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The Food and Drug Administration on Thursday appealed to an e-cigarette company to worry that its products contain unapproved drugs meant to treat erectile dysfunction.
The FDA said the Chinese company HelloCig Electronic Technology Co., Ltd. had 15 days to respond to the accusation that two of their fluid-containing fluid products sold in the United States contained unapproved drugs 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 announced in a press release. "These ingredients can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with the nitrates found in some prescription medications used to treat high blood pressure or heart disease and can lower blood pressure to dangerous levels. "
Both Cialis and Viagra are approved by the FDA, but the drugs contained in these drugs are not approved by the agency to be added to the liquids of the electronic cigarette.
HelloCig has used bottles of Cialis and pills images in its commercials, suggesting that the e-liquid could treat erectile dysfunction. HelloCig also announced Acomplia bottles and pills, an unapproved anti-obesity drug, the FDA announced.
Administration Commissioner Scott Gottlieb, MD, said he was calling the vaping company because these ingredients are potentially dangerous for younger consumers.
"This action is part of the FDA's broader efforts to regulate the safety of vaping products and to combat misleading claims and illegal and dangerous e-liquids that could attract young people or people." to put consumers at risk, "he said.
"There are no e-liquid products approved to contain prescription drugs or any other medications that require the supervision of a physician," continued Gottlieb. "Prescription drugs are carefully evaluated and labeled to reflect the risks of the drugs and their potential interactions with other drugs, and vaping the active ingredients of the drug is an ineffective and potentially dangerous delivery route."
The FDA has sent a letter of warning to the company, listing its grievances and demanding an answer within 15 days.
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