FDA Raid Seizes Thousands of Documents from E-Cigarette Maker Juul

Natural Society

E-cigarette maker Juul Labs received a surprise inspection from the U.S. Food and Drug Administration (FDA) on September 28, with the agency walking out with more than 1,000 documents. [1]

The move is part of an effort by the FDA to pressure Juul, whose products are highly popular among teenagers, to do more to keep e-cigarette products out of the hands of young people. Juul controls 72% of the e-cigarette market in the United States, and the FDA said October 2 that it was investigating whether the company was deliberately targeting minors in its sales and marketing practices.

In a statement, the FDA said:

“The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens. It is vital that we take action to understand and address the particular appeal of, and ease of access to, these products among kids.”

The surprise inspection follows an April request made by the FDA for Juul’s marketing and research data. The company had already coughed up upwards of 50,000 pages of internal documents to the agency in response to that request, according to Kevin Burns, the company’s chief executive officer.

Burns said:

“We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access.”

FDA Commissioner Scott Gottlieb said there is growing concern among the agency over the skyrocketing use of e-cigarettes in high schools and even middle schools, saying the problem had reached “epidemic proportions.”

The use of e-cigarettes among high-schoolers in the last 30 days has catapulted by roughly 75% since last year to about 3 million, preliminary unpublished data released by the FDA show. E-cigarette products are especially tempting for young people because of the many candy-like flavors available, a problem that Gottlieb has repeatedly decried.

Another reason for Juul’s popularity among teenagers is the device’s USB flash drive-like design. The devices are easy to hide and it’s easy to fool teachers and administrators, who often assume it is a real USB drive used for schoolwork. [2]

Or it was easy to fool them until their popularity skyrocketed.

The FDA’s concern is compounded by evidence that vaping can lead to other harmful behaviors. A study published in January suggests that e-cigarettes are the “gateway” to smoking cigarettes for teens. Researchers found that teenagers who start vaping are 2-1/2 times more likely to become regular smokers within a year. [3]

That study is supported by a RAND Corporation study of 2,039 Californians ages 16 to 20 beginning in 2015 through 2017, released October 2. The findings show that as teenagers who used e-cigarettes aged, many moved onto traditional tobacco cigarettes. By the end of the study period, more than half of e-cigarette users were also smoking cigarettes. [1]

The gateway theory is all well and dandy, but it can easily be argued against. I’d say we’re simply in a similar situation as when cigarettes were popularized, where social pressures and image are at the core of the growing popularity.

Then, there’s this: A report published in JAMA by the U.S. Centers for Disease Control and Prevention (CDC) on October 2 reveals that Juul Lab’s sales jumped from 2.2 million devices in 2016 to 16.2 million devices last year. The data only encompassed sales originating from retail stores. With the prevalence of online sales, it’s likely that number is significantly higher.

E-cigarettes are touted as being safer than cigarettes, which is true – to a point. While they lack the carcinogens created by burning tobacco, they contain high levels of extremely addictive nicotine, particularly Juul, which can have negative effects on the developing brain. There is also a cocktail of chemicals in vaping juice, though again, not as much as cigarettes.

In September, the FDA gave Juul and 4 other e-cigarette manufacturers 2 months to find a way to prove to the agency that they had taken steps to prevent the sale of their products to young people. Gottlieb warned that companies that failed to do so could be required to:

• Change their sales and marketing practices

• Stop distributing products to retailers who sell to kids

• Remove flavored e-cigarettes – and nicotine products – from the market

Juul recently launched its own multimillion-dollar campaign of posters for high school bathrooms and public service announcements on popular websites to warn teens of the dangers of e-cigarette use.

The FDA said: [2]

“We are committed to taking all necessary actions, such as inspections and advancing new policies, to prevent a new generation of kids from becoming addicted to tobacco products.”

Sources:

[1] The New York Times

[2] USA Today

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