December 26, 2009
The U.S. Food and Drug Administration has sent a warning letter to Nestle HealthCare Nutrition, admonishing it against promoting its BOOST Kid Essentials Nutritionally Complete Drink as a medical food.
The letter said the company has improperly labeled the dirnks on its Web site as treatment for the medical condition failure to thrive. The FDA said under regulations, the product is mis-branded because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food under the Orphan Drug Act.
The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease, the letter states. The marketing of this product with these claims violates the Act.
The Orphan Drug Act defines "medical food" as "a food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
FDA said it considers the statutory definition of "medical food" to narrowly constrain the types of products that fit within this category. In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.
There is no evidence that patients with the medical condition of "failure to thrive" have distinctive nutritional requirements or unique nutrient needs, as required by the statute, the FDA said. No established distinctive nutritional requirement exists for the conditions for which your product is promoted as a medical food, and your BOOST Kid Essentials Nutritionally Complete Drink product therefore does not meet the statutory or regulatory definition of a medical food. Accordingly, your product is misbranded.
In a separate letter, the FDA warned Nestle that it had made unauthorized nutrient content claims about Juicy Juice Brain Development Fruit Juice Beverage, Juicy Juice All-Natural 100% Juice Orange Tangerine and Juicy Juice All-Natural 100% Juice Grape. The agency said Nestle used the statement "no sugar added" on the brain development drink. That type of claim is not permitted for foods intended for children under age 2, the letter said.