FDA WARNING_LETTER - Pbm Products, LLC

The FDA issued a Warning Letter to PBM Products, LLC, regarding misbranded Parent's Choice Little Puffs products. The review focused on the labels of "Parent's Choice Little Puffs Plus Calcium Blueberry Naturally Flavored" and "Parent's Choice Little Puffs Made With Whole Grains Peach-Mango Naturally Flavored."

Both products are misbranded under section 403(r)(1)(A) of the Act [21 USC 343(r)(1)(A)] due to unauthorized nutrient content claims for foods intended for infants and children under two years of age, which is prohibited by 21 CFR 101.13(b)(3). Specifically, the "Plus Calcium" claim on the Blueberry product and "Good source of calcium," "Good source of Vitamin D," and "Good source of Iron" claims on the Peach-Mango product are not permitted for this age group.

Additionally, the Peach-Mango product is misbranded under Section 403(q) of the Act [21 USC 343(q)] because its nutrition facts information violates 21 CFR 101.9. Deficiencies include listing saturated fat, cholesterol, and calories from fat (21 CFR 101.9(j)(5)), and incorrect formatting of the dual column for % Daily Value for "Infants 0-1" and "Children 1-4," which