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Final Rule Requiring Selenium in Infant Formula Effective June 2016

Monday, October 12, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has confirmed June 22, 2016, as the effective date of a June 2015 final rule amending the regulations on nutrient specifications and labelling for infant formula to add the mineral selenium to the list of required nutrients and establish minimum and maximum levels of selenium in infant formula.

Section 412(i) of the Federal Food, Drug, and Cosmetic Act requires infant formulas to contain 29 specific nutrients and also sets minimum levels for each of these nutrients as well as maximum levels of nine nutrients. The FDA is authorized under the law to revise the list of required nutrients and the required level for any required nutrient.

At the time the FDA established nutrient specifications for infant formula, selenium was not recognized as an essential nutrient and was therefore not included in the statute. However, selenium has subsequently been recognized as an essential nutrient and the FDA decided last June to add that mineral to the list of nutrients along with the requirement to list the amount of selenium per 100 kilocalories in the formula. The FDA has set 2.0 mg selenium/100 kcal as the minimum level and 7.0 mg/100 kcal as the maximum level of selenium in infant formulas. 

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