Juul Labs, the e-cigarette producer that has dominated the market, received a warning letter from the Food and Drug Administration for its marketing tactics. The manufacturer has proclaimed its product to be less harmful than traditional tobacco cigarettes, without first gaining federal approval to promote such a claim. The marketing claim publicly pronounced by Juul Labs is a violation of federal regulations and the FDA’s letter is a major setback for the e-cigarette giant. The warning was issued just as the manufacturer was attempting to rebrand itself in the midst of a public outcry against teenage vaping.

Investigation into Juul’s Practices

Before the mysterious lung illnesses of summer 2019 occurred, an investigation into Juul’s practices had already begun. Concerns over the manufacturer’s sales practices and marketing techniques have prompted testimony to Congress by Juul executives, anti-smoking activists, parents, and students.

Specific instances of violations by Juul were cited by the FDA, including a talk that was given at a school by a Juul representative where students were told that Juul “was much safer than cigarettes” and was “totally safe.” Additionally, a statement by chief executive Kevin Burns was once posted on the Juul website and said the company’s vaping system is designed to “heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and harm associated with it.”

Acting FDA Commissioner Dr. Ned Sharpless notes, “Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does, in fact, pose less risk or is less harmful.” He continued, “Juul has ignored the law and, very concerningly, has made some of these statements in school to our nation’s youth.”

Targeting Youth

Juul has cornered more than 70 percent of the U.S. market in e-cigarette sales. The increased use of vaping products by teenagers is very concerning to officials at the FDA, particularly in light of the fact that teens are especially vulnerable to nicotine addiction.

Juul vaping products contain a high level of nicotine. This gives rise to concerns regarding the long-term effects of such levels of nicotine on the developing brains of teenagers. Could these products lend themselves to become a gateway drug that catastrophically reverses several decades of a steady decline in smoking?

Because the long-term effects of e-cigarettes are unknown, and research is at a very early stage, the FDA sees the need to restrict marketing assertions by Juul Labs and other vaping product companies. The agency is giving Juul 15 days to submit a plan to correct the issues delineated in the warning letter. Per Juul company spokesman Matt David, “We are reviewing the letters and will fully cooperate.”

A second letter was sent to Juul by the FDA that seeks further documentation of the company’s practices and any scientific evidence Juul has amassed to prove claims and details regarding some products, including nicotine-salt e-liquids.

Juul’s Wording in Question

Regarding Juul’s ad campaign called “Make the Switch,” the FDA believes the message is conveyed in a way that says the company’s vaping devices are not as harmful as tobacco cigarettes. Public health experts and lawmakers have taken aim at this advertising campaign, contending that the message indicates Juul’s vaping products and devices are a smoking cessation option. Representative Raja Krishnamoorthi, a Democrat from Illinois, commented saying, “I have a hard time seeing the difference between quit and switch.” She further adds, “Essentially, what they are saying is quit smoking, and do something different.”

However, a spokesman for Juul, Joshua Raffel, did not agree. “Switching is not another word for cessation or safer.” He continued, “They mean very different things. For example, switching involves continuing to consume nicotine but from a different device, while cessation is about getting users to eliminate their nicotine consumption altogether.”

Juul has been at the center of concerns by the FDA and public health experts for over a year due to the appeal of its products to teens and youth. The sleek, slimline vaping device Juul produces has become a status symbol among young people.

Juul’s Meteoric Rise

Financially and culturally, after the company’s product line appeared on the scene in 2015, things began to skyrocket for Juul. The company was valued at $16 billion by 2018. Today, however, the estimated valuation has more than doubled to $38 billion, thrusting Juul to a spot that ranks it among the most successful growth stories in recent times in Silicon Valley.

The company opened itself up to further scrutiny when it sold 35 percent of Juul Labs to a leading cigarette company, Altria. This pairing ignited even greater criticism, signifying to opponents that Juul’s ultimate concern is only profits, no matter the cost in regard to the public’s health. Juul adamantly denies this assertion. A leading cigarette manufacturer, Philip Morris International, and Altria are now talking about a merger that would open up huge markets overseas for Juul.

It is unclear if the actions taken by the FDA will damage Juul’s domestic sales, even though the company purports that sales have already been hurt after it decided to cease shipping flavored pods to sales outlets. The FDA warned the company of what could happen if Juul doesn’t comply with the laws governing vaping products:

• An injunction
• Civil penalties imposed
• Seizure of company products

Are Regulatory Actions Necessary?

E-cigarettes have grown in popularity at a rate that has surpassed any regulatory framework connected to the product. Public health experts and regulators are faced with the question of whether the potential benefits of this new technology will outweigh the risks involved, particularly regarding young people.

E-cigarette companies have been given several FDA deadlines for submission of evidence that their vaping products will serve public health. The companies must also agree to submit to full regulatory authority. Juul has never submitted an application to gain approval from the FDA to market its vaping products as a healthier choice. A federal judge ruled in July that the FDA would have to move its deadline up to May 2020 as the time for all companies to comply.

An argument is presented by Juul’s defenders and those who advocate for using e-cigarettes as a device to assist in smoking cessation. The argument is that U.S. regulatory policies are unfair to Juul and to the public health message. David Sweanor, a tobacco-law expert at the University of Ottawa, advocates for the use of e-cigarettes as an alternative to tobacco smoking. “Communicating that their products are certainly massively less hazardous than cigarettes is accurate and non-misleading,” he says.

Sweanor notes that the lung illnesses being linked to vaping haven’t been shown to be directly linked to mass-marketed e-cigarettes. He believes policymakers should remember the massive toll smoking is taking when it kills 1,300 individuals per day in the U.S. Others, however, like Dr. Nora Volkow of the National Institute on Drug Abuse leans toward potentially making e-cigarettes only available by prescription if the product proves effective for smoking cessation after future clinical trials.

Contact a Vaping Injury Lawyer Today

If you or a loved one has suffered lung problems from the use of an e-cigarette, call KBA Attorneys. Our product liability lawyers have years of experience in fighting against large corporations who have sold dangerous devices and falsely advertised their products. You may qualify for a Juul lawsuit and financial compensation.

Find out if you are eligible, contact us today.

References

Sheila Kaplan and Matt Richtel. “Juul Illegally Marketed E-Cigarettes, F.D.A. Says”, The New York Times, https://www.nytimes.com/2019/09/09/health/vaping-juul-e-cigarettes-fda.html. Accessed September 11, 2019.