The Food and Drug Administration is finally going to start regulating e-cigarettes and other tobacco products such as cigars and hookah the same way it regulates cigarettes, according to a much-anticipated federal rule published on Thursday.
Importantly, this means the agency now has jurisdiction over all tobacco products in the US — including the $3 billion e-cigarette industry that wasn't previously under its control.
"We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth," said Sylvia Burwell, who oversees the FDA as secretary of the US Department of Health and Human Services, in a news release. She noted that while cigarette smoking among teens has fallen, "the use of other nicotine products, including e-cigarettes, has taken a drastic leap."
Mitch Zeller, director of the FDA's Center for Tobacco Products, said the new rule will address the "the wild, wild west" that is the current e-cigarette market, and the agency billed today's announcement as "a milestone in consumer protection."
Stakeholders in the vaping and cigar industries, who previously sold their products without regulatory oversight, see it differently. They've been fervently lobbying against the regulation, and say that these new rules will kill off many companies, including e-cigarette purveyors selling safer alternatives to traditional smoking. Here's what you need to know.
Until now, the FDA had no authority over products like e-cigarettes
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration the power to regulate the tobacco industry. But e-cigarettes — along with other tobacco-related merchandise such as cigars and nicotine gels — were left out.
In April 2011, the FDA announced it was going to address this gap because of health concerns about the products. In April 2014, the agency proposed a draft rule that will redefine e-cigarettes as "tobacco products." That rule, published in this 499-page document, has just been finalized, which means all tobacco products will now be FDA-regulated under the Tobacco Control Act.
The slow regulatory process isn't the only reason for the lag: Starting in 2008, the FDA attempted to clamp down on e-cigarettes by other means. And it failed.
The FDA argued that e-cigarettes — which hit the market here around 2006 — were unapproved drug delivery devices, since they were being touted as potential smoking-cessation aids. The companies fought back, saying they weren't actually marketing e-cigarettes that way. They successfully sued the FDA in the federal court and the US Court of Appeals, which helped delay the possibility of oversight — until today.
The rule will ban sales of e-cigarettes and other tobacco products to minors, among other big changes
The rule, which took more than two years to finalize, will:
- Ban e-cigarette, hookah, pipe tobacco, and cigar sales — either in person or online — to minors (some states have already done this)
- Require age verification by photo ID for purchase of these products
- Require manufacturers of products that hit the market after February 15, 2007, to register with the FDA and submit their products for FDA approval — disclosing ingredients, safety and emissions data, and manufacturing processes — within 12 to 24 months depending on the regulatory pathway followed
- Require companies to put health warning labels on e-cigarettes and other tobacco products, including warnings of the possibility of addiction and the health effects of nicotine
- Prohibit selling of covered tobacco products in vending machines (unless in an adult-only facility)
- Ban free samples of e-cigarettes and other tobacco products
These new regulations will take effect in 90 days.
Not all public health advocates will be happy with the new regulations
The rule is nearly 500 pages long, so commentary will take a while to roll in. But here are some places where the rule will likely fall short.
First, the FDA's rule didn't include some other restrictions that health advocates called for. In particular, it doesn't address the use of certain flavors in e-cigarettes and other tobacco products — like bubblegum and lemonade — that the advocates argued were aimed at children and youth.
There's also the lag time. Companies now have to get approval for their products, but it could take about three years to get the ones that are potentially dangerous and wouldn't pass muster off the market. Why? Because the FDA is allowing companies to continue to sell their products for up to two years while they submit their applications to the agency — and for another year during the approval process.
Meanwhile, there's a separate contingent of doctors and health advocates who see vaping as a good way to move people off regular cigarettes and think the new regulations might go too far. They have worried that if e-cigarettes are regulated too heavily, or become too expensive because of the cost of regulatory compliance, the public could miss out on a device that might save lives.
Some experts also think heavy (and expensive) regulation could halt innovation, deterring manufacturers from creating more advanced devices with better nicotine delivery systems that could help reduce smoking.
As Peter Hajek, a professor at Queen Mary University of London, put it, "Regulators need to watch out for unintended consequences of overzealous regulation, such as stifling such developments or making e-cigarettes more expensive and less attractive to smokers; and also avoid conveying a message that e-cigarettes are regulated as strictly [as] or even more strictly than cigarettes because they are as bad."
E-cigarette makers have long complained that regulations could wipe them out
One big, open question is how the new rule will impact the e-cigarette market.
E-cigarettes have become increasingly popular here in recent years. In 2015, the Centers for Disease Control and Prevention (CDC) reported that the use of e-cigarette devices among middle school and high school students tripled between 2013 and 2014. That means about 13 percent of students now use them — outstripping the number who smoke conventional cigarettes. By 2017, sales of e-cigarettes in the US are expected to surpass those of conventional cigarettes, reaching $10 billion.
Until now, these products have not had to go through any federal regulatory approval processes. And manufacturers and advocates have been fighting regulations on the grounds that they could kill the industry. According to the American Vaping Association, the regulations are akin to prohibition and a gift to the tobacco industry, since they'll put so many companies out of business.
Jeff Stier, an e-cigarette advocate with the National Center for Public Policy, estimated that each FDA application will cost upwards of $1-million, according to USA today.
