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April 2013

FDA Proposes Adding Selenium to Infant Formula Nutrient Requirements

The U.S. Food and Drug Administration (FDA) is proposing to update current regulations on infant formula with the addition of selenium to the list of required nutrients.

Selenium is an essential trace mineral found in soil, water and some foods. Selenium is required for functioning of the body's antioxidant enzymes and for cell growth and survival.

According to the Federal Food, Drug, and Cosmetic Act (FFDCA), infant formula is defined as food that serves a special dietary purpose as a complete or partial substitute of human breast milk. The FDA requires infant formula to have minimum amounts of 29 nutrients and also maximum amounts of nine of these nutrients. In addition, there are many components that are also added to enhance the beneficial effects of infant formula, such as emulsifiers and stabilizers, docosahexaenoic acid (DHA), arachidonic acid (ARA), probiotics, prebiotics, taurine, L-carnitine, choline, inositol and biotin (vitamin B7).

In the recently proposed rule, the FDA states that at the time nutrient regulations for infant formula were initially established, selenium was not recognized as an essential nutrient. Currently, selenium is known to be a nutritional trace mineral that plays an important role in detoxification and antioxidant defense in the body. While selenium is not currently a required nutrient in infant formula, all formals that are manufactured in the United States do include the mineral. Additionally, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance (RDA) for selenium for infants in 1989.

After reviewing the available evidence on selenium intake in infants, the FDA proposes that a minimum of 2 micrograms selenium be required per 100 kilocalories of infant formula, with a maximum of 7 micrograms per 100 kilocalories of formula. This proposal would also add selenium to the list of nutrients that must be included on nutrition labels of infant formula.

By updating the regulations, the FDA hopes to maintain safe nutrient levels for both formula products made in the United States and international products that aim to enter the US market.

To read the full proposal, please visit

For more information about selenium, please visit Natural Standard's Foods, Herbs & Supplements Database.


  1. Natural Standard: The Authority on Integrative Medicine.
  2. The Office of the Federal Register (OFR).
  3. US Food and Drug Administration.

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