FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal

Summary

Letters to four companies follow initial request to JUUL Labs as part of an ongoing effort to address youth use under the agency’s Youth Tobacco Prevention Plan

Release

June 21, 2018: Letters were also issued in late May to Myle Vape Inc. regarding Myle Products, and to MMS ECVD LLC regarding Bo Starter Kit, to reflect additional relevant companies in the manufacturing and distribution chain.

Today, the U.S. Food and Drug Administration continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette manufacturers requiring them to submit important documents to better understand the youth the appeal to these products.

With this information, the agency will further examine marketing practices, and the youth use and appeal of these types of tobacco products. The new letters follow a similar request that the agency sent to JUUL Labs Inc. last month. These actions are part of the FDA’s Youth Tobacco Prevention Plan, which aims to protect youth from the dangers of nicotine and tobacco products, especially e-cigarettes and other electronic nicotine delivery systems (ENDS). “Too many kids continue to experiment with e-cigarette and vaping products, putting them at risk for developing a lifelong nicotine addiction. These products should never be marketed to, sold to, or used by kids and it’s critical that we take aggressive steps to address the youth use of these products. This includes taking a hard look at whether certain design features and product marketing practices are fueling the youth use of such products,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll explore all of our regulatory options, including enforcement actions, based on what we learn from the information these manufacturers are required to provide. No child should be using any tobacco product. We’ll continue to take vigorous steps under our Youth Tobacco Prevention Plan, using the full scope of our authorities, to target youth access to, and appeal to, these products. Our top priority is to prevent kids from getting hooked on nicotine.”

The companies and the specific products receiving the official requests for information under section 904(b) of the Family Smoking Prevention and Tobacco Control Act are J Well, of Paris, France, for Bo Starter Kit; YGT Investment LLC and 7 Daze LLC, of Baldwin Park, California, for Zoor Kit; Liquid Filling Solutions LLC, of King of Prussia, Pennsylvania, for Myle Products; and SVR Inc., of Las Vegas, for SMPO Kit.

The FDA selected these companies based on product attributes that overlap with those of JUUL, including:

• The use of e-liquids that contain nicotine salts with corresponding high nicotine concentration;
• A small size makes these products easily concealable; and
• Product design features that are intuitive, even for novice users.

The information the FDA is requesting includes but is not limited to: documents related to product marketing, documents related to research on product design (as it may relate to the appeal or addictive potential for youth, youth-related adverse experiences), and consumer complaints associated with the products. The companies have until July 12, 2018, to respond to the agency.

Failure to provide the information is a violation of the law and subject to regulatory and enforcement action by the FDA. The agency also may send letters to additional manufacturers of products that raise similar concerns about youth use.

In April, as a new part of its comprehensive plan on nicotine and tobacco regulation, the FDA announced a Youth Tobacco Prevention Plan. The plan began with a nationwide blitz of brick-and-mortar and online retailers that led to warning letters to businesses that sold JUUL brand products to minors. The agency also issued numerous warning letters — many in partnership with the Federal Trade Commission — to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products. These e-liquid products resemble juice boxes, candy, or cookies, and some of them included cartoon-like imagery. The agency will take additional actions under its Youth Tobacco Prevention Plan to continue to address youth use of these products.

Along with these efforts, the agency is also exploring clear and meaningful measures to make tobacco products less toxic, appealing, and addictive — with an intense focus on deterring youth use. This could include measures on flavors/designs that appeal to youth, child-resistant packaging, and product labeling to prevent accidental child exposure to liquid nicotine. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. The FDA has also expanded “The Real Cost” public education campaign with messages focused on preventing youth use of e-cigarettes and will launch a full-scale campaign this fall.