FDA WARNING_LETTER - First Juice

The FDA issued a Warning Letter to First Juice, Inc. CEO David Glasser regarding their Organic Fruit and Veggie Juice Beverage line, including apple + carrot, banana + carrot, blueberry + purple carrot, and peach + purple carrot products. The letter, dated CFSAN-OC-10-13, states that the products are misbranded under the Federal Food, Drug, and Cosmetic Act.

The primary violation is that the products are intended for infants and children under two years of age, as indicated by labeling statements like "fruit and vegetable juice for infants and toddlers" and dual nutrition labeling for children 6-12 months and over 12 months. However, the product labels and website (www.firstjuice.com) bear unauthorized nutrient content claims, such as "plus calcium" and "50% less sugar." Under 21 CFR 101.13(b)(3), nutrient content claims are generally not permitted for foods intended for children under two unless specifically authorized, which these claims are not.

Additionally, the blueberry + purple carrot and peach + purple carrot products are further misbranded due to unauthorized health claims. The website claims purple carrots "reduce[ ] risk of cancer and stroke" and "guard against heart disease and some cancers." These are considered implied health claims about the food itself and are not authorized by the Act or FDA regulations, nor has FDA issued enforcement discretion for them.

First Juice, Inc. is required to