FDA Issues Draft Guidance Concerning the Type and Quality of Scientific Evidence Underlying Structure/Function Claims Made in Infant Formula Labels and Labeling
November 18, 2016
The FDA is reopening the comment period on the draft guidance for industry about the type and quality of scientific evidence substantiating structure/function claims made in infant formula labels and labeling.
The FDA is taking this action in response to requests for additional time to submit comments. The comment period will reopen on November 21, 2016 and close on February 21, 2017.
For additional information, see the Federal Register Notice for the reopening of the comment period.
Original Constituent Update
September 9, 2016
The U.S. Food and Drug Administration has issued draft guidance for industry to help infant formula manufacturers making structure/function claims comply with the requirement that all claims in infant formula labels and labeling be truthful and not misleading.
“Structure/function” claims are statements made about the effects of a product or its constituent on the normal structure or function of the body. An example of a structure/function claim in infant formula labeling is a statement that the formula “supports digestion.”
In the draft guidance, “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling,” the FDA describes its recommendations for the type and quality of scientific evidence that is appropriate to substantiate (i.e., support) structure/function claims made about an infant formula by the product’s manufacturers or distributors. The draft guidance provides recommendations with respect to all infant formulas, including formulas marketed for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.
The FDA does not preapprove structure/function claims in the labeling of foods (including infant formula).This draft guidance specifically focuses on infant formula, which provides the sole or a primary source of nutrition for many infants during a critical period of growth and development. This vulnerable population is entirely dependent upon caregivers who must be able to trust that the information on the label is truthful and scientifically supported.
The comment period on this draft guidance opens September 9, 2016. Although comments are accepted at any time, to ensure that the agency considers comments on this draft guidance before it begins work on the final version of this guidance, submit either electronic or written comments on the draft guidance by November 8, 2016. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2016-D-2241, as listed in the notice of availability that publishes in the Federal Register.
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