07.01.14
The U.S. FDA has issued a final rule setting standards for manufacturers of infant formula. The final rule contains some modifications, clarifications and technical revisions that differ from the interim final rule issued Feb. 10.
While breastfeeding is strongly recommended, most infants in the U.S. rely on infant formula for some portion of their nutrition. The final rule applies only to infant formulas intended for use by healthy infants without any unusual medical or dietary problems.
The final rule establishes current Good Manufacturing Practices (cGMPs) specifically for infant formula, which include required testing for the pathogens Salmonella and Cronobacter. The rule also establishes quality control procedures, requirements about how and when manufacturers must notify FDA about new formulas, including major changes to formulas, and requirements concerning recordkeeping.
Companies currently manufacturing infant formula for the U.S. market already voluntarily conduct many of the cGMPs and quality control procedures included in this final rule.
FDA also is publishing a final guidance document explaining how certain “eligible” infant formula manufacturers can demonstrate that their products meet the quality factor requirements of the final rule. This document applies to infant formulas that are the subject of a premarket notification submitted prior to the Sep. 8 compliance date of the final rule. The guidance document answers questions about what evidence is needed to show that these products fulfill the quality factor requirements (i.e., sufficient biological quality of protein contained in the product and normal physical growth of infants consuming the formula), related record requirements, and the process for the voluntary submission of a citizen petition to demonstrate that the eligible infant formula products meet the quality factor requirements.
FDA has also extended the comment period by 60 days to Aug. 1 for the following two proposed rules relatd to food labeling that appeared in the Federal Register of Mar. 3:
The agency action comes in response to requests for an extension to allow interested persons additional time to submit comments.
FDA is proposing to update the Nutrition Facts label for packaged foods to reflect the most recent public health and scientific information, including information about the link between diet and chronic diseases such as obesity and heart disease. The proposed label would also update out-of-date serving size requirements to better align with how much people really eat, and it features a fresh design to highlight key parts of the label such as calories and serving sizes.
While breastfeeding is strongly recommended, most infants in the U.S. rely on infant formula for some portion of their nutrition. The final rule applies only to infant formulas intended for use by healthy infants without any unusual medical or dietary problems.
The final rule establishes current Good Manufacturing Practices (cGMPs) specifically for infant formula, which include required testing for the pathogens Salmonella and Cronobacter. The rule also establishes quality control procedures, requirements about how and when manufacturers must notify FDA about new formulas, including major changes to formulas, and requirements concerning recordkeeping.
Companies currently manufacturing infant formula for the U.S. market already voluntarily conduct many of the cGMPs and quality control procedures included in this final rule.
FDA also is publishing a final guidance document explaining how certain “eligible” infant formula manufacturers can demonstrate that their products meet the quality factor requirements of the final rule. This document applies to infant formulas that are the subject of a premarket notification submitted prior to the Sep. 8 compliance date of the final rule. The guidance document answers questions about what evidence is needed to show that these products fulfill the quality factor requirements (i.e., sufficient biological quality of protein contained in the product and normal physical growth of infants consuming the formula), related record requirements, and the process for the voluntary submission of a citizen petition to demonstrate that the eligible infant formula products meet the quality factor requirements.
FDA has also extended the comment period by 60 days to Aug. 1 for the following two proposed rules relatd to food labeling that appeared in the Federal Register of Mar. 3:
- Food Labeling: Revision of the Nutrition and Supplement Facts Labels
- Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments
The agency action comes in response to requests for an extension to allow interested persons additional time to submit comments.
FDA is proposing to update the Nutrition Facts label for packaged foods to reflect the most recent public health and scientific information, including information about the link between diet and chronic diseases such as obesity and heart disease. The proposed label would also update out-of-date serving size requirements to better align with how much people really eat, and it features a fresh design to highlight key parts of the label such as calories and serving sizes.