The FDA doesn’t know if flavored vaping chemicals are safe to breathe

Many e-cigarette flavorings have been approved for ingestion, but not inhalation. Now, a public health crisis looms

By Nicole Karlis

Senior Writer

Published June 7, 2018 6:00PM (EDT)

 (AP/Rich Pedroncelli)
(AP/Rich Pedroncelli)

Regulation of vapes and e-cigarettes has been in the news this week, after San Franciscans voted yes on a proposition that would prohibit the sale of flavored tobaccos — a category that includes menthol cigarettes, flavored hookah tobacco, infused cigars and flavored vaping liquids.

But while proponents of the ban succeeded by arguing that flavored tobacco products were a way for kids and teens to get hooked on tobacco products, a more looming public health issue lies in the mystery surrounding the safety of the flavoring chemicals inside e-cigarette liquids — many of which are billed by manufacturers as safe because the FDA has approved them for ingestion.

Yet no one knows for sure if you can breathe the same chemicals safely. Moreover, some common vape flavoring chemicals, including diacetyl, have been well-documented as causing chronic lung diseases.

Diacetyl was not originally supposed to be something that you smoke or breathe, but is commonly used to add flavor to food; if you've ever eaten microwave popcorn, you have probably consumed diacetyl.  Also known as 2,3-butanedione, diacetyl is approved by the U.S. Food and Drug Administration for ingestion, but there has not been an agency-approval for it to be inhaled. In fact, there have been multiple reports of people who breathed it contracting bronchiolitis obliterans — also known as “popcorn lung” — a lung disease that affects and inflames the lung’s small airways, or bronchioles. Those with the lung disease can experience shortness of breath, wheezing, and asthma-like symptoms.

The connection between diacetyl and “popcorn lung” came into the public eye in 2000 when an occupational medicine physician alerted the Missouri Department of Health and Senior Services about eight patients who had a fixed obstructive lung disease. The patients were former workers of a microwave popcorn factory; four of them went on lung transplant lists.

The Occupational Safety and Health Administration (OSHA) investigated cases of this popcorn lung and eventually released guidelines to deal with the chemical in factories. However, nothing has been done to regulate its usage in flavored tobacco products, despite evidence that the chemical is being used in flavored tobacco products.

In 2015, researchers at the Harvard T.H. Chan School of Public Health found that diacetyl was in 75 percent of the flavored electronic cigarettes and refill liquids they tested. In total, 51 types of flavored e-cigarettes and liquids sold by leading brands were tested for diacetyl, acetoin, and 2,3-pentanedione. This is a small sample size, considering there are nearly 7,000 varieties of flavored e-cigarettes and e-juice on the market and nearly 400 brands today — but the lack of knowledge of these products' ingredients and the safety of those ingredients could hint at a looming public health crisis. Now, some lung health advocates are alarmed that the FDA has failed to take action on the problem.

“The FDA has significant authority to oversee e-cigarettes and they are failing to use it,” Erika Sward, National Assistant Vice President of Advocacy at the American Lung Association, told Salon. “As a result it is the Wild Wild West, and you have retailers who are mixing liquids in their backrooms.”

“The American Lung Association is very concerned — about not just the chemical of diacetyl, but also the impact of other chemicals such as vegetable glycerin and propylene glycol, which are the base chemicals that are present in every e-liquid,” she added.

Vegetable glycerin and propylene glycol, similar to diacetyl, have been “generally recognized as safe” ("GRAS" in FDA lingo) by the FDA for ingestion — but not for inhalation, for obvious reasons. On popular vaping sites such as Vaping 360, the chemicals are often touted as safe due to its GRAS designation.

The FDA has been urged for the last several years to take immediate action and regulate e-cigarettes and flavored tobacco. Indeed, dozens of state attorney generals sent a letter to the FDA in 2015. The FDA told Salon they could not “accommodate” us with an interview for this story, but provided background information such as the agency’s advance notice of proposed rulemaking (ANPRM), which was issued in March 2018.

The purpose of the ANPRM was to initiate a public discussion around how the FDA should regulate flavored tobacco products, including menthol. As the FDA explained, the ANPRM was issued in order to call "upon all stakeholders to share data, research and information that can inform our process for examining the regulation of flavors in tobacco products." Yet this week the FDA appeared stalled in the regulatory process, and extended its commenting period from June to July 19, 2018.

The delay is disconcerting considering the National Youth Tobacco Survey (NYTS)  by the Centers for Disease Control and Prevention recently noted that e-cigarettes remain the most commonly used tobacco product among youth today. Moreover, a 2016 report from the U.S. surgeon general noted a 900 percent increase in e-cigarette use by high school students from 2011 to 2015.

Some e-cigarettes, including the Juul (pronounced like "jewel"), have gained a foothold among high schoolers, many of whom have reported harrowing stories of addiction. In April, The New York Times reported that the FDA was “cracking down” on Juuls, and noted that the agency had issued warning letters to 40 retailers accusing them of selling the USB drive-shaped vape pen to minors. Yet in the warning letters, there was no mention of concern about the chemicals used.

Tor Hoerman, an attorney who defends victims who have been exposed to diacetyl, says the FDA is capable of regulating these chemicals, but has failed to.

“They have the power to regulate,” Hoerman told Salon, adding that the lack of data can also be contributed to the rise in teens vaping. Sadly, Hoerman believes the repercussions of widespread inhalation of untested chemicals will be obvious when the public health effects are irreversible. “The human data is going to be young human data," he said.

In essence, this leaves any sort of regulation up to city and state policymakers — cities like San Francisco.

“Obviously one of the challenges that we have is right now is that the FDA has not reviewed any e-cigarettes, or the ingredients or chemicals in them,” Sward from the National Lung Association said. “My hope is now with San Francisco’s definitive result from the referendum that we will see more local communities turning to that, and hopefully that will spur the FDA to act across the country.”

 


By Nicole Karlis

Nicole Karlis is a senior writer at Salon, specializing in health and science. Tweet her @nicolekarlis.

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