New FDA Rule Prohibits Sale of E-Cigarettes to Anyone Under Age 18 and Requires Warning Labels


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I certainly hope this regulatory move is going to at least reduce the popularity and increase in using [e-cigarettes] among kids. Hopefully, we will be able to debunk a lot of myths around these so-called innocent or risk-free products.

—Alexander V. Prokhorov, MD, PhD

A new rule extending U.S. Food and Drug Administration (FDA) oversight to all tobacco products, including electronic cigarettes (e-cigarettes), and banning the sale of these products to anyone under the age of 181 was hailed as a major advanced by many leaders of medical and health organizations. The announcement of the new rule was called a boost in the fight for a tobacco-free generation, by Health and Human Services Secretary Sylvia Burwell.2 “This is a crucial step in further regulating deadly tobacco products,” echoed ASCO President Julie M. Vose, MD, MBA.3

“It is a great step,” Alexander V. Prokhorov, MD, PhD, told The ASCO Post. He is Director of the Youth and Family Cancer Prevention Program and the Tobacco Outreach Program and Distinguished Professor, Department of Behavioral Science, at the University of Texas, MD Anderson Cancer Center, Houston. “One of the important risk factors for smoking initiation among young people and adolescents is access to the product. We learned from studies that pertained to cigarette smoking that restricted access reduces smoking initiation, and we can extrapolate this finding to e-cigarettes as well,” he said.

Without FDA oversight, access to e-cigarettes was limited only by the state law in some states and the discretion of the seller in states without a state law, but once the new rule goes into effect on August 8, sales will be restricted to those over 18 years old under Federal law. Vending machine sales in places accessible to those under 18 and distribution of free samples will be prohibited.

Must Report All Ingredients

The new rule bringing all tobacco products under FDA oversight also applies to cigars, hookah tobacco, and pipe tobacco. Manufacturers, importers, and/or retailers of the newly regulated products will now need to comply with the Family Smoking Prevention and Tobacco Control Act, which since 2009 has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products. Requirements include registering, reporting all ingredients as well as harmful and potentially harmful substances, and obtaining FDA authorization to market new products. Representatives of the e-cigarette industry generally found the new requirements onerous.

Alexander V. Prokhorov, MD, PhD

Alexander V. Prokhorov, MD, PhD

Health warnings will be required on product packages and advertising. Reduced-risk advertisements and labeling such as “light,” “low,” and “mild” cannot be used unless authorized by the FDA. “Manufacturers of newly regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of February 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users,” according to the FDA.4 “Under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to 3 years while manufacturers submit—and the FDA reviews—a new tobacco product ­application.”

What’s in the E-Juices?

Dr. Prokhorov welcomed the required disclosure of the ingredients in the “e-juice”—the liquids containing nicotine and other substances that are vaporized and then inhaled, a process known as vaping. “We have evidence that if you inhale this vapor, there are some substances in it that are carcinogenic, such as formaldehyde,” Dr. Prokhorov added.

There are many different types of e-juices, he noted, and some list organic components. “That is really appalling,” he said, because “organic in our minds is usually associated with a healthy product, but because we know that even if these e-juices have some kind of organic ingredient, they also have nicotine. Then we are certainly dealing with a product that is a high risk, especially to young people,” Dr. Prokhorov said. “There were a lot of unknowns for us researchers and for the public about e-cigarettes. Now they have to tell the FDA exactly what they put in those e-juices.”

Nicotine Is Dangerous

“Nicotine is dangerous and highly addictive, whether it comes from an e-cigarette, hookah, cigarette, or cigar. Research has clearly demonstrated that exposure to nicotine at a young age increases the chance that kids will become addicted,” according to the FDA.

In a previous interview with The ASCO Post in 2013, when the recently announced regulations were originally expected, Dr. Prokhorov used the word “poison” to describe nicotine and noted that experimentation with extreme doses can kill. A study published by Pediatrics online found that calls to Poison Control Centers related to exposure to e-cigarettes and liquid nicotine among young children increased 1,500% between January 2012 and April 2015, and one child died.5 (A law taking effect in July will require child-resistant closures for liquid nicotine containers.) An earlier study found, “Human and animal data support that nicotine exposure during periods of developmental vulnerability (fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development, and altered development of the cerebral cortex and hippocampus in adolescents.”6

Dr. Prokhorov credits the rising popularity of e-cigarettes with “prompting more careful investigation of how nicotine influences or affects young persons’ brains. A lot of discoveries have been made that pertain to nicotine affecting this brain in a negative way. So we cannot just say it is one of those products that we can live with or consider it entirely risk-free or safe.”

Flavors Not Yet Addressed

Not addressed by the new rule—and a concern for some who think the rule does not go far enough—are e-cigarette flavors, such as bubblegum and marshmallow, which may especially appeal to young people. “A lot of kids try this product because they are attracted by these flavors. It is for a good reason that flavors, except for menthol, were banned in tobacco products,” Dr. Prokhorov stated.

The flavor of e-cigarettes “is one of those things that entices them, and then the ingredient that they don’t think about much, which is nicotine, makes them hooked on these products. That is the usual well-known trick of the tobacco industry to retain people in the world of nicotine and continue to sell their product. That is why my vote would be certainly to ban flavors. Eventually, I hope that is going to happen.”

