The Food and Drug Administration (FDA), an agency of the US Department of Health and Human Services, has sent a warning letter to the China-based e-cigarette supplier HelloCig, which purportedly sells vape juice that contains prescription drugs used to treat erectile dysfunction.
According to the watchdog, HelloCig sells two e-cigarette liquids, one containing an ingredient active in Cialis and the other an ingredient for Viagra. Although both Cialis and Viagra are FDA-approved prescription drugs, they are not approved to be added to e-liquid, the FDA claims.
FDA warns HelloCig Electronic Technology Co. Ltd for the illegal sale of two unapproved new drug products and false FDA-approved marketing claims for several other e-liquids. https://t.co/6YyFmMoMj2
— FDA Tobacco (@FDATobacco) 11 октября 2018 г.
The FDA also warned that these ingredients, sildenafil and tadalafil, may interact with some prescription drugs used to treat high blood pressure or heart disease, and can lower blood pressure to dangerous levels.
"These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally. In addition, the company is marketing other e-liquids used in e-cigarettes in ways that convey and mislead consumers into believing that the FDA has approved these tobacco products, when it has not," the agency said in an online statement.
The FDA dug into HelloCig's website to find out that the company has unabashedly advertised its e-cigarette liquids alongside labels and images using drug brand names. For instance, it claims that an advertisement for "E-Cialis HelloCig E-Liquid" featured an image of a Cialis bottle and tablets and a "partially undressed couple" embracing, accompanied by the caption, "WOOOOW, Have you tried our E-Cialis? It is amazing LOL."
HelloCig was given a 15-day ultimatum to respond to the FDA's concerns; it risks facing further action such as seizure or injunction if it fails to meet the request.
"There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor's supervision," FDA chief Scott Gottlieb stated. "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."
