As of Jan. 14, 2,668 individuals in the United States and its territories have been hospitalized with e-cigarette, or vaping, product use-associated lung injuries (EVALIs). Nevertheless, the Centers for Disease Control and Prevention (CDC) has softened its approach toward e-cigarettes such that its new recommendations practically endorse e-cigarette use by certain populations. This article examines the CDC's abrupt change in position on e-cigarettes and analyzes the efficacy of the CDC's new guidance.

The CDC's Retreat From Common Sense

On Aug. 30, 2019, the CDC issued a health advisory related to e-cigarette use. That advisory included recommendations for clinicians, public health official, and the public at large. The first recommendation issued to the public was straightforward without being alarmist: "While this investigation is ongoing, if you are concerned about the specific health risks associated with e-cigarettes, consider refraining from using e-cigarette products." On Jan. 17, the CDC abandoned that message.

The CDC's website now includes several web pages devoted to e-cigarettes. One of these web pages is titled "For the Public." On that page, the CDC provides readers with an overview of its e-cigarette investigation before identifying new consumer-oriented recommendations. The CDC dedicates most of this overview to two conclusions. First, "THC-containing e-cigarette products are linked to most EVALI cases." Second, "Vitamin E acetate is strongly linked to the EVALI outbreak." Regarding its second conclusion, the CDC emphasizes that health agencies discovered Vitamin E acetate in product samples and lung fluid samples taken from EVALI-diagnosed patients, but not in lung fluid samples taken from healthy individuals.

The CDC's new consumer-oriented recommendations include the following advice: "Vitamin E acetate should not be added to any e-cigarette … product. Additionally, people should not add any other substances not intended by the manufacturer to products, including products purchased through retail establishments." These recommendations leave readers with the impression that every documented case of EVALI has been explained by third-party e-liquid adulteration or that the victims of the EVALI outbreak added Vitamin E acetate to their own vaping materials. Both inaccuracies absolve manufacturers of liability and promote consumer use of "safe" factory-sealed e-cigarette products.

Although the CDC includes a nondescript concession that "evidence is not sufficient to rule out the contribution of other chemicals of concern [to the EVALI outbreak,]" the agency does not mention any other chemical on its "For the Public" page. Instead, viewers must follow separate links to learn that aerosol inhaled from e-cigarettes includes ultrafine particles, flavorings, volatile organic compounds, cancer-causing chemicals and heavy metals. As the following sections explain, the CDC's misleading statements could result in life-threatening conditions for unaware consumers.

Manufacturer-Included E-Liquid Ingredients

The CDC identifies a single flavoring compound by name on its website—diacetyl. Yet, the CDC only asserts that "it is a chemical linked to a serious lung disease." The CDC does not explain how it is dangerous or how consumers may avoid it while using e-cigarettes. Such information would be useful to consumers as researchers have isolated it in dozens of e-cigarette flavors.  See, e.g., Joseph G. Allen, "Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes," 124 Env. H. Perspectives 733 (2016) (concluding that diacetyl was measured in 39 of the 51 analyzed e-liquid flavors).

Food manufacturers add diacetyl to products to replicate buttery and caramel flavors. Correspondingly, many consumers have eaten diacetyl-flavored foods and not suffered adverse effects. Diacetyl is dangerous when it is inhaled. Under such conditions, it can lead to bronchiolitis obliterans, a lung injury that was first experienced by microwave popcorn factory workers (leading to the nickname "popcorn lung"), see Watson v. Dillon Companies, 797 F. Supp. 2d 1138, 1154 (D. Colo. 2011). Popcorn lung diagnoses are not unheard of among consumers who vape. Recently, U.S. District Court Judge William Orrick of the Northern District of California, who presides over the multidistrict litigation pending against JUUL Labs, asked attorneys to report how many plaintiffs were diagnosed with the disease.

The etiology of popcorn lung demonstrates that the distinction between ingestion and inhalation is crucial to consumer safety. E-cigarette manufacturers should have used this well-documented difference as guidance. Using said guidance, they should have determined whether other flavor compounds that are generally regarded as safe for consumption have detrimental effects on human respiratory systems. To date, it seems as if they did not commission such testing. Had they done so, they may have discovered that some of the other compounds that they use, including cinnamaldehyde, benzyl alcohol and triacetin, induce cytotoxic changes in human cells, see Rachel Z. Behar, "Analytical and Toxicological Evaluation of Flavor Chemicals in Electronic Cigarette Refill Fluids," Scientific Reports, May 29, 2018, at 1, 9.

