Amid concerns of ecigs health issues, the FDA recently warned Eonsmoke LLC that it has been selling tobacco products without proper authorization.
On Oct. 24, the U.S. Food and Drug Administration (FDA) sent a warning letter to Eonsmoke LLC, a New Jersey-based vaping company. According to the FDA, almost 100 of the company’s products have been marketed unlawfully because they lack the necessary marketing authorization from the agency.
The products were reportedly introduced to the marketed or modified after the FDA took authority over tobacco product regulation in 2016. Because the products do not meet the Food, Drug and Cosmetic Act premarket requirements, the company is unable to market them without FDA approval, according to the letter.
The agency also took issue with some of the company’s advertisements. These labels and ads reportedly claimed that “Eonsmoke electronic cigarettes provide you with a premium vaping experience without the thousands of harmful chemicals and additives often found in tobacco cigarettes.” The FDA is reportedly required to review these statements since they indicate the Eonsmoke vaping products to be less harmful than traditional tobacco products such as cigarettes.
“We’re taking today’s action because Eonsmoke has ignored the law by marketing dozens of unauthorized e-cigarette products,” acting FDA Commissioner Ned Sharpless said in a press release. “Companies are on notice — the FDA will not allow the proliferation of illegally
Eonsmoke reportedly has 15 business days to comply with the FDA warning. If it fails to do so, they may face fines and other penalties.
According to a statement from the company, the FDA’s notice is being reviewed and changes will be implemented.
“Our company takes this matter and the national vaping crisis very seriously. We will comply with all FDA requests in the time table allotted,” Eonsmoke CEO Michael Tolmach said in the statement.
“We’ve shut down our entire marketing campaign earlier this year including closing our Instagram, Facebook, and Twitter pages. We look forward to complying and interacting with the FDA over the coming weeks and resolving this crisis.”
Recent Ecigs Health Issues
E-cigarette safety has been highly contested recently amidst thousands of patients falling sick with an unknown vaping-related illness.
As of Nov. 5, there have reportedly been 2,051 confirmed cases of vaping associated lung injury. There have reportedly been 39 deaths so far, with more deaths under investigation by the CDC.
On Nov. 8, the CDC reached a breakthrough when laboratory testing of fluid collected from the lungs of 29 patients who developed ecigs health issues showed the presence of vitamin E acetate.
This is reportedly the first time that the agency detected a “chemical of concern” in biological samples during their investigation. This development will help the CDC and other regulators take steps to keep people safe and keep dangerous products off the market.
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