The US Food and Drug Administration (FDA) issued marketing denial orders to the firm Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.
After completing an initial acceptance review and subsequently completing a scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.
For example, among other aspects, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the US market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently, according to a release from the FDA.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” says Matthew Farrelly, PhD, director of the office of science within the FDA’s Center for Tobacco Products, in a release. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Tobacco products that receive a marketing denial order may not be offered for sale, distributed, or marketed in the US. Additionally, such products may not be introduced or delivered for introduction into interstate commerce, and if the product is already on the market, the product must be removed from the market. Manufacturers, distributors, and retailers who do sell, distribute, or market these products are violating the law and are at risk of enforcement action.
“We’ve made considerable progress in reviewing the unprecedented volume of applications that have been submitted—completing review of 99% of submissions to date,” says Brian King, PhD, MPH, director of FDA’s Center for Tobacco Products, in a release. “The remaining reviews are going to be completed, but it’s critical that we take the appropriate time needed by the multidisciplinary teams involved to ensure that the reviews are both scientifically and legally defensible.”
To date, the agency has received premarket tobacco applications for more than 26 million deemed products, the majority of which are e-cigarettes. The agency has made determinations on 99% of these 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.
Further, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the US. The FDA has also denied marketing applications for millions of products that did not meet requirements.