On May 20, the U.S. Food and Drug Administration (FDA) held a webinar to expand upon and clarify the agency’s Guidance for Industry on Infant Formula Enforcement Discretion Policy, which was announced earlier in the week. The webinar addressed who can seek enforcement discretion under the temporary guidance, what information manufacturers will need to send to FDA to qualify for enforcement discretion, and the import process for international manufacturers that are granted enforcement discretion. The webinar hosts also answered attendees’ questions.
FDA began by explaining that the temporary guidance is intended to allow for companies who do not typically sell infant formula in the U.S. to do so. The guidance also grants flexibilities that may allow for manufacturers who already produce infant formula to increase their output. FDA explained that the agency is already having discussions with established infant formula manufacturers about how they can increase production, as well as determining if reallocation of distributed products can be achieved. FDA believes that its actions, along with Abbott Nutrition resuming production in the near future, will increase the supply of infant formula in the U.S. FDA also stated that infant formula stock in retail stores is currently improving.