The guidance – which is currently in draft form and interested parties can comment on its contents online – covers all infant formulas, including those that are considered medical foods.
It follows earlier legislation reforms that introduced requirements related to manufacturers notifying the FDA about interruptions in critical food manufacturing. Essentially, the guidance is designed to better explain the scope of the legal requirements laid out in Section 424 of the FD&C Act.
“While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications from manufacturers to FDA can play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages,” the regulator explains in the draft guidance.
“Timely notifications that include specific information about the situation allow FDA to evaluate the situation and determine an appropriate course of action. When FDA does not receive timely, informative notifications, FDA’s ability to respond appropriately is limited.”
When should a manufacturer notify FDA?
By law, that needs to happen ‘as soon as practicable but not later than 5 business days’ after a manufacturer discontinues a product or experiences interruptions likely to lead to ‘meaningful’ supply disruption.
However, the guidance suggests that infant formula manufacturers should voluntarily notify the regulator ‘at least 6 months before permanently discontinuing manufacturing an infant formula product’.
The document also clarifies that ‘meaningful disruption’ does not refer to pauses in manufacture due to routine maintenances, changes or discontinuance of flavors and colors – but if companies are unsure whether their particular case requires a notification, they should lodge one anyway.
What should the notification include?
According to legislation, the notification must state: the manufacturer’s name; the name of the impacted formula products; the nature of the issue, e.g. discontinuation or interruption; and the reason for this.
But through the guidance, the FDA has included a list of voluntary details that could help the regulator to ‘appropriately identify the affected products, determine the potential for and the criticality of a supply chain disruption, and better assess the overall state of the market’.
Some of these details – which can be read in full in the draft linked below – include UPC codes, what alternative products are available from the same company; the shelf life and product volume of the impacted product; what markets are impacted (geographical distribution), and so on.
How should a notification be submitted?
By email, with a subject line ‘Infant Formula – Permanent Discontinuance’ or ‘Infant Formula – Interruption in Manufacturing’ as relevant.
“Manufacturers should submit separate notifications for permanent discontinuances and interruptions in manufacturing,” the guidance reads.
“A single notification (i.e., a notification for permanent discontinuance(s) or a notification for interruption(s) in manufacturing), however, can include more than one affected infant formula product.
“If a manufacturer markets two different infant formula products and intends to permanently discontinue one product and temporarily stop manufacturing another, we ask that the manufacturer submit one notification for the permanent discontinuance and another notification for the interruption.
Manufacturers that fail to notify the regulator will be issued with a noncompliance letter, which will be published online within 45 days of sending along with any response from the manufacturer.
Interested parties can comment on the draft guidance until February 3, 2025.
Visit fda.gov for more information and to access the document in full.