The presence of diacetyl and other flavoring compounds in e-cigarette products undercuts the CDC's new consumer-oriented recommendations. Even if consumers refrain from adding substances to prepackaged e-cigarette products, they will not be safe. Vitamin E acetate is not responsible for every EVALI diagnosis. Manufacturers are adding substances to their products that are either unequivocally or potentially dangerous when inhaled. The CDC's recommendations further fail to notify consumers that the devices they are using—not just the e-liquid they are vaping—pose a related and real safety hazard.

Even Unaltered E-Cigarette Devices, Themselves, Are Not Without Risk

The CDC's "For the Public" web page informs consumers that "states typically conduct various levels of testing on products, including testing for potency, contaminants, metals, pesticides, and pathogens." The only other consumer-oriented CDC web page that touches upon heavy metals posits that "e-cigarette aerosol … can contain harmful and potentially harmful substances, including … heavy metals such as nickel, tin and lead." The CDC does not inform consumers through either web page that at least one e-cigarette user has been diagnosed with heavy metal poisoning subsequent to vaping. The corresponding case report is instructive as it demonstrates that, through poor material choices, e-cigarette manufacturers are contaminating their own products.

Specifically, a 49-year-old female used a ZenPen e-cigarette for six months, presented to the hospital with severe respiratory symptoms, and was diagnosed with giant cell interstitial pneumonia secondary to cobalt exposure (also known as cobalt lung). Her treating physicians had the remaining liquid in her ZenPen analyzed for 10 metals: aluminum, arsenic, cadmium, chromium, cobalt, lead, manganese, molybdenum, nickel and tungsten. High levels of each metal but tungsten were detected in the device. The patient's physicians theorized that the metal contaminants originated from the device's heating elements and leached into the liquid that their patient vaped, see Daffolyn Rachael Fels Elliott, "Giant Cell Interstitial Pneumonia Secondary to Cobalt Exposure from E-Cigarette Use," Eur. Respiratory J., Dec. 4, 2019, at 1.

Manufacture-provided temperature settings can also place consumers in danger. For example, formaldehyde, a volatile organic compound, is a known carcinogen. It is also a byproduct of propylene glycol and glycerol (two primary ingredients in most e-liquids). When propylene glycol and glycerol are heated at low voltages, they do not produce quantifiable formaldehyde emissions. When subjected to higher voltages, they expose consumers to 290 to 470 micrograms of formaldehyde per 10 puffs from an e-cigarette. Contrastingly, an average conventional cigarette exposes consumers to approximately 150 micrograms of formaldehyde. According to researchers, this difference in exposure rates could mean that e-cigarette users are five to 15 times more likely to develop cancer than conventional smokers, see R. Paul Jenson, "Hidden Formaldehyde in E-Cigarette Aerosols," 372 New Eng. J. Med. 392, 392 (2015).

Promoting Caution Saves Lives

A small part of the CDC's message has remained constant between its 2019 health advisory and its current recommendations: "E-cigarette, or vaping, products should never be used by youths, young adults or women who are pregnant. Adults who do not currently use tobacco products should not start using such products." However, these sentences are premised upon the harmful effects of nicotine—not the dangers unique to e-cigarettes. Moreover, that part of the CDC's message disregards the safety of smokers and is overshadowed by the CDC's apparent endorsement of e-cigarette manufacturers.

The American Heart Association has taken a hardline approach toward vaping, informing consumers that "anyone who says vaping is safe is just blowing smoke." The American Medical Association has called for a ban on all e-cigarette and vaping products. Even if these positions are overly protectionist and select e-cigarette products are safe, published case reports reveal that other products pose a severe danger to consumer health. As such, the CDC should not ask the public to trust the latest industry to market untested products or to continue using products whose design ignores sound scientific principles.

In lieu of understating the dangers that e-cigarettes represent, the CDC should provide the public with an objective representation of the risks associated with known e-cigarette ingredients. Thomas Gray's observation that ignorance is bliss has previously been applied to public safety. The results were unquestionably disastrous. Americans were convinced that smoking was healthy. The dangers of secondhand smoke were recognized decades too late. Thousands of workers were unaware that asbestos caused mesothelioma or that take-home exposure could deliver a death sentence to their loved ones. Unfortunately, the CDC has forgotten that harboring ignorance related to public safety is synonymous with promoting unnecessary pain and suffering.

James M. Andris Jr. is an associate at Anapol Weiss. He focuses his practice on products liability, mass tort/toxic tort and class action litigation. Contact him at [email protected].