Mitch Zeller, director of the FDA's Center for Tobacco Products, had a more modest estimate. He says the cost of compliance to the new rule should run into the "hundreds of thousands of dollars" per application. He also said the FDA is building "efficiencies" into the regulatory process that will make it less costly for companies to apply over time.
The long-term health effects of vaping are unclear — though it appears to be safer than smoking in the short-term
Here's the bottom line: If you're a chronic smoker looking for a nicotine fix and trying to decide between smoking and vaping, most experts would agree there’s a compelling case that e-cigarettes are less harmful.
But a nonsmoker, or an ex-smoker, should think twice before taking up the habit. Even if e-cigarettes are safer than regular cigarettes, that doesn't mean they're totally safe. At this point, we just don't know. As an American Heart Association review on e-cigarettes states: "In general, the health effects of e-cigarettes have not been well studied, and the potential harm incurred by long-term use of these devices remains completely unknown."
Based on the short-term studies we do have, exposure to e-cigarettes doesn’t appear to carry serious, immediate health effects. As the AHA points out, "The data on health effects to date, studied primarily in healthy people with short-term exposure, reveal little or no evidence of severe adverse events."
Keep in mind, however, that the research here is still early, and this conclusion could change once we have data on tens of thousands of e-cigarette users rather than just dozens or hundreds.
Bigger questions center on the toxicity of e-cigarette’s main ingredients — propylene glycol or vegetable glycerin, as well as chemical flavorings — and their potential long-term health effects.
Maciej Goniewicz, of Roswell Park Cancer Institute, is one of the leading researchers in this area. In one study, he looked at 12 brands of e-cigarettes and found that their vapors were mostly composed of propylene glycol or vegetable glycerin.
Though propylene glycol and glycerin are generally considered safe substances, not a lot is known about the long-term effects of daily inhalation, Goniewicz says. There’s some evidence from theater settings — in which propylene glycol has been used to create fog — that suggests it can be a lung irritant. Goniewicz has also found toxic substances and cancer-causing compounds, such as formaldehyde and acetaldehyde, in e-cigarettes.
The AHA has also noted, "Respiratory irritation and the bronchial constriction from a propylene glycol aerosol raise concerns about harm to people with asthma and chronic obstructive pulmonary disease."
Reasons for concern have popped up elsewhere — though, again, nothing conclusive yet. Some research has shown that cells exposed to e-cigarette vapor showed similar genetic changes as cells exposed to conventional cigarette smoke, raising concerns that e-cigarettes could potentially lead to lung cancer.
One big problem here: E-cigarette products vary widely, making them tough to study. "Some had a higher presence of the toxicants, while other products have very low levels or even undetectable levels of toxicants," Goniewicz said. What's more, research shows that the heating process in e-cigarettes can change the composition of potentially harmful chemicals. "If the temperature goes too high, then there are more toxicants," he warned.
All that said, e-cigarettes may be significantly less harmful than conventional cigarettes. Goniewicz's study found that the levels of toxicants and carcinogens in e-cigarette vapor were nine to 450 times less prevalent than in conventional cigarette smoke.
Chris Bullen, an e-cigarette researcher and professor at the University of Auckland's School of Public Health, noted that newer electronic cigarettes use a heating control mechanism that prevents "cooking" the liquid inside them, reducing the risk of generating cancer-causing chemicals. But he cautioned about drawing conclusions from older studies that may be based on out-of-date technology.
The evidence on whether e-cigs will help people quit smoking is mixed
Because e-cigarettes appear to be safer than traditional cigarettes, there's been cautious consensus from groups like the UK's Royal College of Physicians that these devices might be beneficial to public health.
But the evidence on whether they help people actually quit smoking altogether is still limited and has mixed results.
So far, two randomized studies (here and here) have looked into the question of quitting, and both found that e-cigarettes may indeed help smokers stop. Another lower-quality web-based survey came to the same conclusion.
But not everyone's convinced. As a systematic review by the Cochrane Library noted: "The small number of trials, low event rates and wide confidence intervals around the estimates mean that our confidence in the result is rated 'low.'"
For example, there were weaknesses in the randomized trials. One trial compared e-cigarettes with nicotine patches for helping people quit. But participants had to go out and pick up the patches from the pharmacy, whereas e-cigs were delivered to their doorsteps — a difference that could have biased the results in favor of e-cigarettes.
Other evidence, meanwhile, suggests that e-cigarettes may not be so effective at helping people smoke fewer traditional cigarettes. A study published in JAMA Internal Medicine in 2014 concluded: "E-cigarette use by smokers was not followed by greater quitting, or reduction in consumption one year later."
Another 2015 study in the journal Addiction found that daily use of e-cigarettes seemed to be associated with an increase in the rate of attempts to quit smoking and less smoking, though not increased rates of quitting. These were both observational studies and so were lower quality than the randomized trials.
And there are lots of harder questions that remain unanswered, as the American Thoracic Society has noted. Could e-cigarettes prolong the process of quitting? Could they make quitting less likely if, for example, smokers use them in settings where cigarettes have been outlawed? For now, we don't know. The new regulations from the FDA may force answers sooner than later.