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Infant Formula "With Iron" Statement Is Misleading - Mead Johnson

This article was originally published in The Tan Sheet

Executive Summary

Current regulations that require labeling of infant formulas containing at least 1 mg of iron per 100 calories to state "with iron" or "iron fortified" should be revised, Mead Johnson maintains in a citizen petition filed with FDA Jan. 24.

Current regulations that require labeling of infant formulas containing at least 1 mg of iron per 100 calories to state "with iron" or "iron fortified" should be revised, Mead Johnson maintains in a citizen petition filed with FDA Jan. 24.

Instead, labeling for formulas that contain less than 1 mg of iron per 100 calories should be required to carry a statement such as "Low Iron" on the principal display panel and read "Additional Iron May Be Necessary" on the information panel, the Bristol-Myers Squibb subsidiary states.

Meanwhile, "iron-fortified formulas should have the term 'with iron' removed from the front label," Mead Johnson argues; the firm markets the Enfamil infant formula brand.

While there is no clinical proof that iron leads to gastrointestinal discomfort in infants, many people believe it does, Mead Johnson states. "Highlighting the iron content of infant formula unnecessarily draws attention to this ingredient and may tend to aggravate these complaints because of this widely held misconception," the firm asserts.

The company refers to a recommendation from the American Academy of Pediatrics Committee on Nutrition. In the July issue of Pediatrics, the committee suggested removing the statement "with iron" from iron-fortified formulas might increase consumers' use of the products, which are preferable to the low-iron varieties (1 (Also see "Infant Formula Iron Content Labeling Elimination Suggested By Pediatricians" - Pink Sheet, 19 Jul, 1999.)).

At a 1996 public meeting, the Infant Formula Council said there was no medical or nutritional need for low-iron infant formulas. Publication of a final rule on infant formula quality factors is one of the Center for Food Safety & Applied Nutrition's "A-List" priorities for 2000 (2 (Also see "Dietary Supplement Enforcement Procedure Streamlining Planned By CFSAN" - Pink Sheet, 14 Feb, 2000.)).

Mead Johnson also notes the current requirement "may be false or misleading because it suggests that each formula is also available in a 'low iron' form. With a few exceptions, this is not the case."

Worldwide sales of Enfamil were up 13% to $621 mil. in 1999 and rose 10% to $560 mil. in the U.S. Fourth quarter worldwide sales reached $175 mil., up 24%. The jump was due, in part, to a slightly higher birth rate and Y2K stockpiling, Bristol-Myers said.

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