FDA WARNING_LETTER - Nestle Healthcare Nutrition

The FDA issued a Warning Letter to Nestle Nutrition regarding its BOOST Kid Essentials Nutritionally Complete Drink, citing misbranding and unapproved new drug violations. The FDA reviewed Nestle's websites (Nestle-Nutrition.com, NestleNutritionStore.com, kidessentials.com) in November 2009, where the product was promoted as a "medical food" for "failure to thrive," "pre/post surgery, injury or trauma, [and] chronic illnesses."

The product is misbranded under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) because it does not meet the statutory definition of a medical food (21 U.S.C. § 360ee(b)(3)) or the criteria in 21 C.F.R. 101.9(j)(8). The FDA states there is no evidence that patients with "failure to thrive" or those "pre/post surgery, injury or trauma, chronic illnesses" have distinctive nutritional requirements that cannot be managed by modifying a normal diet.

Furthermore, the product is deemed an unapproved new drug under section 201(g)(1)(B) and 201(p) of the Act due to therapeutic claims on the websites, such as "[F]or pre/post surgery, injury or trauma, chronic illnesses," and claims about probiotics and antioxidants for various health benefits