The FDA sent a warning letter yesterday to a Chinese company selling e-liquids that violate multiple sections of the federal Food, Drug, and Cosmetic Act. In a statement and a series of tweets, FDA Commissioner Scott Gottlieb portrayed the warning as part of the agency’s efforts to reign in the U.S. vaping industry.
“This action is part of FDA’s broader effort to regulate the safety of vaping products, and crack down on misleading claims and illegal and dangerous e-liquids that may entice youth or put consumers at risk,” said Gottlieb in a statement.
The cited commerce site has been given 15 working days to respond to the FDA’s warning letter. The agency says the company sells e-liquid containing prescription drugs intended to treat erectile dysfunction and obesity. Such products could be very dangerous, especially the ED medication, which can interact with nitrate drugs to cause a rapid drop in blood pressure that could be life-threatening.
“Failure to correct violations may result in further action such as seizure or injunction,” says the FDA press release.
But the sanctioned company is not American, and doesn’t appear to have any retail or wholesale presence in the United States. In fact, the FDA warning letter was sent only to an email address, and Vaping360’s research indicates that the company’s sales seem to be conducted exclusively by mail from China. We could find no U.S. distributor or online evidence of any domestic sales.
That may make the FDA’s announcement and Gottlieb’s statement useful as a way of promoting their anti-vaping public relations campaign. Unfortunately, it also publicizes what had been a virtually unknown company that sells some truly dangerous products. The FDA action may cause serious harm by making people aware of the obscure company’s existence.
The company is located in Shanghai, according to its website and Facebook page, although it does offer worldwide shipping. Even though the company has had a website since at least 2008, there is not a single mention of it on E-Cigarette Forum (ECF), a user forum that has hosted discussions about virtually every vaping brand in history.
The company sells a weird variety of e-liquid and related products. In addition to the products that apparently contain actual prescription drugs — which have pictures of Cialis and Acomplia tablets next to the liquid bottles — the cited company has a lot of simple, single-flavor e-liquid, as was common in the early days of vaping.
They also sell some flavors that use American e-liquid companies’ trademarked names, from manufacturers like Five Pawns, Cosmic Fog, Space Jam, and Halo. Among the flavor names are Grandmaster, Castle Long, Andromeda, and Tribeca. They also have an e-liquid called — no kidding — E-Marijuana. Those products represent intellectual property theft, and the e-marijuana is silly, but the company also sells some downright dangerous stuff.
The site offers high-strength DIY nicotine in containers that look like e-liquid bottles. Both 800 mg/mL and what the company describes as “pure nicotine” (1,000 mg/mL) are available in sizes from 5 mL to 1 liter. The 5, 10 and 30 mL bottles could easily be mistaken for e-liquid and accidentally vaped, with potentially deadly consequences.
A 10 mL bottle of 1,000 mg/mL (100%) nicotine contains 10-20 times the lethal dose for an adult. Pure nicotine is usually sold directly only to e-liquid manufacturers, who dilute it with PG and VG to make e-liquid. It must be handled only with safety equipment like protective glasses, masks and gloves, and in rooms with controlled ventilation. American DIY suppliers don’t sell nicotine in concentrations higher than 100 mg/mL (10%) to the retail market.
The FDA did not cite the pure nicotine in its warning letter. Even if the company removes the Cialis product, the most dangerous products on its site will remain available.
The cited company is clearly not a responsible vape vendor, and not only for the reasons the FDA cites in its warning letter. The company is also not part of the U.S. vaping industry that the FDA regulates — and it’s certainly not representative in any way of the domestic industry. Nobody in the American industry supports the practices that earned this Chinese company the FDA’s attention.
The FDA publicity surrounding this warning serves no real purpose. It gets Gottlieb and his agency more attention in their effort to demonize the American vaping industry, but it does nothing to actually prevent this irresponsible Chinese business from selling dangerous products to American customers and others around the world. In fact it will probably increase their sales, by providing a boost of name recognition and curiosity that the company could never have generated on its own.
We asked the FDA if it acquired the tested samples in a U.S. sales channel, if the FDA is aware of the company’s products being sold in the U.S., and if the agency learned about the company through consumer complaints, or if the regulators proactively searched online for dangerous products that violate U.S law. The agency hasn’t replied with answers yet, about 20 hours later. [Editors note: the FDA never replied to our inquiry.]
The FDA issues warning letters all the time for various violations of its rules, and they usually are not accompanied by press releases, let alone statements and tweets from the agency’s highly visible commissioner. The publicity given to this irresponsible vaping industry outlier was calculated and intentional, and that makes the FDA itself an irresponsible actor.
If any lives are damaged or lost because of products bought from this previously unknown company, the responsibility will lie with the FDA. Because of Scott Gottlieb’s desire to score brownie points with anti-vaping politicians and tobacco control groups, the agency has brought attention to a company that deserves none.