The Food and Drug Administration is urging the company behind Juul's leading e-cigarette brand to gather information on how its products appeal to children and adolescents, opening the door to possible enforcement measures.
In a rare step, the FDA issues a 904 (b) letter referring to the section of the Family Smoke Prevention and Tobacco Control Act. It's been three years since the FDA sent this type of letter for the last time.
In this case, the Juul agency asks for a range of materials from the company, including marketing materials, research on whether certain product design features, ingredients or specifications are suitable for different age groups.
The FDA will review the information, and if there is cause for concern, it could take enforcement action. It is planned to send more letters to other manufacturers. Failure to comply with the requirements will violate the law and be enforceable.
"We still do not fully understand why these products are so popular with adolescents," said FDA Commissioner Scott Gottlieb in a statement. "But it's imperative that we find out, and quickly, that these documents can help us."
A Juul spokeswoman did not immediately respond to CNBC's request for comment. The company said its products are intended for adult smokers who want to switch from conventional products.
Gottlieb also said Tuesday that he has issued 40 warning letters to traders who have illegally sold Juul products to minors since the beginning of March. The agency began an undercover campaign nationwide on April 6 to tackle underage sales both in stores and online. It will continue until the end of the month.
eBay has removed several entries for Juul products and has voluntarily introduced new measures to prevent others like them from appearing on the site after the FDA has contacted the company, Gottlieb said.
"Let me be clear to retailers, and this lightning and the resulting actions should serve as an indication that we will not tolerate the sale of tobacco products to young people," said Gottlieb in a statement.
In response to reports from adolescents using their products, Juul has invested in education and prevention measures such as "secret buyers" to ensure that retailers do not sell to minors, said Juul Labs's Chief Administration Officer, Ashul Gould, to CNBC December.
The FDA plans to announce further enforcement actions focused on companies that the agency believes are misleading products for children, Gottlieb said.
"America's youth should not use tobacco products," Health and Human Services Secretary Alex Azar said in a statement. "We at HHS are proud of the work that Commissioner Gottlieb and the FDA are doing to crack sales and commercialization of e-cigarettes to minors."