramped up lobbying efforts, is sure to put up a tough fight against the proposed regulations. Many vapers are former cigarette smokers and believe that e-cigarettes have helped them kick a dangerous tobacco habit. The FDA’s increased scrutiny of vaping was largely prompted by that belief. The Obama administration is concerned that this attitude will thwart anti-smoking efforts and recognized smoking-cessation techniques, such as nicotine patches and gum.