# FDA WARNING_LETTER - Nestle Healthcare Nutrition - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/nestle-healthcare-nutrition/4c96d7bf-44c1-4b35-9795-03479b32ea13

> FDA WARNING_LETTER for Nestle Healthcare Nutrition on Unknown Date. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nestle Healthcare Nutrition
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Officers

- [Roberta F. Wagner](https://www.keypedia.com/people/roberta-f-wagner/44ae7da7-afe0-4834-8b96-349a7b07ffbd)

Company: https://www.keypedia.com/companies/nestle-healthcare-nutrition/82acad5e-9c4a-46eb-946d-3f784dddabb6

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2