Don’t Use THC Vapes, Says FDA, As Lung Injury Toll Tops 1000

The US Food and Drug Administration is strengthening its consumer warnings for vape products in light of the vaping-related lung disease outbreak currently rocking the United States.

The FDA is now advising consumers to completely avoid vape products that contain tetrahydrocannabinol (THC) – whether bought from legal dispensaries or “obtained off the street.” Consumers are also being advised to avoid all vape products originating from illicit or unknown sources, regardless of whether they contain nicotine salts, tobacco, or THC.

"We're strengthening our message to the public in an updated consumer alert stating that they should not use vaping products containing THC, the primary psychoactive component of the cannabis plant,” said FDA Acting Commissioner Dr Ned Sharpless in a statement, released Friday.

"Additionally, consumers who choose to use any vaping products should not modify or add any substances such as THC or other oils to products purchased in stores and should not purchase any vaping products, including those containing THC, off the street or from other illicit channels," he continued.

“At this time, the FDA does not have enough data to identify the cause, or causes, of the lung injuries in these cases,” Sharpless added. "While no one compound or ingredient has emerged as a singular culprit, we do know that THC is present in most of the samples being tested. Because of this, the agency believes it is prudent to stop using vaping products that contain THC or that have had any substances added to them, including those purchased from retail establishments.”

Over 1,000 cases of vaping-related lung injury seen so far

So far there have been 1,080 cases of lung injury linked to the mystery vaping-related lung disease reported to the US Centers for Disease Control and Prevention (CDC). These cases span 48 states and the US Virgin Islands.

The number of fatal cases nationwide has now risen to twenty-two across nineteen states, as officials from the Massachusetts Department of Health on Monday confirmed the passing of a Hampshire County woman in her 60s from vaping-relating lung injuries.

"We now have information for 578 patients with information on substances used in e-cigarette or vaping products in the three months before symptom onset,” explained the CDC’s Principal Deputy Director, Dr Anne Schuchat, during a briefing with reporters.

At present, the exact cause of the illness remains unknown, but the CDC has “found that about 78 percent reported using THC containing products," Schuchat said. "This is a critical issue.”

The FDA has opened a criminal investigation into the outbreak of the vaping illness, which will run parallel to its ongoing efforts to gather data and address the cause, or causes, of the lung injuries.

Suspected causes

While the FDA and CDC both stress that the underlying cause behind the lung illnesses has yet to be identified, there are a number of suspects that are under scrutiny.

The prime suspect thus far is vitamin E acetate, a diluent thickener known to be used in illicit market THC vape products. While vitamin E acetate is used safely in the cosmetics industry for a variety of topicals and creams, it has never before been considered for use as an inhaled substance, and so its inhalation toxicity and effects are unknown.

The New York State Department of Health has already publicly identified vitamin E acetate as the key focus of its own investigation, but a representative of the FDA’s Center for Tobacco Products pushed back following this announcement, saying that multiple chemicals common to vaping liquids were still under active investigation by the agency.

Others have suggested that poor quality vape cartridge components may be to blame, with increasing tariffs leading companies to cut corners during production.

Vape companies facing regulatory backlash

The extent of the vaping-related lung injuries has prompted many lawmakers to bring in, or to consider, further regulatory restrictions on the vape industry in response to the illness.

At the federal level, the Trump administration is finalizing a ban on flavored e-cigarette products, which the president believes will help to deter teenagers and young adults from taking up vaping in the first place.

"We can’t allow people to get sick and we can’t have our youth be so affected,” said President Trump during an Oval Office meeting with the Health and Human Services Secretary and acting FDA Commissioner. "People are dying from vaping, so we’re looking at it very closely.”

The federal ban is already attracting resistance from some conservative groups and Republican lawmakers, who say that the ban is an example of the administrative overreach and could severely affect small businesses, which they say would be a violation of core Republican free market principles.

At the state level, Massachusetts’ governor, Charlie Baker, has already declared a public emergency and called for a four-month ban on the sale of all e-cigarette and vape products in the state. Last week, a federal judge upheld the governor’s ban, stating that the risk to public health outweighed the potential economic consequences after local vape shops mounted a legal challenge to the ban. Pending any further legal challenges, the ban will run through January 25, 2020.

Elsewhere, Michigan has brought in its own state-level ban on flavored vaping products, in a similar manner to the federal ban proposed by the Trump administration.

The ban temporarily prohibits retailers from selling all vape products that aren’t tobacco flavored until March 30, 2020. The ban extends to menthol-flavored vapes, as well as those favored to taste like food or drink or spices. It also introduces several restrictions on vape product advertising. 

The Michigan ban is currently facing two lawsuits from the owners of two e-cigarette and vape product retail shops. Two Republican lawmakers have also introduced a bill that would stop the ban from affecting flavored vape products that have a nicotine content of 2 percent or less.