On December 2, 2024, the Food and Drug Administration (FDA) published Draft Guidance implementing the statutory requirement that infant formula manufacturers notify FDA of a permanent discontinuance or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States. The Draft Guidance sets forth FDA’s interpretation of key terms in the statutory requirement, as well as the procedures for submitting a required notification.
Background
The Food and Drug Omnibus Reform Act of 2022 (FDORA) added section 424 to the Federal Food, Drug, and Cosmetic Act (FDCA), which requires that manufacturers of “critical food” notify FDA of a permanent discontinuance or interruption in the manufacture of the critical food that is likely to lead to a meaningful disruption of the U.S. supply of such product. The FDCA defines “critical food” to include both infant formula and medical food products, although the Draft Guidance covers only infant formula. The agency’s approach in the Draft Guidance may, however, be indicative of FDA’s expectations with respect to notifications regarding a discontinuance or interruption in the manufacture of medical foods as well.
Key Elements of the Draft Guidance
The following are key elements of the Draft Guidance:
- Timing. Infant formula manufacturers must make a notification, when required, “as soon as practicable, but not later than 5 business days” after the triggering event. FDA states in the Draft Guidance that, in the agency’s experience, “it generally should be possible for the manufacturer to provide notice within one or two calendar days of the decision to discontinue or the interruption.” Additionally, FDA recommends that manufacturers should not wait for complete information to notify the agency, and should make an initial notification and provide updates as further details emerge.
- When to notify. FDA clarifies in the Draft Guidance that a permanent discontinuance is “a decision by an infant formula manufacturer to cease manufacturing and distributing its product indefinitely, for any reason,” while a “meaningful disruption” in supply is a change that is “reasonably likely to lead to a significant reduction in the supply” of infant formula (i.e., a reduction that is “more than negligible”) “that affects the ability of the manufacturer to meet expected demand for its product.” The latter category does not include interruptions due to routine maintenance or insignificant formulation or manufacturing changes, as long as operations are expected to restart shortly. FDA also clarifies that the determination of whether an interruption is likely to lead to a “meaningful disruption” in supply should be considered from the perspective of the particular manufacturer’s capacity and supply.
- Content. The Draft Guidance specifies information that must be included in a notification to FDA, as well as a longer list of information that the agency recommends manufacturers include voluntarily. The required elements of a notification are:
- The manufacturer’s name;
- The name of each infant formula product impacted;
- Whether the notification relates to a permanent discontinuance in manufacturing one or more infant formula product(s) or an interruption in the manufacture of one or more infant formula product(s); and
- The reason(s) for the permanent discontinuance or interruption in manufacturing.
- Method. Under the Draft Guidance, manufacturers should submit notifications to CriticalFoodShortage@fda.hhs.gov. FDA asks that separate notifications be submitted for permanent discontinuances and interruptions, but that a single notification can cover multiple products.
- Failure to Notify. If an infant formula manufacturer fails to notify the agency, FDA will issue a “noncompliance letter,” which it will post on its website within 45 days of issue. The agency will post the manufacturer’s response upon request. If the agency determines that its letter was an error or that the manufacturer had a reasonable basis for failing to notify, FDA will not post the letter and response online.
Comment Period
Interested parties should submit comments on the Draft Guidance by February 3, 2025.
If you have any questions concerning the material discussed in this client alert, please contact members of our Food, Beverage, and Dietary Supplements practice.
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