Gerber Products Company – FDA Warning Letter

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 Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(r)(1)(A)] due to unauthorized nutrient content claims. Specifically, claims like "good source of iron, zinc, and vitamin E for infants and toddlers" are made, but 21 CFR 101.13(b)(3) and 21 CFR 101.54 prohibit such claims for foods intended for children under two years of age, which these products are (e.g., for "crawler" stage).

Similarly, the Gerber 2nd Foods Carrots product is misbranded under the same section for unauthorized nutrient content claims. Its label includes "healthy" ("As Healthy as Fresh"), "Excellent Source ... of Vitamin A," and "No Added Sugar." While 21 CFR 101.65(d), 21 CFR 101.54(b), and 21 CFR 101.60(c) define these claims, they are not permitted for products specifically intended for children under two (e.g.,