The U.S. Food and Drug Administration (FDA) has proposed the first phase of its comprehensive review of required infant-formula nutrients since 1998, revising four standards and outlining costs manufacturers may face if the rule is finalized.
For every 100 kilocalories, the proposal would raise the minimum iodine level from 5 to 15 micrograms and lower its maximum from 75 to 50 micrograms. The minimum manganese level would fall from 5 to 1 microgram, while a maximum of 50 micrograms would be added.
The proposed vitamin A range would narrow: its minimum would decrease from 75 to 70 micrograms of retinol activity equivalents (RAE), and its maximum from 225 to 120 micrograms RAE per 100 kilocalories. Only preformed vitamin A would count toward the required levels. For vitamin D, the minimum would rise from 1 to 2 micrograms and the maximum from 2.5 to 3 micrograms per 100 kilocalories. Labels would list vitamins A and D in micrograms, with vitamin A expressed in RAE.
The FDA would retain existing requirements for chloride, potassium, selenium and sodium. It is also seeking input on whether arachidonic acid, docosahexaenoic acid and L-carnitine should be required in a future rule. This proposal would not add or remove required nutrients.
The agency said the proposed changes update its standards and are not prompted by a safety issue with formulas currently sold in the United States. Its preliminary analysis estimates annualized manufacturer costs of $8.4 million to $31.7 million, with a primary estimate of $17.6 million using a 7% discount rate. The FDA identifies reformulation, relabeling and administrative work as cost sources and says the rule may significantly affect a substantial number of small businesses.
The review is planned in three phases, with changes combined into one comprehensive final rule. The FDA has not announced dates for the next two proposed rules. Its Federal Register notice was scheduled for publication Nov. 2, and the proposed comment period runs for 120 days after publication. If finalized, the rule would take effect 60 days after Federal Register publication; manufacturers would then have three years to comply.
