FDA Issues Warning Letter to Vaping Manufacturer Eonsmoke LLC

FDA Issues Warning Letter to Vaping Manufacturer Eonsmoke LLC

The U.S. Food and Drug Administration (FDA) has issued a warning letter to vaping company Eonsmoke, LLC, accusing it of ignoring the law and illegally marketing dozens of e-cigarette products. The FDA is calling on Eonsmoke, LLC to remove nearly 100 different flavored vaping products from the market or face consequences.

Naming the ongoing rise of the number of youth who using e-cigarettes and vaping products, the FDA is calling out what it views as “irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing.” The FDA’s acting commissioner Ned Sharpless, M.D. states that his agency will not allow illegally marketed e-cigarettes or other tobacco products to negatively impact children.

“We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren’t being marketed or sold to kids. Today’s action makes clear that we will continue to keep a close watch on companies and take swift steps when violations are found,” stated Sharpless.

The FDA takes issue that Eonsmoke’s products are being sold and marketed without the required marketing authorization and says because of this, the company’s products can’t be legally sold in the U.S. This is an issue many vaping manufacturers are facing as the FDA begins to push the compliance requirement of having pre-market authorization before selling and marketing covered tobacco products in the U.S. Since Eonsmoke’s products were introduced after Aug. 8, 2016 when the Deeming Rule when into effect, all of the company’s products are viewed as new and must gain authorization from the FDA before being sold and distributed in the U.S., per the Federal Food, Drug and Cosmetic Act (FD&C Act).

Another issue the FDA took with Eonsmoke is the company illegally using modified risk claims for its products that imply their vaping products present a lower risk of tobacco-related disease and are less harmful than other tobacco products. One statement the FDA especially took issue with is one that was displayed on its website that stated, “Eonsmoke electronic cigarettes provide you with a premium vaping experience without the thousands of harmful chemicals and additives often found in tobacco cigarettes.” In order to use this claim in its marketing, Eonsmoke must go through the modified risk application process, which requires the company to submit evidence to support its claim. As of now, the company has not yet submitted a modified risk application or supporting evidence.

The FDA also examined how Eonsmoke marketed its products online and used social media influencers. The use of influencers and social media to market e-cigarettes has come up in the past few months with the FDA reiterating that companies must use proper nicotine warning statements in its social media posts [read more here].

Eonsmoke must provide the FDA with the required ingredient listing information for its products and must provide a written response to the FDA within 15 working days to describe its corrective actions and its plan for maintaining compliance with the FD&C Act. Failure to comply could lead to civil penalties, seizure and/or injunction.

To read the warning letter in full, click here.