Reducing the harm associated with tobacco use is a legitimate aim. ... What is needed to determine how best to achieve this is good-quality science...
-- Jeff Stier, senior fellow at the National Center for Public Policy Research.
To obtain this "good quality science," the U.S. Food and Drug Administration next month will announce a new regulation "deeming" electronic cigarettes (e-cigarettes) and the nicotine-laced e-liquid that fuels them to be products subject to the Food, Drug, and Cosmetic Act. Products that, like tobacco, need government regulation.
"Once the proposed rule becomes final," according to the FDA, the agency "will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death."
But is that necessarily a good thing? Is it a bad thing?
The kids are all right (but are they right?)
According to data from the Centers for Disease Control and Prevention, the percentage of Americans who smoke cigarettes is at an all-time low today. Only 17.8% of adults in the United States smoke, down more than 50% in the last 50 years.
Importantly, the rate of teen cigarette use has recently plummeted to just 9.2%, defying historical trends by falling below the rate of adult smoking. There has been an especially steep drop-off since the 2003 introduction of "vaping" e-liquid as an alternative to smoking tobacco.
Today, some 8% of adults say they have tried e-cigarettes -- half the smoking rate. Recent CDC findings, though, indicate that teens (the ultimate "early adopters") actually prefer vaping over smoking. E-cigarette use among high school students nearly tripled from 4.5% in 2013 to 13.4% in 2014, even as smoking rates plummeted.
If, as their defenders claim, e-cigarettes are less dangerous to use than analog cigarettes, then teens appear to be moving toward a safer vice of choice.
What does the FDA want to know?
Which brings us to the FDA and its proposed regulation of e-cigs. This week, the Smoke-Free Alternatives Trade Association, or SFATA, held its annual conference in Chicago, featuring speakers such as Stier (quoted above) discussing the "significant challenges" posed by FDA regulation.
On its official website, the FDA highlights four questions it wants to answer once e-liquid has been "deemed" essentially the same as a tobacco product:
- the "potential risks of e-cigarettes";
- how much "nicotine or other potentially harmful chemicals" e-liquid contains;
- whether there are any benefits to the use of e-cigarettes; and
- whether e-cigarettes are a gateway leading teens to try "conventional cigarettes."
Regulating e-liquid: The risks...
Congress's hometown newspaper, The Hill, quoted Consumer Advocates for Smoke-free Alternatives Association President Julie Woessner as warning that FDA regulation could "wipe out" the e-cigarettes industry. That would doom the hundreds of millions of dollars that tobacco companies Reynolds American (NYSE:RAI) and Altria (NYSE:MO) have sunk into their Vuse and Green Smoke e-cigarette businesses.
The bigger threat, though, isn't to the makers of the e-cigarettes themselves -- which are generally fairly generic devices, incorporating a battery-powered heating element that warms e-liquid into a vapor for inhalation. The real worry is that the FDA will crack down on small businesses manufacturing the e-liquid itself.
According to the FDA, regulation of e-liquid would include requiring manufacturers to "report product and ingredient listings" and "only market [e-liquid] after FDA review." The New York Times reported that applying for FDA approval of a new e-liquid formula could easily consume "more than 5,000 hours and cost more than $300,000." These are costs that the hundreds of storefront "vape shops" would have real difficulty absorbing. Large, multinational companies, in contrast -- the kinds that investors focus on -- could easily absorb the costs.
... and benefits
A more optimistic way to look at FDA regulation, however, is its potential benefit. Taken at its word, the agency's primary concern in "deeming" e-liquid to be similar to a tobacco product is gaining the authority to conduct scientific analyses of the chemicals that "vapers" are putting in their lungs. In short: to confirm, once and for all, whether vaping is safer than smoking -- and if so, whether it's effective as a means of getting people to quit smoking.
If these tests prove vaping's defenders are correct -- that's great! More than a decade after e-cigarettes came on the market, all sides of the debate should welcome having some real scientific evidence of this fact. It would surely help to grow the market for e-liquids.
But if these tests prove that vaping advocates' claims are bunk -- well, we should all probably want to know that, too.