FDA Calls Nestlé Products Misbranded

In a letter recently posted to its website, the Food and Drug Administration (FDA) has warned Nestlé USA that its Juicy Juice® products are misbranded because their labels include “unauthorized nutrient content claims.” According to FDA, the product labels include the claim “Helps support brain development . . . In children under two years old” and also states “no sugar added.” Under FDA regulations, these statements cannot be made on products for children younger than age 2.

FDA also states that other Nestlé products have misleading labels because they imply that they contain 100 percent natural fruit juice when they actually contain “Flavored juice blend from concentrate with other natural flavors & added ingredients.”

In a separate letter, FDA warns that the company’s BOOST Kid Essentials Nutritionally Complete Drinks® are also misbranded because they are promoted as a “medical food” to address conditions such as “failure to thrive” and “pre/post surgery, injury or trauma, chronic illness.” Without any evidence to show that these conditions have unique nutrient needs, FDA contends that the product is not a “medical food”
nor is it a drug, although it is being promoted that way. Without FDA approval, the product cannot be marketed as a drug.

In both letters, the agency calls for a response within 15 days with “the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.”