FDA Sends 69 PMTA Warning Letters to E-Cigarette Companies

On March 19, the U.S. Food and Drug Administration (FDA) sent out three warning letters to vapor companies. According to the latest announcement, this year, the total number of companies selling vapor products without obtaining regulatory approval through the agency's premarket tobacco product application (PMTA) process has reached 69.Warning Letters.

The latest letters were sent to Vapor Outlet in Arizona, Vapor Tech Hawaii, and Vaporium in Illinois. The FDA noted in its letter to Vaporium that the company continues to "manufacture, sell, and/or distribute to customers in the U.S. its Vaporium 6 mg red and white and blue 70/30 30 ML e-liquid products" without any marketing authorization.

"Your company is a registered manufacturer with 19,860 products listed by the FDA. It is your responsibility to ensure that your tobacco products comply with every applicable provision of the FD&C Act and FDA implementing regulations." "Failure to adequately address this issue may result in regulatory action, including but not limited to civil monetary penalties, seizure, and/or injunctions."

Companies receiving FDA warning letters must submit a written response within 15 business days of receiving the letter, detailing the company's corrective actions, including the date of cessation of the unlawful sale and/or distribution of products. They are also required to develop a plan to maintain compliance with the FD&C Act in the future.

So far, many of the FDA's letters have been sent to local vape shops that produce their own e-liquids in-store. For example, the letter to Vapor Tech Hawaii noted that the FDA had determined that it was "manufacturing, selling, and/or distributing to customers its Vapor Tech Hawaii Waikikiwi 100 ML 3mg e-liquid products without sales authorization."

On March 12, the FDAissued warnings to 13 companies producing and selling unauthorized e-liquids.Warning Letters.