The official blog of the Lung Institute.

E-Cigarettes and the FDA’s E-Cigarette Regulations

10 May 2016
| Under Lifestyle, Lung Disease, Smoking | Posted by
| 1 Comment
E-Cigarettes and the FDA’s E-Cigarette Regulations

For people who smoke traditional cigarettes but want to quit, smoking e-cigarettes may seem like a good alternative. Proponents of e-cigarettes claim that, without the harmful effects of traditional cigarette smoke, e-cigarettes still deliver nicotine through e-liquid vapor that contains it. Until now, e-cigarettes were unregulated by the U.S. Food and Drug Administration (FDA). After years of debate, the federal government has ruled that e-cigarettes need to be regulated to protect the public and kept out of the hands of children. Here’s what you need to know about e-cigarettes and the FDA’s e-cigarette regulations.

What are e-cigarettes?

Electronic cigarettes, also known as e-cigarettes, are a considered a popular tobacco product and include e-pens, e-pipes, e-hookah, e-cigarettes and e-cigars. Collectively, these devices are known as electronic nicotine delivery systems (ENDS). E-cigarettes allow users to inhale vapor containing nicotine and/ or other substances. Unlike traditional cigarettes, e-cigarettes are typically battery operated and use a heating element to heat the e-liquid from a refillable cartridge, which releases a chemical-filled vapor.

What is in e-cigarettes?

E-Cigarettes and the FDA’s E-Cigarette RegulationsE-liquid is the main component in the refillable cartridges of e-cigarettes. The e-liquid is created when nicotine is extracted from tobacco and mixed with a base, such as propylene glycol, and it may also include flavorings, colorings and other chemicals.

Because there has not been government or FDA evaluation or regulation of these products, there’s no way for people to know what chemicals are actually in the e-liquids or how e-cigarettes might affect short or long-term health. However, early studies have shown that e-cigarettes contain nicotine and also may have other harmful chemicals, including carcinogens. Nicotine is an addictive substance and is found in almost all e-cigarettes.

Initial FDA Lab Tests Findings

While there is still a lot to study and learn about e-cigarettes and what they contain, initial FDA lab tests conducted in 2009 found that cartridges labeled as nicotine-free had traceable amounts of nicotine. In another study in 2014, of the e-cigarettes containing nicotine, the amount of nicotine in the e-liquid refills was often substantially different from the amount listed on the package.

In the initial FDA lab tests, other chemicals were also found, including toxic cancer-causing chemicals and antifreeze. Another study found that vapor from e-cigarettes with a higher voltage level contains formaldehyde. Flavors in e-cigarettes also pose a threat and are targeted to children. While little is known about the emissions or potential harm they may cause, two initial studies found secondhand emissions from e-cigarettes contain formaldehyde, benzene and nitrosamines—all of which are carcinogens.

In addition to the concerns, calls to poison control centers related to e-cigarette exposure have increased rapidly, and these calls are typically related to children, according to the Centers for Disease Control and Prevention (CDC).

E-Cigarettes and the FDA’s E-Cigarette Regulations

E-Cigarettes and the FDA’s E-Cigarette RegulationsAfter years of no regulation, the FDA now has rules for the producers of e-cigarettes for the first time. Now, producers of e-cigarettes will be required to register with the FDA and provide a detailed account of their products’ ingredients as well as their manufacturing processes. Producers will have to apply to the FDA for permission to sell their products, which will include vape shops that mix their own e-liquid. Producers will be subject to FDA inspections and will not be allowed to market their products as light or mild without agency approval. Companies will also be prohibited from giving away free samples. While little is known about the potential effects of vaping, e-cigarette use and secondhand emissions of vaping, the new regulations and more studies will shed light on this controversial topic.

At the Lung Institute, we want you to have all the facts you need about e-cigarettes and the FDA’s e-cigarette regulations so that you can make the best decisions for you. We will continue to bring you information about chronic lung diseases, treatment options, tips to quit smoking and lifestyle modifications to help you have the best quality of life possible.

* Every patient is given a Patient Satisfaction Survey shortly after treatment. Responses to the 11-question survey are aggregated to determine patient satisfaction with the delivery of treatment.

^ Quality of Life Survey data measured the patient’s self-assessed quality of life and measurable quality of improvement at three months of COPD patients.

All claims made regarding the efficacy of Lung Institute's treatments as they pertain to pulmonary conditions are based solely on anecdotal support collected by Lung Institute. Individual conditions, treatment and outcomes may vary and are not necessarily indicative of future results. Testimonial participation is voluntary. Lung Institute does not pay for or script patient testimonials.

As required by Texas state law, the Lung Institute Dallas Clinic has received Institutional Review Board (IRB) approval from MaGil IRB, now Chesapeake IRB, which is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP), for research protocols and procedures. The Lung Institute has implemented these IRB approved standards at all of its clinics nationwide. Approval indicates that we follow rigorous standards for ethics, quality, and protections for human research.

Each patient is different. Results may vary.