The FDA said Nestlé Healthcare Nutrition’s Your BOOST Kid Essentials Nutritionally Complete Drink (vanilla, chocolate and strawberry flavors) was being promoted as a medical food for "failure to thrive" and also for "pre/post surgery, injury or trauma, chronic illnesses."
The products did not have medical foods approval under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [the Act] and definitions as laid out in 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 marketing of this product with these claims violates the Act,” wrote the FDA’s Roberta F Wagner, director in its office of compliance at the Center for Food Safety and Applied Nutrition.
Nestlé USA received another letter for Juicy Juice varieties, which the FDA said was also being misbranded under section 403 of the Act.
The FDA said Juicy Juice Brain Development Fruit Juice Beverage (Apple) was making unauthorized nutrient content claims by linking vitamin and mineral levels with brain health claims such as, "Helps support brain development in children under two years old".
A “no sugar added” claim was also challenged because such claims cannot be made on products aimed at children under the age of two.
Juicy Juice All-Natural 100% Juice Orange Tangerine, and Juicy Juice All-Natural 100% Juice Grape were challenged because the juices, while being 100% juice, were not 100% of the same juice listed on the label.
In both cases, Nestlé has 15 days to inform the FDA of its corrective actions, or reasons why it may take longer to bring its products within the law.
“Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction,” Wagner wrote.
In regard to the BOOST products, medical foods are defined as those which:
- Are specially formulated and processed for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube
- It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone
- Provide nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation
- Are intended to be used under medical supervision
- Are intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
“There is no evidence that patients with the medical condition of ‘failure to thrive’ have distinctive nutritional requirements or unique nutrient needs,” Wagner wrote, noting the same was true for the, "pre/post surgery, injury or trauma, chronic illnesses" claim.
Nestlé spokesperson Pam Krebs told NutraIngredients-USA.com the company was fully cooperating with the FDA on the matter.