FDA Warns Misbranded
Nestle, the Swiss food giant, made misleading claims about the health benefits of Juicy Juice products, the FDA says in a December 4 letter to the company.
Juicy Juice is marketed for kids under the age of two.
In a separate letter the day before, the FDA claims the company also promoted its Nestlé’s Boost Kid Essentials Nutritionally Complete Drink as a “medical food” even though it did not meet the requirements for that claim.
The December 4 Warning Letter said that Juicy Juice Brain Development Fruit Juice Beverage (Apple) violates the Federal Food, Drug, and Cosmetic Act and is misbranded because it has “unauthorized nutrient content claims.”
The FDA also has problems with the claim “no sugar added” calling that "misbranded", as well as the content labels for Nestlé’s orange tangerine and grape juice because they claim to be 100 percent juice.
The FDA does not allow brain development and sugar claims to be made for products for children under the age of two.
The FDA also does not allow a “medical food” claim for a food instead requiring it to be approved as a drug.
“Medical foods” are intended to be consumed under the supervision of a physician for the dietary management of a disease or condition, and regulates those foods under the Orphan Drug Act.
“There is no evidence that patients with the medical condition of “failure to thrive” have distinctive nutritional requirements or unique nutrient needs,” says the agency. Nestle says the food is for the medical condition of “failure to thrive” and also for pre-and-post surgery, injury, or trauma.
Nestle needs to submit its claims and products as a new drug that can be marketed in the U.S. only after it has submitted scientific data to the FDA to demonstrate the drug is safe and effective.
Nestle claimed in an April launch of its new Juicy Juice Brain Development is the only “fruit juice beverage on the market currently offering DHA, which makes it a great first juice beverage choice for 1-2-year-olds. DHA acts as a building block for brain development during a child’s first two years of life when their brains triple in size, and experts often recommend infant formula fortified with DHA for children who are not breast feeding.”
Under the leadership this year of Commissioner Margaret Hamburg and deputy Joshua Sharfstein, the FDA has been cracking down on health claims and advertising to consumers. The FDA can seize products if the company does not respond within 15 days. #