The Food and Drug Administration called out an e-cigarette company Thursday over concerns that its products contain unapproved drugs meant to treat erectile dysfunction.
The FDA said the China-based HelloCig Electronic Technology Co., Ltd. has 15 days to respond to the charge that two of their e-liquid products sold in the U.S. contain unapproved drugs that are active in Viagra and Cialis.
One of the products was even called ‘E-Cialis.’
“E-Cialis HelloCig E-Liquid” contained sildenafil and tadalafil and “E-Rimonabant HelloCig E-Liquid” contained sildenafil, the FDA said in its press release. “These ingredients can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs used to treat, high blood pressure or heart disease, and can lower blood pressure to dangerous levels.”
Both Cialis and Viagra are FDA-approved but the drugs contained with in those medicinces are not approved by the agency to be added to e-cigarette liquids.
HelloCig used Cialis bottles and pill imagery in their ads, implying the e-liquid could treat erectile dysfunction. HelloCig also advertised Acomplia bottles and pills, which is a unapproved anti-obesity drug, the FDA said.
The administration’s commissioner, Scott Gottlieb, M.D., said they were calling out the vaping company because including these ingredients are potentially dangerous to younger consumers.
“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.” he said.
“There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor’s supervision,” Gottlieb continued. “Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous.”
The FDA sent a warning letter to the company, listing its grievances and demanding a response within 15 days.