News Update: FDA to Nestle: beverages are misbranded

January 1, 2010

The Food and Drug Administration (FDA) issued a pair of warning letters to Nestle in December 2009 regarding product misbranding.

The Food and Drug Administration (FDA) issued a pair of warning letters to Nestle in December 2009 regarding product misbranding. In a letter to Nestle HealthCare Nutrition regarding Boost Kid Essentials Nutritionally Complete Drink (vanilla, chocolate, and strawberry flavors), the FDA stated that the company's Web site promoted the drink as a "medical food" for the medical condition of "failure to thrive" and for "pre/post surgery, injury or trauma, [and] chronic illnesses." The agency said that the product is misbranded, as it is marketed as a medical food but does not meet the definition of a medical food as established by the FDA.

The FDA took exception with several claims in the product's labeling that promoted the product as a drug, including the following statements: "If your child has stomach problems, such as diarrhea caused by antibiotics, probiotics [an ingredient contained in the product] may help rebuild a healthy colony of good bacteria"; antioxidants found in the product "can help kids fight off sickness at school, the playground, at home, or anywhere on-the-go"; and clinical benefits of the product include "reducing number of days with viral diarrhea, reducing the risk of necrotizing enterocolitis."

In a separate letter, the FDA stated that the company's Juicy Juice Brain Development Fruit Juice Beverage (Apple), Juicy Juice All-Natural 100% Juice Orange Tangerine, and Juicy Juice All-Natural 100% Juice Grape were misbranded. The agency said that the product labeling for the Brain Development Fruit Juice Beverage claimed that the drink "helps support brain development in children under 2 years old," and has "no sugar added." According to FDA regulations, a nutrient content claim cannot be made for a product intended for use by children aged younger than 2 years unless specifically permitted by FDA rules. The FDA stated that the Orange Tangerine and Grape beverages were also misbranded, as their labels implied that the products contained 100% orange/tangerine juice and 100% grape juice, respectively, but the predominant juice in the drinks is neither orange/tangerine nor grape.