Marci Ardinger is the Associate Director of Project Management at Clinipace Worldwide.
Infant formulas play an important role in the overall health of infants that consume them, and the FDA has recognized that infant formulas for specific uses (i.e., infants with inborn errors of metabolism, low birth weight and other medical or dietary issues) might need to differ in their nutrient content from the formulas manufactured and marketed for healthy, term infants. These “exempt infant formulas” are therefore considered exempt from the specific subsections that provided guidance regarding the nutrient content and reporting of the nutrient content of infant formulas in the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 412, which was written specifically to “ensure the safety and nutrition of infant formulas.” Instead, the terms and conditions for exempt infant formulas were provided in the guidance 21 CFR 107.50, “Exempt Infant Formulas.”
Last week (April 14, 2016), the FDA issued final guidance for industry on exempt infant formula production. This guidance aims to provide an understanding of the recommended manufacturing standards for exempt infant formulas as they relate to those for non-exempt infant formulas. The manufacturing of these non-exempt infant formulas is guided by 21 CFR 106, which was last amended on June 10, 2014.
The FDA recommends that future manufacturing of exempt formulas follow subparts A (general provisions), B (current good manufacturing process), C (quality control procedures), D (conduct of audits) and F (records and reports) of 21 CFR 106, rather than 21 CFR 107.50. Doing so ensures the exempt formulas adhere to sound public health policy that these products should be manufactured using protocols and procedures that are at least equivalent to those for products consumed by healthy, term infants.
The FDA will be issuing new terms and conditions for exempt formulas in a new rule in the future. In the meantime, manufacturers should use the 21 CFR 106 subparts recommended by the FDA to guide the production of these formulas.
Clinipace has extensive experience managing global nutrition-related studies, including expertise with infant formulas, total parenteral nutrition (TPN), functional foods, food hypersensitivity studies and food for special purposes (FSMP). Our team has managed over 170 sites worldwide with over 5,000 subjects enrolled in nutrition-related multi-phase studies, regulatory submissions and registries.
We’re happy to answer any questions you may have about the FDA’s final guidance on exempt infant formula and how it might effect your clinical trial, or any other nutrition-related study questions you may have. Contact us and a member of our team will get back to you shortly. We look forward to hearing from you!
- Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports
- Federal Register Notice – Final Rule – Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
- Note: Corrections to the final rule were made July 2014. See Federal Register Notice – Final Rule Corrections – Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula.
- Consumer Update: FDA 101 – Infant Formula
- Constituent Update: FDA Sets Standards for Infant Formula