The FDA Files Vape Lawsuit Against Flavored E-Cigarettes
The FDA is currently battling a new flavored e-cigarette on the market, and it’s looking to get its hands on it. Juul, Triton, StemStix, and others have all been accused of aggressive marketing. This lawsuit comes on the heels of a warning letter from the FDA about flavored e-cigarettes. Here’s a look at some of the facts surrounding the lawsuit and what might happen.
Juul’s aggressive marketing of flavored e-cigarettes
The FDA is investigating Juul’s aggressive marketing of flavored electronic cigarettes. The e-cigarette company has made a habit of sending representatives to high schools and colleges before the spring 2018 vaping ban went into effect. These representatives promoted Juuls as safer than traditional cigarettes and compared them to the iPhone. But despite the law’s intention to protect youth, it appears that Juul has done the opposite. A recent study revealed that Juul’s marketing campaign had encouraged teens to continue using cigarettes despite the ban.
The FDA has requested documents from Juul Labs to assess the company’s aggressive marketing of flavored e-cigarettes. The agency also conducted inspections of contract manufacturing facilities and the company’s corporate headquarters. A court could require Juul to provide documentation and submit an explanation of its marketing methods. The company has not yet responded to the FDA’s requests for further information.
Triton Distribution, a company in the vapor industry, is challenging the U.S. Food and Drug Administration (FDA). In a recent court case, Triton’s lawyer argued that the agency did not adequately consider the marketing plan and related issues in its MDO. The FDA failed to consider surveys, evidence that flavored e-cigarettes could have health benefits, and Triton’s statements about the benefits of flavored e-cigarettes.
The FDA’s full stay does not mean that Triton’s products will be allowed to be marketed, however. Unlike Turning Point Brands, Triton has not filed a motion for a full rescission of the marketing denial order. Nevertheless, the case bodes well for the company in future battles with the FDA. However, the company has until Oct. 2021 to submit a new marketing plan to the FDA.
Earlier this year, the FDA issued a warning letter to stem juice makers, telling them to stop their marketing practices or risk losing their license to sell the products. The company, StemStix, was also accused of making misleading claims on its website. But the company’s chief scientific officer, Dr. Sanjay Dhar, is quick to explain that his job is to guide the company with biosciences and regulatory requirements.
In response, the FDA committed to reviewing the remaining products. Juul’s marketing is also under scrutiny from the government, which has said it will continue to expedite the review of its products. Juul, for example, owns three brands, including Vuse and blu, and is the industry leader. The company said it “respects” the role of the FDA in the review process.
StemStix’s warning letter to FDA
The FDA’s latest warning letter to stem juice companies, stem six, reveals that there is no guarantee that its products can treat diseases. The letter calls for drug approval from the agency. The company’s chief scientific officer, Sanjay Dhar, says his job is to lead the company through bioscience and regulatory requirements. He holds a Ph.D. in Parasitology from the Indian Veterinary Research Institute.
In addition to the warning letter on stem cell therapy products, FDA enforcement actions were ongoing during the COVID-19 pandemic. The agency issued a substantial number of warning letters citing quality issues with drugs and biologics manufactured by 503A-compliant companies. These warning letters, which often address specific CGMP violations, demonstrate that a product is not meeting regulatory requirements. This is why the agency is issuing such substantial warning letters.