The Food and Drug Administration: Regulation of Electronic Cigarettes

Author: Stephanie Scott, Associate Member, University of Cincinnati Law Review

With so much of our daily lives being regulated by government agencies, it should come as no surprise that when a new product market emerges an administration will have something to say about it. Americans have been struggling with tobacco addictions since the early 1900s, and entrepreneurs have invented everything from hypnosis tapes, to nicotine gum, to skin patches to try and help users kick the habit. In the past few years, however, a new phenomenon has hit the states: the electronic cigarette. While this booming industry has been a gold mine for many entrepreneurs—and a success story for many “pack-a-day” tobacco users—it has also become a potential detriment to the overall public health of the population. The FDA should have authority to regulate this product and protect youth and unexpected sectors of the population from becoming victims of nicotine addiction.

Background

The U.S. Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”[1] The FDA also proposes to “advance[e] the public health by helping to speed innovations that make medicines more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need . . . to maintain and improve their health.”[2]  The FDA is also responsible for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.[3] Currently, the FDA regulates tobacco products including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.[4]

Tobacco Product Regulation

The Tobacco Control Act (aimed at protecting the public and creating a healthier future) gives the FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.[5]  According to its website, the “FDA’s approach to regulating tobacco products is grounded in science and uses the full power of the law to protect public health.”[6] Throughout the numerous goals and regulations outlined on the FDA’s website the overarching goal seems to center on protecting a healthier future and especially preventing youth from becoming users of these addictive nicotine products.[7] The website positions its marketing, advertising, and promotion requirements to allow companies and citizens to “get the latest guidance on new marketing rules and restrictions, especially efforts aimed to appeal to youth.[8] Some of the advertising and promotion restrictions include prohibiting tobacco brand name sponsorship by athletes, musicians, or social events; requiring audio ads to have no music or sound effects; prohibiting promotional items such as hats and tee shirts with tobacco brands or logos; and requiring that manufacturers receive a written order from the FDA permitting the marketing of a new tobacco product.[9]  Many of these requirements were established in the 2010 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.[10] The FDA also places restrictions on tobacco products labeled with certain terms such as “light” or “mild,” and requires larger and more visible warnings on smokeless tobacco packages and advertisements.[11]  These restrictive laws were expected to have a “significant public health impact by decreasing the number of people using tobacco products, resulting in lives saved, increased life expectancy, and lower medical costs.”[12]

Electronic Cigarettes

Electronic cigarettes (“e-cigs”) are battery-operated products designed to deliver nicotine, however, e-cigs allow users to inhale the nicotine as vapor instead of smoke.[13] More than 250 different e-cig brands are currently available on the market.[14] E-cigs work by vaporizing a chemical mixture of nicotine, flavoring, and other chemicals in an inhalable aerosol.[15] Because e-cigs are not “traditional” cigarettes, where health risks have been documented for decades, people often consider e-cigs a safer alternative.[16] While it is true that e-cigs do not have the same health risks resulting from the burning of tobacco, little is known yet about the actual health risks of using these devices.[17]

Regulation of Electronic Cigarettes

The FDA’s authority to regulate tobacco products currently only extends to traditional cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.[18] Tobacco continues to be the leading cause of preventable disease and death in the United States, despite decades of efforts to reduce the population’s tobacco use.[19] As the FDA strives to ensure and advance the public health, it has proposed a new rule to extend its authority to cover additional products that meet a new definition of a tobacco product.[20]  This proposed rule, “Tobacco Products Deemed To Be Subject to the Food, Drug, & Cosmetic Act” would include cigars, pipe tobacco, dissolvables, hookahs, and e-cigs.[21] Once this proposed rule becomes final, the FDA “will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death.”[22]

Why The FDA’s Authority Should Extend To Regulate Electronic Cigarettes

The FDA’s purpose continues to be promoting and advancing the general public health. While most of the categories it regulates (such as food and drugs) are primarily concerned with making sure the products help—not harm—the population’s health as a whole, tobacco is an entirely different category. Tobacco is an inherently dangerous product that the FDA must allow to exist and harm the public. However, the FDA has been able to focus its resources on making consumers more knowledgeable of the dangers, and preventing minors from ever beginning the habit or entering these product markets.

Currently there is no federal agency with authority to regulate e-cigs, so there are no federal age restrictions on the purchase or possession of e-cigs. Unless state or local law prohibits it, a 10 year old could walk into a vapor shop and purchase an e-cig.[23] While cigarettes have been regulated so as not to appeal in advertising, color, or flavor to children, e-cigs are quite the opposite. E-cigs are available in every color imaginable—pink, metallic gold, diamond embellishments, or even patterns—and are designed in ways that appeal to youth. Further, while cigarette manufacturers are unable to flavor their products, e-cigs offer nicotine vapor in a variety of flavors that are appealing to minors, such as chocolate and bubblegum. They’re often cheaper than regular cigarettes and not all of the product labels have a health warning. They can also be sold online and in mall kiosks, both very accessible locations for children and young adults.

