Overview
- The FDA formally proposed the first phase of a multi-step review on Oct. 29 that would change numeric requirements and measurement units for four nutrients: iodine, manganese, vitamin A and vitamin D.
- Key numeric changes include raising iodine’s minimum from 5 to 15 micrograms with a 50 mcg cap, lowering manganese’s minimum from 5 to 1 mcg per 100 kcal and adding a 50 mcg cap, cutting vitamin A slightly and switching its units to retinol activity equivalents, and doubling vitamin D’s minimum to 2 micrograms while raising its maximum to 3 micrograms.
- The rule comes with new contaminant-testing results the FDA called largely reassuring, a public dashboard for test data, and a request for input on commonly added but not required ingredients such as DHA, ARA and L-carnitine.
- The agency will open a public-comment period and conduct external scientific peer review before proposing further nutrient changes and issuing a single consolidated final rule.
- The FDA estimated annualized compliance costs to manufacturers between $8.4 million and $31.7 million with a central estimate of $17.6 million, a change that could affect product formulation, labeling and supply-chain oversight for parents and clinicians.