FDA WARNING_LETTER - Gerber Products Co

The FDA issued a Warning Letter to Nestle Nutrition regarding misbranded Gerber products. The review covered labels for Gerber Graduates Fruit Puffs and Gerber 2nd Foods Carrots, as well as their website labeling.

The Gerber Graduates Fruit Puffs line is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] due to unauthorized nutrient content claims. These products, intended for infants and children under two (e.g., "crawler" stage), feature claims like "good source of iron, zinc, and vitamin E." FDA regulations (21 CFR 101.13(b)(3) and 21 CFR 101.54) do not permit "good source" claims for foods specifically for this age group, except for established RDI percentages of vitamins/minerals.

Similarly, the Gerber 2nd Foods Carrots product is misbranded under the same section for unauthorized nutrient content claims. Intended for infants under two (e.g., "sitter" stage), its label includes "healthy" ("As Healthy as Fresh"), "Excellent Source ... of Vitamin A," and "No Added Sugar." Regulations (21 CFR 101.65(d), 21 CFR 101.54(b), and 21 CFR 101.60(