FDA Denies Marketing of 250+ Flavored and Tobacco-Flavored E-Liquids

On May 18, The U.S. 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 initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the 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. Read more here.