NEWARK, N.J. (CN) - The makers of Gerber Good Start Gentle formula cannot substantiate claims that the product prevents infants from developing allergies, federal regulators say.
On the heels of class actions advancing similar claims across the county, the Federal Trade Commission sued Gerber Products Co. on Wednesday for a permanent injunction and disgorgement of ill-gotten money.
Gerber and its Nestle subsidiary have marketed the baby formula at issue since 2011, according to the complaint.
The FTC called it "false or misleading" for Gerber to say that the Food and Drug Administration has already approved Gerber Good Start Gentle "for a health claim," or to say that the formula qualified for such approval.
Gerber has no basis to purport that its Good Start formula prevents or reduces the risk of allergies in infants with a family history, the complaint states.
The baby-food giant called the FTC's complaint disappointing.
"We are defending our position because we believe we have met, and will continue to meet, all legal requirements to make these product claims," Gerber said in a statement.
Though the company bases its claim on its product's "partially hydrolyzed whey protein" content, the FTC noted that the FDA refused back in 2005 to give Gerber "a health claim explaining the relationship between partially hydrolyzed whey protein ('PHWP') infant formula and reduced risk of food allergies in infants." (Parentheses and emphasis in original.)
The FDA said there was "no credible" evidence for the assertion, and it also rejected a 2009 petition to let Gerber "use a qualified health claim describing the relationship between PWHP infant formula and reduced risk of atopic dermatitis in infants," according to the complaint.
Gerber countered Thursday that "extensive, peer-reviewed scientific evidence supports the role of 100% whey partially hydrolyzed infant formula in reducing the risk of atopic dermatitis, commonly known as baby eczema, in infants with a family history of allergy."
"Further, Gerber has been authorized by the U.S. Food & Drug Administration (FDA) to feature a qualified health claim based on this evidence," the company added.
But the FTC says that the FDA warned that "enforcement" action could follow to let Gerber "make a highly qualified health claim that 'the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship."
"Notwithstanding the FDA's letter of enforcement discretion, defendant advertises its Gerber Good Start Gentle infant formula with, among other things, a circular gold seal or badge emblazoned with '1st and Only' in the center, 'Meets FDA' in the top perimeter, and 'Qualified Health Claim' in the bottom perimeter," the FTC says.
In addition to those badges and seals, the 14-page complaint recites a series of print advertisements and television spots that advance Gerber's claims about the supposed benefits of Good Start formula.
Gerber sells its powdered Good Start formula in a 23.2-ounce container for $24, and bills it as "easier to digest than formula made with intact cow's milk protein," the FTC notes.
Both the "false FDA approval claim," and the "false or unsubstantiated allergy claim" violate the FTC Act, according to the complaint.
FTC attorney Victor DeFrancis of Washington, D.C., signed the action.
In the same court, U.S. District Judge Jose Linares is presiding over a consolidated class action over Gerber probiotic forumala.
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