Basic questions about e-cigarettes and other vaping devices will need to be answered as the FDA begins to regulate the booming industry.
E-cigarettes are a way for smokers to cut down or kick their deadly habit, or are they simply another way for them to satisfy their cravings? They are seen as an alternative to smoking, but with appealing flavors and greater safety, and e-cigarettes are also a diversion for a generation of would-be smokers away from the dangers of cigarettes.
Do e-cigarettes reduce non-smokers’ unintended exposure to tobacco smoke or replace it with other toxins? Do they expose children to nicotine-containing cartridges that have been shown to be dangerous if ingested? Or are they no more dangerous than a load of commercial laundry?
Are e-cigarettes a public health hazard or a necessary public health benefit? The question remains unanswered.
When it comes to assessing the health effects of e-cigarettes in the United States, the FDA, the agency responsible for regulating the issue, said Thursday that one thing is clear: The effects of these devices that deliver nicotine without the smoke are a hot topic of debate.
Studies to support the FDA's proposals have produced mixed results. It's a race to catch up in a market that's already $7.3 billion and growing at a rapid pace.
“When the FDA looks at the claims made by e-cigarette marketers, they can find clear evidence of harm,” said research professor Rebecca Williams of the University of North Carolina's Lineberger Comprehensive Cancer Center.
Hundreds of brands and related products are available to American consumers, Williams said, and so far, none have come under scrutiny.
Many manufacturers, including those outside the United States, do not have to adhere to manufacturing standards, she said. They are not required to disclose the ingredients in their products or prove that they are safe. Some flavors used have been shown to be safe when ingested, but are dangerous when burned or inhaled. And there have been reports of vaping devices catching fire and exploding.
These seem like easy cases to happen.
In the coming years, the FDA will have to grapple with a number of questions about e-cigarettes and the rapidly expanding range of vaping devices, experts say: Even if they pose a risk to users, are they safer than regular cigarettes, and if so, under what circumstances?
Regulators have a hard time seeing through health claims about these products. Some even argue that heating nicotine to get to the brain faster could help Americans live longer, healthier lives.
But the FDA will often be asked to weigh in on the “harm reduction” potential of these devices — it’s a much more complex calculation than deciding which products can pass muster and what marketers can say, and the agency will need to answer some basic questions.
“This is certainly a complex problem, and the industry has fueled this complexity,” said Clifford Douglas, director of the University of Michigan Tobacco Research Network.
For the first time, the FDA is taking a hard look at the vaping industry’s claims that its products have long-term health benefits for Americans. And they have taken advantage of the FDA’s silence to continually expand their market.
Regulators need to show that some types of vaping devices can help smokers quit, a claim that can only receive limited support from research results.
“There is some evidence that smokers who switch to vaping can quit smoking,” says William.
But she also said there are smokers who continue to use both — a fact that both maintains their addiction and overshadows the physiological improvements when they quit smoking and use only e-cigarettes.
“They need to understand how often e-cigarette use leads to smoking among those 18 and over, who have limited exposure to marketing,” she added.
Regulators will also need to figure out how much of the chemicals vaping releases are less harmful to people around them. Williams said there are some larger vaping devices in use that heat nicotine to higher temperatures to produce more vapor. “Even if you produce more vapor, are the chemicals in it safe for children, restaurant workers, and others who are exposed to it?” she said.
Dr. Roy Herbst acknowledged the change. As chief of medical oncology at Yale University Medical Center and chairman of the American Association for Cancer Research and Tobacco Control Committee, he noted that more than 190,000 people die from lung cancer each year and that cigarettes contain more than 100 chemicals that are toxic to the lungs.
“I can see how people think this is a better solution,” says Dr. Herbst. Although he remains skeptical, he says, “I would love to see some good research showing that this, when used properly and out of the reach of children, is less dangerous than cigarettes. It’s certainly something worth looking into.”
“The FDA has a difficult task of balancing the potential risks and potential benefits of e-cigarettes to protect public health,” said Thomas Brandon, director of the tobacco research and intervention program at Moffitt Cancer Center. “This task is especially difficult because, at this point, we still don’t know all the benefits and harms of e-cigarettes. The health effects of long-term vaping and the onset of nicotine dependence in adolescents. And the benefits of the potential to reduce harm when smokers switch to vaping.”
“The most vocal proponents and opponents of e-cigarettes will probably be unconvinced, but I believe the public will be satisfied with these regulations,” said Brandon, who led a $3.6 million NDIA (National Institute on Drug Abuse) investigation into the harms and benefits of the devices.
