Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

May 19, 2022By Ricardo Carvajal

As one of several means to alleviate the ongoing shortage of infant formula in the U.S., earlier this week FDA issued a guidance document that outlines the factors FDA will consider in deciding whether to allow the distribution of an infant formula that does not meet all applicable statutory and regulatory requirements. Those requirements are extensive, as infant formula is the most tightly regulated of all human food products. In addition to having to meet the requirements that are generally applicable to all foods, an infant formula must also meet specific requirements with respect to its formulation, manufacture, and what are referred to as “quality factors” – namely a demonstration of sufficient biological quality of the protein in the formula, and the ability of the formula to support normal physical growth. Meeting these quality factors can require specific animal and human studies, such that bringing a formula to market can be an expensive endeavor with a long lead time.

Ordinarily, a “new” infant formula cannot be marketed without prior notification to FDA. (In this context, “new” is a term of art that encompasses previously marketed infant formulas in which there is a “major change,” as well as infant formulas that have not previously been notified to FDA. In turn, the definition of “major change” encompasses a variety of scenarios – including first entry to the U.S. market.) The premarket notification submitted to FDA must demonstrate that the formula meets applicable requirements. If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. Over the years, this notification requirement has served as an effective gatekeeper, notwithstanding the fact that it does not strictly constitute  premarket approval.

FDA’s new guidance invites any manufacturer of an infant formula “that is safe and nutritionally adequate but may not comply with all FDA statutory and regulatory requirements” to submit information in support of a request for enforcement discretion. The guidance lists the information elements that should be included in the request – essentially a compendium of information that will enable FDA to assess whether the formula is indeed safe and nutritionally adequate. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S. market. However, by its terms, the guidance will remain in effect only until November 14, 2022, at which time FDA will decide whether to extend it. It remains to be seen whether the uncertainty associated with that potentially limited window of opportunity dampens foreign manufacturers’ interest. FDA announced a webinar to be held on May 20th that will provide an overview of the guidance and give manufacturers an opportunity to ask questions.

In late-breaking news, President Biden invoked the Defense Production Act to help bolster production of infant formula. The President delegated authority to the Secretary of Health and Human Services to determine “the proper nationwide priorities and allocation of all ingredients necessary to manufacture infant formula, including controlling the distribution of such materials (including applicable services) in the civilian market, for responding to the shortage of infant formula within the United States.” We will be tracking implementation of that authority.