October 24, 2019
“We’re taking today’s action because Eonsmoke has ignored the law by marketing dozens of unauthorized e-cigarette products. The marketing of illegal electronic nicotine delivery system products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing and has been fueled by flavored products that we know are appealing to kids. Companies are on notice – the FDA will not allow the proliferation of illegally marketed e-cigarettes or other tobacco products, to come at the expense of our children,” said Acting FDA Commissioner Ned Sharpless, M.D. “Preliminary data from the 2019 National Youth Tobacco Survey demonstrate a continued rise in the disturbing rates of youth e-cigarette use, especially through the use of kid-appealing flavors, which is why we announced plans to finalize a compliance policy that prioritizes the FDA’s enforcement of premarket authorization requirements for flavored e-cigarettes, including e-liquids in flavors such as mango, cotton candy, sour gummy worm and others that are so popular with kids. 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.”
Today, the U.S. Food and Drug Administration issued a warning letter to Eonsmoke LLC (Eonsmoke) of Clifton, New Jersey, notifying the company that nearly 100 flavored electronic nicotine delivery system (ENDS) products do not have the required marketing authorization, and thus cannot be legally sold in the United States, among other violations.
Eonsmoke sells ENDS products, such as flavored e-liquids, many of which are compatible with other popular ENDS devices, such as JUUL. This warning letter follows a previous letter from the FDA to Eonsmoke requesting additional information about whether Eonsmoke was illegally marketing new tobacco products without FDA authorization.
Specifically, the FDA notes in its warning letter today that Eonsmoke violated the Federal Food, Drug and Cosmetic Act (FD&C Act) by marketing new tobacco products without authorization, including e-liquids in flavors such as mango, cotton candy, sour gummy worm and others. These products were introduced or modified after August 8, 2016 – the effective date of the final rule that extended the FDA’s authority to all tobacco products. Any new tobacco product that does not meet the FD&C Act premarket requirements is adulterated and/or misbranded and may not be legally marketed without authorization from the FDA. The agency has several tools to enforce the requirements of the FD&C Act and regulations, including pursuing administrative actions such as civil money penalty complaints (fines) or judicial actions such as seizures or injunctions.
The warning letter also cites the company for marketing unauthorized modified risk tobacco products with labeling or advertising that represents explicitly and/or implicitly that the products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products and/or do not contain or are free of a substance. For example, the company’s website included the claim: “Eonsmoke electronic cigarettes provide you with a premium vaping experience without the thousands of harmful chemicals and additives often found in tobacco cigarettes.” These types of claims require review by the agency through the modified risk tobacco product pathway, which requires the company to submit evidence to support its claims.
Additionally, the warning letter notes that the company was advertising products online and through social media with advertisements, including social media posts on behalf of Eonsmoke by well-known influencers, that do not include the required nicotine warning statement:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
The FDA’s letter also informs Eonsmoke that it failed to provide the FDA with the required ingredient listing information for its products.
The FDA has requested that Eonsmoke provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the FD&C Act. Failure to ensure compliance with FD&C Act may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure and/or injunction.
As part of the agency’s Youth Tobacco Prevention Plan, the FDA continues to work on all fronts to tackle the troubling epidemic of youth e-cigarette use through all available regulatory tools. This includes taking action against manufacturers and retailers who illegally market or sell these products to minors, educating youth about the dangers of e-cigarettes, and implementing the policies necessary to keep them out of the hands of America’s kids.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.