FDA Rejects PMTAs for More Than 250 E-Liquids from Mothers Milk WTA

Today, on May 19, news from foreign media reported that the U.S. Food and Drug Administration (FDA) issued a marketing denial order for over 250 flavored and tobacco-flavored e-liquids from Mothers Milk WTA on May 18.

After completing the initial acceptance review and subsequently continuing and completing a substantive scientific review of the company's premarket tobacco product applications (PMTAs), the FDA determined that these applications lacked sufficient evidence to demonstrate that the products are appropriate for the protection of public health.

For example, the applications did not provide adequate evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the potential for misuse of the new products, or that the new products could be produced consistently.

"One of our most important responsibilities is to ensure that new tobacco products undergo a scientifically rigorous premarket review," said Matthew Farrelly, director of the FDA's Center for Tobacco Products Science Office, in a statement. "We remain committed to evaluating these applications based on public health standards that consider the risks and benefits of tobacco products to the entire population."

To date, the agency has received over 26 million premarket tobacco applications for recognized products, the majority of which are e-cigarettes.

The agency stated that it has made decisions on 99% of these applications. Following Congress's clarification of the FDA's authority to regulate these products in April 2022, this includes over 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine.

Additionally, the FDA has approved 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarettes legally sold or distributed in the U.S. The FDA has also denied millions of marketing applications for products that do not meet the requirements under the law.