Today, FDA issued marketing denial orders to the firm Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids. After completing initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health. For example, among other things, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” says Matthew Farrelly, Ph.D., Director of the Office of Science within FDA’s Center for Tobacco Products. “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.”
There are several phases in the PMTA review process. If an application does not meet the necessary requirements for a given phase, FDA may issue a refuse to accept letter or refuse to file letter and not move the application forward in the process. During the final substantive review phase, FDA evaluates the scientific information and data in applications to determine if marketing of the new products meet the requirements of the appropriate for the protection of public health standard set forth by Congress for new tobacco products in the 2009 Family Smoking Prevention and Tobacco Control Act.
Following FDA’s rigorous scientific review, tobacco products that receive a marketing denial order may not be offered for sale, distributed, or marketed in the U.S. 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.
Today’s action is further evidence of FDA’s progress toward making sure that all new tobacco products have undergone science-based review and received marketing authorization by FDA before they can be legally marketed.
“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, Ph.D., M.P.H., Director of FDA’s Center for Tobacco Products. “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 FDA’s authority to regulate these products in April 2022. Further, 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 U.S. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.
Find more information about FDA’s tobacco product authorizations and marketing denial orders on FDA’s website.