[ad_1]
The ongoing war against the vaping of the Food and Drug Administration has perhaps taken its strangest turn to date. On Thursday, the agency sent a warning letter to a company that had illegally extorted drugs in its vaping fluids with drugs for erectile dysfunction.
The Chinese company in question, HelloCig Electronic Technology Co. Ltd., did not fear for its project. One product, the "E-Cialis HelloCig E-Liquid", was tested by the FDA and contained sildenafil and tadalafil, the active ingredients in Viagra and Cialis branded medicines, respectively. Another product, "E-Rimonabant HelloCig E-Liquid", has been marketed as containing the anti-obesity drug rimonabant. But the FDA found that it also contained sildenafil.
"There are no electronic products approved to contain prescription drugs or any other medications that require the supervision of a physician," said FDA chief Scott Gottlieb in a statement announcing the warning letter. "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 electronic liquids that are likely to attract young people or consumers." put consumers at risk. "
The question of how these drugs affect the body in case of vaping is an open question because there is no real research on the subject. But even when they are used safely, medications such as sildenafil may pose a risk to the heart, blood pressure and vision. The risks of serious side effects increase only when they are mixed with other common prescription medications, such as nitrates.
Not to mention, one can not help grinding his teeth to the surprise of some users hoping to lose weight if they had taken a breath of sildenafil inadvertently.
The FDA letter sent to the company gives her a 15-day ultimatum to respond to the agency, detailing how she plans to repair her damage. Ignoring the FDA's warning may result in more aggressive actions, such as a seizure of company products by law enforcement officials or a legal injunction that would cause cease operations.
But the FDA does not stop there. On Friday, the agency also sent letters to 21 companies that manufacture and import electronic cigarette products, asking them to provide them with any information that would help them decide whether certain products – more than 40 in total – are illegally marketed , especially among young people. children and adolescents. These measures follow a surprise FDA inspection of the offices of the large JUUL vaping company in San Francisco last month. As part of this inspection, the agency obtained thousands of documents on JUUL's marketing practices.
"If products are traded illegally and outside the FDA's compliance policy, we will act to remove them," Gottlieb said Friday. "This includes revising our compliance policy that allowed some electronic cigarettes, including flavored cigarettes, to stay on the market until 2022, while their manufacturers submit prior authorization requests to commercialization."
It should be noted, according to a recently published study, that the agency often refuses to use its authority to recall supplements containing prescription drugs, including sildenafil.
[FDA via The Verge]Source link
