FDA News

In 'undercover blitz,' FDA cracks down on e-cigarette retailers, manufacturers

Scott Gottlieb, MD
Scott Gottlieb

The FDA announced today that it has taken enforcement actions in the sale and marketing of e-cigarettes to youth.

In a press release, the agency called the “nationwide, undercover blitz of brick-and-mortar and online stores” the largest coordinated enforcement effort in its history, with the FDA issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors.

“We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year,” FDA Commissioner Scott Gottlieb, MD, said in the release. “But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger. This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors.”

The FDA has given five e-cigarette companies 60 days to describe how they will address widespread use of their products among youth. If the companies fail to do so, or if they do not appropriately address the issue, the FDA said it will consider revisiting “the current policy that results in these products remaining on the market without a marketing order from the agency.” This could require that the companies remove some or all of their flavored products that appeal to youth until they receive premarket authorization.

In April, Gottlieb revealed the agency’s plan to curb use of electronic nicotine delivery systems among youth, including a large-scale undercover crackdown on the sale of the products in stores and online and requesting documents on marketing and research conducted by manufacturers.

The FDA announced today that it had issued more than 60 warning letters and fines to businesses that sold JUUL brand products to minors this spring.

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” Gottlieb said in the release. “We cannot allow a whole new generation to become addicted to nicotine. In the coming weeks, we’ll take additional action ... to immediately address the youth access to, and the appeal of, these products.”

The FDA threatened to extend “compliance dates for submission of premarket applications” if manufacturers did not reverse the current trends in youth e-cigarette use.

Most violations the FDA cited were for the illegal sale of five e-cigarette products, including Vuse, Blu, JUUL, MarkTen XL and Logic, which comprise more than 97% of the U.S. markets for e-cigarettes, according to the release.

The FDA added that 12 warning letters have been sent to other online retailers that sold misleadingly labeled or advertised e-liquids that resembled kid-friendly food products like candy or cookies. The FDA sent warning letters in May to manufacturers of the products, which are subsequently not being sold with the labeling and advertising. However, the retailers that are receiving the letters are still advertising and selling the products, according to the release.

“The agency will continue to monitor and take action against companies that sell tobacco products that might mislead a young child into thinking the product is appropriate for them to consume as food,” the FDA said.

Disclosure: Gottlieb reports no relevant financial disclosures.

Scott Gottlieb, MD
Scott Gottlieb

The FDA announced today that it has taken enforcement actions in the sale and marketing of e-cigarettes to youth.

In a press release, the agency called the “nationwide, undercover blitz of brick-and-mortar and online stores” the largest coordinated enforcement effort in its history, with the FDA issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors.

“We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year,” FDA Commissioner Scott Gottlieb, MD, said in the release. “But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger. This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors.”

The FDA has given five e-cigarette companies 60 days to describe how they will address widespread use of their products among youth. If the companies fail to do so, or if they do not appropriately address the issue, the FDA said it will consider revisiting “the current policy that results in these products remaining on the market without a marketing order from the agency.” This could require that the companies remove some or all of their flavored products that appeal to youth until they receive premarket authorization.

In April, Gottlieb revealed the agency’s plan to curb use of electronic nicotine delivery systems among youth, including a large-scale undercover crackdown on the sale of the products in stores and online and requesting documents on marketing and research conducted by manufacturers.

The FDA announced today that it had issued more than 60 warning letters and fines to businesses that sold JUUL brand products to minors this spring.

“While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids,” Gottlieb said in the release. “We cannot allow a whole new generation to become addicted to nicotine. In the coming weeks, we’ll take additional action ... to immediately address the youth access to, and the appeal of, these products.”

The FDA threatened to extend “compliance dates for submission of premarket applications” if manufacturers did not reverse the current trends in youth e-cigarette use.

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Most violations the FDA cited were for the illegal sale of five e-cigarette products, including Vuse, Blu, JUUL, MarkTen XL and Logic, which comprise more than 97% of the U.S. markets for e-cigarettes, according to the release.

The FDA added that 12 warning letters have been sent to other online retailers that sold misleadingly labeled or advertised e-liquids that resembled kid-friendly food products like candy or cookies. The FDA sent warning letters in May to manufacturers of the products, which are subsequently not being sold with the labeling and advertising. However, the retailers that are receiving the letters are still advertising and selling the products, according to the release.

“The agency will continue to monitor and take action against companies that sell tobacco products that might mislead a young child into thinking the product is appropriate for them to consume as food,” the FDA said.

Disclosure: Gottlieb reports no relevant financial disclosures.