The U.S. Food and Drug Administration (FDA) on January 2, 2020, issued a policy prioritizing enforcement against flavored e-cigarette products that are manufactured and marketed in a manner that appeal to minors because the are flavored or marketed to taste or look like popular cereals, juices, or candies.
Since implementation of the FDA’s premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) on August 8, 2016, the FDA has exercised enforcement discretion as it pertains to the requirement that all e-cigarettes and ENDS products have authorization from the FDA prior to being legally marketed. As of January 2, 2020, all of these products were illegally being marketed and subject to enforcement, at the discretion of the Agency. However, the FDA’s enforcement discretion ENDS on February 2020. As stated in the FDA’s newly released policy, the FDA intends to focus on products that do not have premarket authorization, including:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
The FDA’s focus on enforcement of the products mentioned above is not the ENDS for flavored or cartridge based ENDS but an opportunity for manufacturers of these types of products to seek assistance and guidance with the submission of premarket application(s). Moreover, for all other manufacturers of ENDS products, now is also the time to submit a premarket application as the FDA intends to use its enforcement authority after May 12, 2020. The several months leading up to May 12, 2020 can allow your company and your FDA compliance attorney to gather all necessary data, to compile and prepare same, and to finally submit the premarket application. Submission of a premarket application is absolutely necessary in order to receive up to an additional year of enforcement discretion from the FDA.
Our firm can assist and provide legal guidance to any manufacturer who intends to continue manufacturing ENDS products. If you need assistance, please contact Mr. Rafael (Ralph) Gaitan, Esq., who is experienced in these matters. Mr. Gaitan can be reached at (786) 440-8115 or via email at [email protected].