On June 9, 2014 the U.S. Food and Drug Administration released a final rule regarding the manufacturing standards of infant formula. The final rule—which amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufactures of infant formulas—is meant to ensure that formulas for infants without unusual medical or dietary problems are safe and support healthy growth. The rule also establishes current good manufacturing practices (CGMPs), and sets a date of September 8, 2014 for manufacturer compliance.
According to the FDA, many companies currently manufacturing infant formula for the U.S. market already produce safe products and voluntarily apply many of the CGMPs and quality control procedures included in the final rule. In fact, FDA drafts of this rule have existed since 1986. However, this final rule will set in place federally enforceable requirements for the safety and quality of infant formula, which most infants in the U.S. rely on for some portion of their nutrition.
The agency will be accepting comments from the public on issues or information not previously considered in the interim final rule that was set in February 2014. Below is a summary of some important items in the final rule that will affect Covance and our infant formula clients:
Laboratories will be required to use fully validated methods (like AOAC), or scientifically valid methods, which would need to be documented.
- Stability testing is required at four-month intervals for new products/formulations and end of shelf-life testing for all existing products. This could, at minimum, double the rate of stability testing for many companies.
- Strict testing for Salmonella and Chronobacter, which will require a significant increase in laboratory testing.
- Testing must be performed of every nutrient, in every lot, of finished infant formula product, eliminating the testing of “marker” units.
- Stability testing must be performed on every type of formula that a company manufacturers, compared to “representative” products. A comprehensive study is required on any new formula and a routine stability program is required for all subsequent batches.
- Manufacturers can request an exemption from testing every formula for a Protein Efficiency Ration (PER) if they have a validated alternative based on sound scientific principles. The official method referenced by FDA is the Covance method.
Covance has more than 40 years of experience with the analysis of infant formula, including developing many of the official test methods. Covance scientists were members of the original Association of Analytical Communities (AOAC) Task Force–which was requested by the FDA and organized and led by FDA and industry scientists–for the development of infant formula methods. A Covance scientist also chairs the new AOAC Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) methods, which other Covance scientists are also involved.
For more information on these infant formula regulations, visit the U.S. Food and Drug Administration’s website.
Visit us at http://nutri.covance.com to learn more.