Skyrocketing Use by High Schoolers 

A survey supported by the FDA and the Centers for Disease Control and Prevention (CDC) “indicates current e-cigarette use among high school students skyrocketed from 1.5% in 2011 to 16% in 2015 (an over 900% increase).”4 Contributing to the popularity of e-cigarettes may be the variety and design of the devices used to create the vapor and deliver the nicotine. These electronic nicotine delivery systems come in a variety of forms. There are so-called cigalikes that look like cigarettes, and there are devices that look nothing like cigarettes,” Dr. Prokhorov explained.

“People attempt to experiment with these products to increase the amount of vapor coming out,” he continued. Some young people post videos on YouTube to “show how much vapor they can produce, vapor rings, and tricks. That is something I remain concerned about because social media picked up this issue, and that makes me nervous about the future of our ability to control this. It is getting viral when kids share their ‘talent’ in creating vapor rings. In the process, unfortunately, it may get lost that the e-juice contains nicotine and remains a very dangerous product,” Dr. Prokhorov commented.

“I certainly hope this regulatory move is going to at least reduce the popularity and increase in using them among kids,” Dr. Prokhorov commented. Young people “probably will see that it is not an entirely innocent and harmless product, as it is usually positioned by the industry,” he added. “So, hopefully, we will be able to debunk a lot of myths around these so-called innocent or risk-free products.”

Maintaining Addiction

“The growing use of e-cigarettes has sharply divided American public health interests. The central question is whether they help people stop smoking—or whether they are a gateway to traditional cigarettes,” according to a recent article in The New York Times.7 Dr. Prokhorov has stated that e-cigarettes “absolutely” may serve as a gateway to traditional cigarettes but acknowledged, “I don’t think there is an agreement in the scientific community even among people who study e-cigarettes and tobacco.”

Some people advocate trying to switch all smokers who cannot quit traditional cigarettes to e-cigarettes, because at least that would be less harmful, he explained, whereas others advocate e-cigarettes as “a good addition to our armamentarium of other quitting aids. Dr. Prokhorov continued, “My perspective is basically informed by over 35 years of working with youth: It is extremely dangerous because essentially what we do is we maintain addiction in the society and renormalize the use of maybe not burning tobacco but some tobacco smoke-like substance. If we renormalize this behavior, it’s easy to see the trajectory, maybe all the way back to smoking combustible tobacco products. Young people can start with e-cigarettes, but once they get addicted to nicotine, it is a lot easier for them to switch to conventional tobacco products.”

He pointed out that even with the increased use of e-cigarettes, “I have not seen or heard from the tobacco industry that they are going to discontinue their regular cigarettes or tobacco products. So this is a tricky way to delay elimination of tobacco from society. It is a way to maintain nicotine dependence and recruit young people,” he said.

“There is also dual use,” he noted. Some young people smoke cigarettes in places permitting that but switch to e-cigarettes in other circumstances. “That again is maintenance of nicotine addiction in society,” Dr. Prokhorov stated.

21 Would Be Even Better

At about the same time as the new FDA rule was announced, it was reported that the age for legally purchasing all nicotine and tobacco products had been raised to 21 in California. Asked if he would like to see the age raised nationwide, Dr. Prokhorov replied, “Absolutely. I would like to see that.”

“The Tobacco 21 initiative is a very good move,” Dr. Prokhorov added. That initiative is a focus of the Preventing Tobacco Foundation. In a statement congratulating California Governor Jerry Brown and the legislature for raising the age to 21, the Foundation’s President Rob Crane, MD, wrote: ‘This action puts tobacco sales in line with other high-risk products like alcohol and handguns and recognizes that 95% of all smokers initiate to this deadly addiction before age 21.”8

“The older the age of legal purchase of these products, the less likely people are going to adopt smoking behavior,” Dr. Prokhorov noted. “It is absolutely crystal clear to me that the older people get, the better they understand what they do to themselves by smoking and the less likely they will decide to make it a part of their lives.” What they do to themselves, Dr. Prokhorov stressed, is not only increase their risk of lung cancer and other types of cancer, but of other chronic diseases. “The laundry list of these diseases is getting bigger and bigger,” he noted.

“I feel a lot more confident now and a lot more satisfied with this FDA action, because I think it is an historic move,” Dr. Prokhorov remarked. “We know that it is a lot better to inform people correctly about what they do to themselves and no longer have that mystery around this product. I am glad that we are on the right track.” ■

Disclosure: Dr. Prokharov reported no potential conflicts of interest.

References

1. Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products: A Rule by the U.S. Food and Drug Administration, May 10, 2016.

2. FDA takes significant steps to protect Americans from dangers of tobacco use through new regulation. FDA press release, May 5, 2016.

3. ASCO applauds U.S. Food and Drug Administration (FDA) for regulating e-cigarettes. Statement from ASCO President Julie M. Vose, MD, MBA, May 5, 2016.

4. U.S. FDA takes significant steps to protect Americans from dangers of tobacco use. FDA Fact Sheet, May 5, 2016.

5. Kamboj A, Spiller HA, Casavant MJ, et al: Pediatric exposure to e-cigarettes, nicotine, and tobacco products in the United States. Pediatrics. May 5, 2016 (early release online).

6. England LJ, Bunnell RE, Pechacek TF, et al: Nicotine and the developing human: A neglected element in the electronic cigarette debate. Am J Prev Med 49:286-293, 2015.

7. Tavernise S: F.D.A. imposes rules for e-cigarettes in a landmark move. The New York Times, May 5, 2016.

8. Making history in California: Governor Brown signs the Tobacco 21 Bill. Statement of Rob Crane, MD, President, Preventing Tobacco Addiction Foundation, May 4, 2016.


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