US FDA proposes new nutrient limits, labeling rules for infant formula
XLP•The FDA proposed changes to limits for four required infant-formula nutrients and revised labeling rules. It estimated annual costs to manufacturers of $8.4 million to $31.7 million, with a primary estimate of $17.6 million.
1. Proposed nutrient changes
The FDA proposed amending limits for iodine, vitamins A and D, and manganese, including setting a maximum level for manganese. The proposal would change how vitamins A and D are measured, allow a new source of vitamin A, and revise labeling requirements.
2. Further review planned
The agency said current required levels for chloride, selenium, potassium, and sodium were appropriate. It plans to propose rules covering the remaining nutrient specifications before issuing one final rule, and said it would conduct an external peer review of the scientific information used to develop any final rule.
3. Costs and oversight
The FDA estimated annualized costs of $8.4 million to $31.7 million for formula manufacturers, with a primary estimate of $17.6 million using a 7% discount rate. The agency has also urged the industry and supply-chain partners to oversee suppliers following product recalls and recent infant botulism cases.
