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Jump to Key Points Oct 29 (Reuters) - The US Food and Drug Administration proposed new nutrient limits and labeling rules for infant formula on Thursday, as part of its ongoing review of baby formula nutrients.
The FDA launched "Operation Stork Speed" last year, which began a nutrient review process and increased testing for heavy metals and other contaminants in infant formula, while also urging companies to develop new products.
Here are more details:
• The rule, if finalized, will amend limits for four required nutrients — iodine, vitamin A, vitamin D, and manganese — and establish a maximum level for manganese
- FDA proposes revised infant formula nutrient limits for iodine, vitamin A, vitamin D, manganese.
- Manganese: new maximum level proposed; vitamin A/D measurement methods would change.
- New vitamin A source + updated labeling requirements included.
- Chloride, selenium, potassium, sodium deemed appropriate at current required levels.
- FDA cites recalls, infant botulism; final rule to follow remaining nutrient specs review.
• It would also change how vitamins A and D are measured, allow a new source of vitamin A and revise labeling requirements
• The agency assessed four additional nutrients — chloride, selenium, potassium, and sodium — and concluded that current required levels were appropriate
• FDA has urged the infant-formula industry and supply-chain partners to exercise substantive oversight of their suppliers following several product recalls and recent infant botulism cases
• The agency plans to propose more rules covering the remaining nutrient specifications, and then issue one final rule covering all the changes
• The FDA said it would conduct an external peer review on all scientific information used to develop any final rule
• The agency estimated the changes would lead to annualized costs of $8.4 million to $31.7 million a year for formula manufacturers, with a primary estimate of $17.6 million at a 7% discount rate
(Reporting by Sneha S K in Bengaluru; Editing by Jonathan Ananda)
