A company in China advertises that it has Cialis and other drugs in its e-cig liquids. Health advocates want a crackdown.
A popular trend the U.S. Food and Drug Administration (FDA) has termed an “epidemic” took an odd turn recently — but public health advocates weren’t surprised.
E-cigarettes have grown exponentially in popularity in recent years with little regulation to slow them down.
That’s why, the advocates say, a little-known company has been able to include prescription drugs in the liquid that users of its e-cigarettes inhale.
That case came to light when officials at the FDA sent the company a letter last week.
Advocates say it shows the dangers of vaping’s booming growth and the need for more regulation of the industry.
The fact we have reached this point, however, doesn’t surprise them.
“Some have equated it to a wild west where really anything goes and unfortunately that’s closer to the truth than people realize,” Erika Sward, assistant vice president of National Advocacy for the American Lung Association, told Healthline.
HelloCig, which calls itself a maker and retailer of e-cigarettes “headquartered in the beautiful City of China,” has been including the anti-erectile dysfunction drug Cialis in some of its products, FDA officials said.
It said other products from the company include the banned anti-obesity drug Acomplia.
The company isn’t shy about those added ingredients.
It advertises the products with photos of the prescription bottles.
And it says, falsely, its products are FDA approved.
All of these actions are violations of U.S. law.
All the products, FDA officials say, are shipped to the United States, where people without prescriptions for those medications might “vape” the drugs and face serious health risks.
An obscure company selling shady e-cigarette products might sound like a case of a single bad actor — and one that few reasonable people would fall for.
But advocates say the situation is indicative of the broader state of the e-cigarette industry.
“Given how out of control this industry has been, I guess it was just a matter of time before we saw something like this,” Dennis Henigan, vice president of legal and regulatory affairs at the Campaign for Tobacco-Free Kids, told Healthline.
The nature of e-cigarettes’ design opens them up to this kind of addition of unexpected ingredients.
“It’s one of the unique aspects of e-cigarettes that they can be a mechanism for all kinds of substances into the body,” Henigan said.
He noted the devices are often used with cannabis.
It’s also why so many flavors, and less tasty things, can be included.
In the darker corners of the web, you can even buy e-cigarettes said to contain cocaine, ecstasy, and other illegal drugs.
“Surveys have shown kids often don’t realize they have nicotine in them,” Henigan said.
Among high school students, e-cigarette use jumped 75 percent in the past year, Henigan said, and 20 percent of high schoolers say they have used an e-cigarette.
A 2016 report found a 900 percent rise between 2011 and 2015 among high school students.
It’s a rapid spread for a product that only became widely available less than a decade ago.
One company, Juul, accounts for more than half of e-cigarette sales in the United States, despite only being around since 2015.
That troubles Henigan and other advocates because, in addition to its addictive properties, nicotine can be damaging for young, developing brains.
And even though e-cigarettes are safer in other ways than traditional cigarettes, they can act as a “gateway” drug.
Some studies have found teens who vape are more likely to take up smoking.
This has led FDA Commissioner Scott Gottlieb to repeatedly call the spread in popularity of e-cigarettes an epidemic.
Recently, his agency has been taking more actions like the letter to HelloCig.
In that case, the company has until Nov. 1 to fix the mislabeling, misuse, and other violations, or it may face possible fines, criminal prosecution, or other penalties, including the seizure or refusal of entry to imported products.
Multiple emails to and attempts to contact HelloCig through its website’s chatbot went unanswered.
An FDA spokesman said he wasn’t able to comment on ongoing compliance matters.
A spokesman for Eli Lilly, which makes Cialis said, “Counterfeit drugs pose a very real risk to patients, and patient safety is Lilly’s number one concern.”
Other recent FDA actions have included warning letters and a campaign to draw attention to flavors of e-cigarettes that appear to be targeted to kids.
Those include such products that resemble Tree Top juice boxes, Warheads candy, and Golden Oreo cookies.
The rapid expansion of products means there’s something for everyone, and that’s a problem, said Sward.
“While some might have unapproved prescription drugs in their liquids, others have other chemicals that aren’t even known,” the American Lung Association spokeswoman said.
Sward said there are now about 500 brands and 7,000 flavors on the market, “and we don’t really know what’s in them.”
She blames the FDA for that.
Despite its rhetoric and recent initiatives, Sward said she doesn’t see meaningful regulatory action from the agency.
To her, that lack of action is precisely why products like a vape pen that allows you to inhale chemicals found in a pill meant to treat erectile dysfunction can end up here.
But within a year, after a new administration took over in Washington, it delayed enforcement of parts of those new rules.
That effectively meant those thousands of e-cigarette products could continue to be sold without the agency first reviewing their safety.
The deadline by which companies would need to file applications to have their products approved in order to remain on shelves was pushed back to 2022.
Even then, the products will remain available while the reviews are completed.
Several health groups, including the American Lung Association, sued in March to challenge those delays.
The FDA appears to be starting to revisit that decision, given its own conclusions that there’s an epidemic happening among youth.
The FDA’s Gottlieb has said that, “in view of the accelerating use among youth, we’re actively considering whether we will enforce the premarket review provision earlier.”
But that delay has opened the door to things like Cialis in vaping liquid, Sward contends.
“This situation speaks to the need for real and meaningful oversight by the FDA of all e-cigarettes,” she said. “This manufacturer got caught. We don’t know about what people who are maybe doing similar things are up to and who are not being caught.”