In addition, the "mixing instructions and directions" printed on the label state that "As with adults, infants should have small feedings every 2 to 3 hours throughout the day and should never be overfed." This statement appears to represent the product for use as a meal and not as a dietary supplement. There are a myriad of other promotional claims that appear to describe this product as an infant formula.
Under the Federal Food, Drug, and Cosmetic Act, the term "infant formula" means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk." Any infant formula marketed must be registered with the FDA at least 90 days before marketing.
The manufacturer has not submitted a notification required under Section 412 of the Federal Food, Drug, and Cosmetic Act for use of this product as an infant formula. If this product is used as an infant formula, there are no assurances that have been provided to the agency by the manufacturer that this product as represented for use 1) would support growth of infants, 2) contains nutrients essential for infants that are required by law in infant formulas, and 3) is manufactured under good manufacturing practices. In addition, the label lists a number of ingredients that have not been evaluated for safe use in infant formula.
"Since the product has not been reviewed as an infant formula, its nutritional value and safety as an infant formula are unknown," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We urge parents who have purchased this product to immediately stop feeding it to their infants."
To date, FDA is not aware of any illnesses or injuries associated with this product. FDA advises that consumers contact their health-care provider if they have any concerns about possible health problems or illness of their infant.
[Source: FDA press release]