Gerber Hit With Lawsuit Over False Allergy Claims on Infant Formula

Gerber Products Co. has been hit with a lawsuit over health claims on the company’s Good Start Gentle infant formula. The lawsuit, filed in the U.S. District Court for the Eastern District of New York, accuses Gerber of falsely marketing its formula and making allergy-based “health claims” that are not supported by the FDA – even though the products are sold as the “first and only” formula endorsed by the agency to reduce the risk of allergies.

Gerber has already been sued by the Federal Trade Commission for inaccurately labeling its Good Start Gentle formula and making unsubstantiated claims about the product’s ability to prevent allergies. As the FTC wrote in October 2014:

“Parents trusted Gerber to tell the truth about the health benefits of its formula, and the company’s ads failed to live up to that trust. Gerber didn’t have evidence to back up its claim that Good Start Gentle formula reduces the risk of babies developing their parents’ allergies.”

What Has Gerber Done?

In 2009, Gerber petitioned the FDA for permission to make a qualified health claim about allergy prevention on its Good Start Gentle infant formula.

In Gerber’s case, the company wanted permission to state that its formula helped reduce the risk of atopic dermatitis. The claim was based on the fact Good Start Gentle contains partially hydrolyzed whey protein, rather than intact cow’s milk protein found in comparable products – something Gerber believed could help protect children from developing the condition. So far, so good.

What Went Wrong?

In advertising its Good Start formula, Gerber wanted to make a qualified health claim about whey protein. However, the FDA did not accept the evidence submitted, and so rather than approve a qualified health claim, said the company could make the claim as long as it made the lack of evidence clear to consumers. Unfortunately, Gerber didn’t follow the FDA’s instructions. Rather than the narrow claim approved by the FDA (i.e., a health claim about atopic dermatitis, with qualifying statements that made it clear there was “little scientific evidence” for the relationship), Gerber went ahead and included a qualified health claim on its packaging – setting the company on a collision course with the FDA.

What Was The FDA’s Response?

The FDA had previously rejected Gerber’s request to include other qualified health claims promoting the power of whey protein, concluding that “Gerber lacked the scientific substantiation to make these general allergy-prevention claims.” As the newly filed lawsuit puts it:

“The FDA stated that it would only consider exercising its enforcement discretion regarding the atopic dermatitis claim if Defendant modified the claim and included highly qualifying language that ‘very little scientific evidence’ exists to support the link; that such a link has been observed only when infants consumed 100% whey-protein partially hydrolyzed infant formula during the first four months of life; and that the FDA considers any such link to be ‘uncertain’ in light of studies that have found no beneficial relationship.”

Voting to file a federal court complaint last year, the FTC argued that Gerber had gone far beyond the FDA’s instructions, featuring broad statements about “allergies” (rather that atopic dermatitis alone) and placing gold badges on its products that described Good Start gentle as the only formula that “Meets FDA Qualified Health Claim.” In short, as the FTC put it, “Gerber lacked the scientific substantiation to make these general allergy-prevention claims.”

What Does the New Lawsuit Say?

The new lawsuit, filed by plaintiffs Jennifer Hasemann and Debbie Hoth, was filed on behalf of all individuals who have purchased Good Start infant formula in either Florida or Wisconsin and is seeking compensation for customers who bought the products believing the formula would help their children fight allergies. As the lawsuit explains:

“Plaintiff Hasemann began regularly feeding her baby Good Start in May 2012. Plaintiff Hasemann did so after researching Good Start and reviewing statements Defendant made on its website and on the product itself that highlighted Good Start’s supposed endorsement by the FDA and its purported ability to protect infants from developing allergies. Based on Defendant’s deceptive and misleading information, Plaintiff Hasemann purchased falsely labeled 12 ounce Good Start containers from stores in Florida for prices ranging from $16 to $17.”

And, crucially:

“The prices Defendant marketed to Plaintiffs, which Plaintiffs paid, for Good Start were inflated as a result of Defendant’s deceptive and misleading health claims. Plaintiffs would not have purchased Good Start at these inflated prices had they known: (1) that partially hydrolyzed whey protein does not reduce the risk of allergies (including atopic dermatitis) in children and/or (2) that the FDA did not endorse, approve, or certify the health claims Defendant made on its labels, in its advertisements, and on its website.”

This is why the lawsuit has been filed: new parents have been buying Gerber’s infant formula because they believed the company’s claims that Good Start can help prevent childhood allergies, when the truth may be anything but. Infant formula isn’t cheap, and so consumers are now seeking compensation from the company that they trusted to accurately represent its own products. The lawsuit is also seeking “disgorgement” of Gerber’s revenues, meaning the company could lose any profits made by selling the falsely advertised formula.

In a way, the main argument isn’t about whether whey protein actually does help prevent certain allergies in certain conditions, but more about Gerber’s willingness to sell its formula using unsubstantiated statements even after the FDA had told the company not to do so.