Mothers Milk WTA received a marketing denial order from the Food and Drug Administration on May 18 for more than 250 flavored and tobacco-flavored e-liquids.
After completing an initial acceptance review and subsequently continuing and completing a substantive scientific review of the company’s Premarket Tobacco product Application (PMTA), FDA determined that these applications lacked sufficient evidence that the product was suitable to protect public health.
For example, the application did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the United States market, information to assess the potential for abuse of the new product, or that the new product could be produced consistently.
“One of our most important responsibilities is to ensure that new tobacco products undergo scientifically rigorous premarket review.” Matthew Farrelly, director of the Office of Science at the FDA’s Center for Tobacco Products, said in a statement. “We remain committed to evaluating these applications against public health standards that take into account the risks and benefits of tobacco products for the entire population.”
To date, the agency has received premarket tobacco applications for more than 26 million certified products, mostly e-cigarettes.
The agency says it has made decisions on 99 percent of those applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified the FDA’s authority to regulate these products in April 2022.
In addition, the FDA has approved 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarettes that can be legally sold or distributed in the U.S. The FDA has also rejected marketing applications for millions of products that do not meet the requirements in the law.