FDA Rejects Over 889,000 Tobacco Applications for Noncompliance

Oct.17.2022

FDA rejects 889,000 tobacco product applications while accepting over 1,600, mostly for e-cigarettes and e-liquids. Warning letters sent to manufacturers and retailers.

The US Food and Drug Administration (FDA) has announced that it has issued more than 889,000 Refuse to Accept (RTA) letters as of October 7, to pre-market tobacco product applications (PMTAs) that do not meet acceptance criteria.

The organization also announced that the FDA has received over 1,600 applications, the majority of which are for electronic cigarettes or e-liquid products.

Although the review process is ongoing, the FDA remains vigilant in regulating the market and will continue to use our compliance and enforcement resources to curb the illegal marketing of non-tobacco nicotine products. To date, the FDA has issued more than 60 warning letters to manufacturers, including popular brands among young people such as Puff Bar," stated the FDA in a press release. "The warning letters include products that have submitted applications but have received negative actions from the agency.

The FDA has sent over 300 warning letters to retailers demanding that they cease selling synthetic nicotine e-cigarette products to minors, and has imposed civil fines on two retailers for selling e-cigarette products to minors.

So far, the FDA has not authorized any synthetic nicotine e-cigarette products. Therefore, all synthetic nicotine e-cigarette products on the market are being sold illegally and are at risk of FDA enforcement action," said the FDA. "Retailers or distributors selling or distributing unauthorized e-cigarettes are breaking the law and those engaging in such behavior will face FDA enforcement risks, such as seizures, injunctions, or civil fines.

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