FDA Sends Warning Letter to JUUL

U.S. regulator threatens to fine vaping company and seize products.

September 10, 2019

WASHINGTON, D.C.—The Food and Drug Administration (FDA) sent a warning letter to JUUL Labs yesterday, alleging that the company is illegally advertising nicotine pods as a safer alternative to traditional cigarettes without FDA approval, CNBC reports. The agency threatens to fine or seize the vaping company’s products if it doesn’t change its marketing.

The letter came after reviewing testimony from the House Committee on Oversight and Reform’s Economic and Consumer Policy subcommittee’s investigation into JUUL. CNBC says that FDA investigators found the company broke the law “by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution.”

JUUL has 15 days to respond. Acting FDA Commissioner Ned Sharpless says companies that market tobacco products for reduced risk must show scientific evidence that their specific product does pose less risk and must receive regulatory approval before using such statements in marketing. Sharpless alleges that JUUL has ignored that law. The FDA says it is open to hearing what scientific evidence and data exists to support JUUL’s claims.

“We are reviewing the letters and will fully cooperate,” a JUUL spokesman told the Wall Street Journal.

The FDA’s move heightens scrutiny on vaping companies. North Carolina is suing eight companies, accusing them of using flavors, marketing strategies and inadequate age verification systems to sell to underage shoppers.