FDA Issues Warning Letters For Unauthorized Sales Of Synthetic Nicotine

The federal Consolidated Appropriations Act that went into effect on April 14 clarified the FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine.

Recently, FDA issued its first two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization.

Collectively, these two companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA.

Neither company submitted a premarket application for its non-tobacco nicotine products by the May 14, 2022, deadline as required by the new law.

In addition, FDA issued 107 warning letters to retailers for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.

The law makes it clear that tobacco products, including non-tobacco derived nicotine products, cannot be sold legally to customers under age 21 following passage of the new law.

Any new non-tobacco nicotine product that has not received premarket authorization from FDA cannot be legally marketed.

FDA is processing applications for one million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline.

FDA is preparing to issue refuse-to-accept (RTA) letters soon for those applications that do not meet the criteria for acceptance.

When companies are found to be illegally marketing non-tobacco nicotine products, the agency will typically first issue warning letters to achieve voluntary compliance and will pursue enforcement actions, as needed, including civil money penalties, no-tobacco sale orders, seizure, or injunction.

In addition, any unauthorized non-tobacco nicotine products detected for import into the United States can be detained or refused admission.

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