FDA rejects over 250 e-liquid PMTAs

Time： 2023-05-22

The FDA issued a marketing refusal order to Mothers Milk WTA on May 18 for more than 250 flavored and tobacco-flavored e-liquids. After completing the initial ...

The FDA issued a marketing refusal order to Mothers Milk WTA on May 18 for more than 250 flavored and tobacco-flavored e-liquids.

After completing the initial acceptance review and subsequently continuing and completing a substantive scientific review of the company's premarket tobacco product application (PMTA), FDA determined that the 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 U.S. market, information to assess the potential for abuse of the new product, or that the new product could be manufactured 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 in the FDA's Center for Tobacco Products, said in a statement. "We remain committed to evaluating these applications against public health criteria that consider the risks and benefits of tobacco products to the population as a whole."

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

The agency said it had 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 clarifies FDA’s authority to regulate these products in April 2022.

Additionally, the FDA has approved 23 tobacco-flavored e-cigarette products and devices, the only ones that can currently be legally sold or distributed in the U.S. The FDA has also denied marketing applications for millions of products that do not comply with the law.

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