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FDA Inquiring If Some e-Cigarette Makers Are Selling Devices Without Approval

Allison Inserro
The FDA said Friday it is asking 21 e-cigarette companies for more information about whether more than 40 products, including some flavored e-cigarette products, are being illegally marketed and are outside the agency’s current compliance policy. The move comes a month after the agency warned of a teen vaping epidemic and said it would be cracking down on the sale of the devices to kids.
 
The FDA said Friday it is asking 21 e-cigarette companies for more information about whether more than 40 products, including some flavored e-cigarette products, are being illegally marketed and are outside the agency’s current compliance policy. The move comes a month after the agency warned of a teen vaping epidemic and said it would be cracking down on the sale of the devices to kids.

The agency said the actions build on its Youth Tobacco Prevention Plan and FDA Commissioner Scott Gottlieb, MD, said in a statement that companies are being put on notice.

“If products are being unlawfully marketed and outside the FDA’s compliance policy, we’ll act to remove them. This includes revisiting our compliance policy that has resulted in certain e-cigarettes, including flavored e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorization,” he said. “Further, many of these products pose particular concerns given their use of flavors. We know flavors are one of the principal drivers of the youth appeal of e-cigarettes and we’re looking carefully at this.”

e-Cigarettes may help transition adult smokers off of traditional cigarettes, but the agency has said it did not foresee the extent to which the trend would be embraced by adolescents, especially the flavored varieties.

The letters are part of a new compliance policy related to the deadline for companies to submit tobacco product review applications for “deemed” tobacco products that were on the market as of August 8, 2016, the effective date of the final deeming rule that extended the FDA’s authority to additional tobacco products such as e-cigarettes. The compliance policy provided manufacturers additional time to develop more complete applications. Subsequently, the FDA received complaints that some companies may be selling new products that do not meet the premarket requirements and that were introduced or modified after the 2016 date. 

The letters sent Friday seek information about whether or not the products were on the market before or after that date, including modifications.

The most well-known of these companies, Juul Labs, didn’t receive such a letter, since the FDA recently made a surprise inspection of its offices. The Juul device is so popular with teens that they have created a verb for it—“Juuling”—because teens hide the tiny device in their palms and use it during the school day when teachers are not looking.

Last spring, the FDA issued warning letters to retailers for selling flavored e-liquids used in e-cigarettes, or vaping devices, with labeling or advertising that bears stark resemblances to kid-friendly food products, such as juice boxes, candy, or cookies. 

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