On October 11th, the Food and Drug Administration issued a warning letter to Chinese vape product manufacturer, HelloCig, about the contents of their products. HelloCig has 15 days to respond to the letter. If not, they face further action “such as seizure or injunction,” the agency claims.
USA Today first reported the story Friday morning.
HelloCig released two vape juices: ‘E-Cialis’ and ‘E-Rimonabant.’ The vape juices contain ingredients found in erectile dysfunction prescription drugs. FDA lab analysis confirmed the presence of sildenafil and tadalafil in ‘E-Cialis.’ Sildenafil was present in ‘E-Rimonabant.’
“Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally,’ the FDA wrote in a press statement.
The FDA approved these ingredients for use in extant erectile dysfunction medication. However, HelloCig including them in their e-liquid classifies their products as ‘undeclared new drugs’ by the federal agency’s standards.
The agency closely monitors medicinal claims by consumer products such as vape juices, given contraindications of using them.
“These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors. These ingredients can be associated with significant safety issues and the risk of serious adverse events….[T]hey may interact with nitrates…used to treat, high blood pressure or heart disease, and can lower blood pressure to dangerous levels,” said officials.
In addition to the unlisted ingredients, the FDA writes that HelloCig mislabeled their products as approved by the agency. HelloCig claims, on their e-commerce site, products contain “pure nicotine.” Further, they write nicotine is an FDA approved product. Unfortunately, the verbiage reads at best like a poor translation. At worst, HelloCig actively broke FDA regulations.
Regardless, the Food and Drug Administration’s response was swift and serious. “Because these statements or representations on the website are directed to consumers and convey, mislead, or would mislead consumers into believing that the tobacco products are approved by FDA, they are in violation of section 301(tt) of the FD&C Act,” reads the press statement.
The warning letter comes at a particularly busy time for the FDA, with regard to regulating vape products. Over the last months, the administration has had to contend with things from worrisome levels of teen vape use to knock offs of US patented products.
420Cloud published an intensive guide on the strict and lengthy regulatory process vape manufacturers and retailers must follow to stay compliant.
US Food and Drug Administration: Warning Letters > HelloCig Electronic Technology Co., Ltd 10/11/18
US Food and Drug Administration: FDA In Brief: FDA warns company illegally selling e-liquid products intended for vaping that contain unapproved drugs for erectile dysfunction, weight loss and falsely claim to be FDA-approved