While many argue that e-cigs are actually a positive advance to the overall health of the population because they created a “solution” to help 30-year, “pack-a-day” smokers finally quit smoking traditional cigarettes, there are many flaws with this argument.

There is no evidence available that e-cigs are actually healthier than traditional cigarettes. E-cigs are, in some respects, a better option than traditional cigarettes—i.e., they do not burn but rather vaporize, and do not contain many of the carcinogenic compounds created by burning tar.[24] Studies have shown, however, that there are a number of harmful chemicals in e-cigs including nitrosamine and diethylene glycol, a component of antifreeze “that’s toxic to humans and is banned in food and drugs.”[25] By granting the FDA authority to regulate e-cigs, a federal agency—which has experience in researching harmful products effects on the population—could conduct more bona fide research on these potential harms.

Further, because the product is currently not regulated, there is a presumption that this is a safe alternative and has encouraged individuals to begin using the product. This billion-dollar industry has removed many of the obstacles that have previously been successful in motivating people to quit smoking. With e-cigs, people are more likely to smoke indoors and are not discouraged from smoking by having to leave the comfort of their home to smoke in cold weather. Children are enticed by the colors and are able to legally buy them, in certain locations, at any age. Many members of the population that have already been successful in kicking a lifetime habit of smoking have picked up smoking e-cigs, an equally addictive product, and re-entered the market because they believe this is a “safe” alternative.[26] People who were discouraged from ever starting smoking cigarettes, because of the known health risks, have begun smoking e-cigs because of a belief that they are safe.[27] This has created an addiction to nicotine in a previously immune market. Addiction to nicotine may lead this sector to resort to traditional cigarettes when their e-cig is not available, or could become a gateway to traditional cigarettes.

Conclusion

While there may be arguments that e-cigs are a safer alternative to traditional cigarettes, there is not enough research available to know if this is true. Authority of the FDA to regulate this industry would allow more rigorous research and case studies on the true dangers of this product. Additionally, by bringing high levels of nicotine to the market in an unregulated way, it is getting large numbers of the population (that would otherwise be discouraged from consuming these dangerous products) addicted to nicotine products. Without regulation by the FDA, there is a threat that e-cigs will undo years of efforts to discourage the population from using these dangerous products. E-cigs are dangerous to the overall health of the population and therefore should fall within the FDA’s authority to regulate them.

[1] The Food and Drug Administration, What We Do, 2014, http://www.fda.gov/AboutFDA/WhatWeDo/default.htm.

[2] Id.

[3] Id.

[4] The Food and Drug Administration, What does FDA Regulate?, 2015, http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm.

[5] The Food and Drug Administration, Tobacco Control Act, 2015, http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm246129.htm.

[6] Id.

[7] Id.

[8] Id. (emphasis added).

[9] The Food and Drug Administration, Advertising & Promotion, 2015, http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/default.htm.

[10] Id.

[11] The Food and Drug Administration, Labeling, 2015, http://www.fda.gov/TobaccoProducts/Labeling/Labeling/default.htm.

[12] Id.

[13] National Institute on Drug Abuse, DrugFacts: Electronic Cigarettes, 2015, http://www.drugabuse.gov/publications/drugfacts/electronic-cigarettes-e-cigarettes.

[14] Id.

[15] Id.

[16] Id.

[17] Id. e.g. testing of some e-cig products found the vapor to contain known carcinogens and toxic chemicals, such as formaldehyde and acetaldehyde, as well as potentially toxic metal nanoparticles.

[18] The Food and Drug Administration, Deeming – Extending Authorities to Additional Tobacco Products, 2015, http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm.

[19] Id.

[20] Id.

[21] Id.

[22] Id.

[23] Center for Disease Control and Prevention, States laws prohibiting sales to minors and Indoor use of Electronic Nicotine Delivery Systems – United States, November 2014, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6349a1.htm (A total of 40 states prohibit e-cig sales to minors, but approximately 16 million children under 18 can legally purchase e-cigs in the remaining ten states, including the district of Columbia).

[24] UTMB Health, Are e-Cigarettes Safe?, http://www.medicaldiscoverynews.com/shows/264-ecigs.html.

[25] Id.

[26] Center for Tobacco Control Research and Education, Substantial evidence of e-cigarette use among never and former smokers (both adults and youth): that’s not harm reduction, November 11, 2014, https://tobacco.ucsf.edu/substantial-evidence-e-cigarette-use-among-never-and-former-smokers-both-adults-and-youth-thats-not-harm-reduction (32.5% of current e-cigarette users were never or former smokers; at least 18.4% –  nearly 1 in 5 – e-cigarette users are people who would not be using nicotine and being exposed to the other toxins in e-cigarettes if e-cigarettes were not on the market.)

[27] Id.

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