E-Cigarettes Now On FDA’s Radar

e-cigarettes

Eight years have elapsed since the introduction of electronic cigarettes, and the Food and Drug Administration (FDA) is just beginning to hold meetings to discuss how these devices are made and the potency of their ingredients.

Why now? Because e-cigarettes have attained a meaningful, and growing, toehold in the nicotine delivery business. The market for “vaping” — the curious term that has supplanted “smoking” because e-cigarettes users inhale vapor in place of smoke — has grown exponentially. This year, Americans will spend about $2.2 billion on more than 400 brands of e-cigarettes, numbers that exceed the patches and gums associated with nicotine-replacement therapy (NRT), according to a recent editorial in the New England Journal of Medicine (NEJM).

The FDA is naturally concerned about any inhaled product. But there is no doubt that e-cigarettes in the wrong hands have the potential to cause significant public harm. A few weeks ago, a toddler in upstate New York accidentally died from swallowing liquid nicotine, a major ingredient found in e-cigarettes, which is toxic at certain doses. It is not clear yet how the 1-year-old got hold of the liquid nicotine, but e-cigarette packaging is not child-resistant, one of the major concern for regulators.

Are e-cigarettes safe? Are they effective? Oh, and what are they, exactly? A drug? A device? Both?

The FDA wants to know, now that new research shows respiratory dangers and an increased number of unintended poisonings from liquid nicotine.

E-cigarettes have been regarded as “generally safe” because they do not contain cancer-causing agents produced by burning tobacco. But in April 2014, a study by RTI International, a North Carolina research institute, was released showing that e-cigarette “vapors” are made of small particles containing chemicals that are sucked deep into the lungs, and may cause or worsen acute respiratory diseases, including asthma and bronchitis, among youth.

This concerns the American Lung Association (ALA). “We certainly don’t believe e-cigarettes are a safe alternative [to conventional cigarettes],” said Dr. Norman Edelman, senior medical advisor for the ALA. “The question is whether it’s a safer alternative, and we believe those results aren’t in yet. This is a tobacco product and should be regulated by the FDA as all tobacco products should.”

The technology of the device is also changing rapidly. Many devices are now reusable, so a consumer can refill them with liquid nicotine, solvents and flavorings. Spills happen — which raises the danger of liquid nicotine being absorbed through the skin. This can potentially cause rapid heart beat, elevated blood pressure, along with nausea, vomiting, diarrhea, dizziness confusion and potentially seizures that can lead to coma and death. And those flavorings, like cinnamon and cherry, may be considered “safe” when ingested — but what happens when they are inhaled?

The FDA has finally stepped up.

The FDA currently regulates traditional cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The FDA Center for Drug Evaluation and Research (CDER) regulates only e-cigarettes that are marketed for therapeutic purposes.

Now, the rapid increase in recreational use of e-cigarettes has caught the FDA’s attention.

For 8 hours each day on December 10 and 11, the FDA and the Center for Tobacco Products (CTP) held public meetings to focus on the science behind the product’s device designs and characteristics, e-liquid and aerosol constituents, product packaging, constituent labeling and environmental impact.

Quality Control? It Depends…

Technically speaking, e-cigarettes are electronic nicotine delivery systems (ENS) — that is, battery-powered devices that deliver nicotine and other additives, including glycerin, propylene and ethylene glycols (the main ingredient in antifreeze) and flavorings, to the user through inhaled vapor.

e-cigarettesThe ingredients are heated by an element powered by a battery, which turns those ingredients into an aerosol that is inhaled through a mouthpiece. E-cigarettes resemble thick ball point pens, but brands and models differ in design, as well as their efficacy and consistency of nicotine vaporization.

It doesn’t take a rocket scientist to make an e-cigarette, so manufacturing can happen in a basement as well as in a sophisticated chemistry lab. In China, which produces about 90% of the world’s e-cigarettes, according to a recent New York Times article, “China’s E-Cigarette Boom Lacks Oversight for Safety,” numerous health hazards, including high levels of heavy metals, have been found in the products.

Why the Lack of Standards?

U.S. companies make e-cigarettes, but unlike other industries — toys, apparel and smartphones — where global brands outsource their manufacturing in China but monitor and enforce quality control standards, the e-cigarette industry in China has developed differently, according to the Star-Tribune. Chinese companies were the first to develop e-cigarettes, and that happened in a regulatory void. In other words, industry standards never existed.

