Mon. Nov 28th, 2022
e-cigarette co.  put Viagra, Cialis in vape liquids - the FDA is crazy

The U.S. Food and Drug Administration made it clear on Thursday, Oct. 11 that it has a major problem with an electronic cigarette seller who illegally pumped prescription drugs for erectile dysfunction into unapproved e-liquid products intended for vaping.

The stubborn company, HelloCig Electronic Technology Co. Ltd, even advertised the vape liquids with labels and branded images for drugs. For example, it sold one of the vape liquids as “E-Cialis HelloCig E-Liquid” alongside an image of a bottle and tablets of Eli Lilly’s erectile dysfunction drug Cialis. It also sold a product branded as an anti-obesity drug that had been withdrawn from the market in Europe for causing psychiatric disorders. The e-liquid actually contained the erectile dysfunction drug in Viagra, the FDA found.

In other cases, the company falsely claimed that e-liquid products were “FDA-approved product”[s] with FDA.”

The beating mad agency issued a stern warning and vigorously threatened “civil fines, criminal charges, seizure and/or injunction” if HelloCig did not immediately withdraw its products from the market. The company has 15 days to respond.

FDA Commissioner Scott Gottlieb criticized the company in a statement, saying:

There are no e-liquid products approved to contain prescription drugs or other medications that require physician supervision. Prescription drugs are carefully evaluated and labeled to reflect the risks of the drugs and their potential interactions with other drugs, and vaping active drug ingredients is an ineffective route of administration and can be dangerous. There are no e-liquids containing prescription drugs that have been proven to be safe or effective through this route of administration.

The FDA’s warning is part of an ongoing effort to debunk misleading and illegal claims on vaping products. The agency’s main goal is to block products that specifically entice young people to try addictive nicotine-containing products. Last month, Gottlieb stated that e-cigarette use among teens has “reached no less than epidemic growth.”

“I use the word epidemic with great concern,” he wrote in a statement at the time. “E-cigarettes have become an almost ubiquitous – and dangerous – trend among teens. The disturbing and accelerating use trajectory we see in childhood, and the resulting path to addiction, must end. It’s just unbearable. I will be clear. The FDA will not tolerate an entire generation of young people becoming addicted to nicotine as a compromise to give adults unfettered access to the same products.”

As such, the agency has tackled the e-cigarette companies and all questionable tactics. Most notably, the agency seized more than a thousand sales and marketing records from popular e-cigarette maker Juul Labs during an unscheduled inspection a few weeks ago. Juul e-cigarettes resemble USB sticks and have been extremely popular, especially among teenagers. They currently make up the lion’s share of the e-cigarette market. The FDA’s primary concern is advertising and flavoring for e-liquids, such as candy and fruit flavors, designed to hook young people.

With that focus, the FDA conducted lab analysis on HelloCig’s e-liquids, finding products containing tadalafil (Cialis) and/or sildenafil (Viagra). The FDA also scrutinized the company’s product called “E-Rimonabant HelloCig E-Liquid,” which was marketed alongside an image of a bottle and tablets of Acomplia, an anti-obesity drug developed by Sanofi-Aventis. . Acomplia was never approved by the FDA, but was previously approved in Europe in 2006. However, it was withdrawn from the market in 2008 after it was found to significantly increase the risk of psychiatric disorders. HelloCig’s e-liquid did not contain rimonabant (Acomplia), but did contain undeclared sildenafil, the FDA found.

By akfire1

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