FDA warns against feeding dietary supplement product to infants

FDA Consumer, May-June, 2004

The FDA is warning consumers that a product, Better Than Formula Ultra Infant Immune Booster 117, sold over the Internet as a dietary supplement, should not be fed to infants.

NSP Research Nutrition of Mt. Clemens, Mich., sells the product as a dietary supplement. However, as a result of its labeling claims, the FDA is concerned that the product may be used as an infant formula. The term "Better Than Formula" in the product name describes this product as a substitute for, or alternative to, other infant formulas.

In addition, the "mixing instructions and directions" printed on the label state, "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 many other promotional claims that appear to describe this product as an infant formula.

Under the Federal Food, Drug, and Cosmetic Act, "infant formula" is a food that claims to be for special dietary use solely as a food for infants because it is suitable as a substitute for human milk. Better Than Formula Ultra Infant Immune Booster 117 has not been reviewed as an infant formula by the FDA. If it is used as an infant formula, there are no assurances that its nutritional value and safety as an in rant formula are known. In addition, the label lists a number of ingredients that have not been evaluated for safe use in infant formula.

No illnesses or injuries to date have been reported to the agency, but consumers are advised to contact their health care providers if they have any concerns about possible health problems or illness of their babies.