Concerns voiced in the recent FDA/CTP forum came from manufacturers, designers, engineers, poison control experts, toxicologists and public health advocates. These are some of the problems with e-cigarettes, to name a few:

  • Lack of uniform manufacturing standards
  • Unchecked potency of carbonyls and nicotine
  • Leaching of heavy metals, including nickel and cadmium
  • Questionable marketing of umpteen flavorings, including bubblegum, vanilla cupcake and “Cialis”
  • Overheating batteries that can explode
  • Unregulated claims on packaging, which is not childproof
  • The potential for the user to refill the liquid chamber with potentially harmful ingredients, causing unintended — or even intended — consequences

While the FDA ponders these challenges, at least one Florida-based e-cigarette company, White Cloud Cigarettes, is bringing manufacturing back home, having recently relocated the entirety of their cartridge production process from overseas to the U. S., says Electronic Cigarette Consumer Reviews LLC.

So what’s the upside?

With e-cigarettes, which vaporize nicotine effectively, the amount of nicotine inhaled from 15 puffs is lower than that consumed by smoking a conventional cigarette, according to the Nicotine & Tobacco Research journal.

Proponents note that e-cigarettes can help people quit smoking and believed that they were less harmful than conventional cigarettes because they were thought to contain fewer carcinogens.

But others, including the FDA, contend that e-cigarettes have not been fully studied and potential risks are unknown, especially to minors. In addition to the recent RTI study showing risk of respiratory diseases, another concern is that e-cigarettes may lead to smoking conventional cigarettes, especially among young people.

Just recently, The New York Times reported that the National Institute on Drug Abuse released a new study of more than 41,000 U.S. middle- and high-school students which found that e-cigarette use among teenagers has surpassed the use of traditional cigarettes, even as smoking of traditional cigarettes has continued to decline.

What are the long-term consequences of e-cigarettes?

No one really knows, according to health experts, manufacturers, engineers, advocacy organizations and e-cigarette users who attended the FDA/CTP meetings.

But stay tuned. The FDA plans 2 additional e-cigarette workshops: one on individual health effects and one on population health effects. In addition, the CTP is currently funding 37 research projects related to e-cigarettes to determine risks.

Are regulations coming for e-cigarettes?

The FDA says that the information presented and discussed during the workshop series is not intended to inform the Agency’s rulemaking related to deeming additional tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act.

But the information-gathering through public comments and research projects may lead to regulations in the future.

The e-cigarette industry seems open to FDA involvement to ensure that the products are safely manufactured for all parts of the world, but there is also a fear that strict regulations will favor big tobacco companies, which have the time and money to comply if clinical trials and rigorous manufacturing standards are required.

One wonders what will happen in the meantime.

The Centers for Disease Control and Prevention (CDC) reports that the number of calls to poison centers involving e-cigarette liquids containing nicotine rose from one per month in September 2010 to 215 per month in February 2014, and more than half of the calls involved young children under age 5.

And yes, 16 million minors, age 17 and under, can still buy e-cigarettes in 10 states and the District of Columbia, according to a CDC report.

“We know e-cigarettes are not safe for youth,” said Tim McAfee, M.D., M.P.H., director of CDC’s Office on Smoking and Health. “While ENDS (electronic nicotine delivery systems) may have the potential to benefit established adult smokers if used as a complete substitute for all smoked tobacco products, ENDS should not be used by youth and adult non-tobacco users because of the harmful effects of nicotine and other risk exposures, as well as the risk for progression to other forms of tobacco use.”

Meanwhile, in Fort Plain, New York, where the toddler died from drinking liquid nicotine, the Albany CBS affiliate reported that “lawmakers like Assemblyman John McDonald are pushing for childproof caps to become a requirement on liquid nicotine vials sold in New York State,” adding that “more needs to be done on a federal level since this product is marketed in a way that can be enticing to children.”

“If you look at these little bottles they almost look like candy bottles and therefore to a young person it’s attractive,” McDonald said. “Now I don’t think anyone makes them that way with that intention but the reality is they’re trying to market the scent of the vapor. ”

NEJM underscores the need for action in its recent “Perspective” editorial:

“Until the FDA enforces oversight and regulation of e-cigarettes, the safety of individual devices cannot be assumed. For smokers choosing among forms of refined nicotine, NRT [nicotine replacement therapy] products still represent safer, more predictable choices, even if they are more expensive and less appealing. This discrepancy is unfortunate, given the public health potential of e-cigarettes that consumers could assume to be safe, reliable, and effective. We would encourage the FDA to accelerate their regulations to eliminate uncertainty regarding safety, drive the substitution and use of clean nicotine, and hasten the demise of lethal combusted tobacco.”

Reading the “T”-leaves?

During the FDA/CTP meetings all cigarette use, including vaping, was prohibited. Hmmm… that may be an indication of where the regulatory authorities are headed.


Sarah Smedley

Sarah Smedley

Sarah Smedley has 20 years’ experience in communications for the medical, pharmaceutical, biotech, consumer health, fitness, philanthropy and nutrition industries. She is now a freelance writer and frequent contributor to The BROADSHEET, a daily online and bi-weekly print newspaper.


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