Last week the FTC sued Gerber Products Co., alleging that it has no basis for asserting that its Good Start Gentle baby formula reduces the risk of infant allergy development and that these health claims were falsely advertised as “FDA Approved.”

Whether to identify products as “FDA Approved” raises important questions for companies considering using qualified health claims. Many companies choose not to make such claims, given the often confusing nature of FDA-required language identifying limited evidence supporting the claims.

FDA requires that a health claim characterize the relationship between a substance (food or food component) and a reduction in risk of contracting a particular disease or health-related condition. To receive FDA approval for health claims, a company must demonstrate “significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship.”

If there isn’t agreement, a company can petition FDA to exercise its discretion to approve narrow or qualified health claims. If the FDA concludes there is credible but limited evidence, the agency will send a letter specifying, among other conditions, the specific language that must be used to communicate to consumers that limited evidence supports a claimed health benefit.

In 2005, Gerber petitioned FDA for approval to make a health claim explaining the relationship between whey-based formula and the reduced risk of kids developing food allergies. The FDA rejected the claim for lack of credible supporting evidence.

In 2009, Gerber petitioned the FDA again, this time asking for permission to use a qualified health claim describing the relationship between Partially Hydrolyzed Whey Protein (“PHWP”) formula and a reduced risk of atopic dermatitis in infants. Specifically, Gerber requested permission to say that “emerging clinical research” shows that PHWP infant formula may reduce the risk of atopic dermatitis.

The FDA again rejected the request but this time issued a letter indicating it would consider exercising its enforcement discretion to allow Defendant to make any number of highly qualified health claims, including 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.” In other words, if Gerber wanted to make the claim, it must clearly communicate to consumers that there is “little scientific evidence” for the relationship.

Despite the very specific language of the letter, Gerber advertises the 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 Complaint alleges that in this context, parents would likely interpret the phrase “1st & Only Meets FDA Qualified Health Claim” to suggest that Good Start Gentle “qualified for or received approval for a health claim” from the FDA – when the facts are exactly the opposite.

An FTC blog post explains that “Gerber was making a play on the word ‘qualified’ to mislead consumers about the FDA’s real assessment. The FDA said the relationship between Gerber’s formula and reduced risk of atopic dermatitis was ‘uncertain’ because there was ‘little scientific evidence’ to support it. So, far from finding this formula worthy of any gold badge, the FDA allowed Gerber to discuss atopic dermatitis only if its claims were highly ‘qualified’ to show the limited science supporting the claim.”

The FTC’s allegations that Gerber Products Co. overstated the ability of Good Start Gentle formula to prevent allergies highlights the difficulty of using qualified health claims, which are often restrictive and difficult for consumers to understand. While the lawsuit was only filed recently, there are general principles marketers may take from well-established FTC case law that will likely be used to adjudicate the matter.

  1. Support health claims with proper science. It is essential to first determine what claims consumers take from the ads and then ensure proper science exists to back up each of those claims.
  2. Make sure you are properly qualifying your “qualified claims”. Experienced attorneys use the phrase “qualified claim” to mean a narrow representation with limited support. But consider how a mom or dad shopping for baby formula or the like would interpret the phrase “FDA Qualified Health Claim.” Make sure you are using the specific language required by the FDA.

When using a claim the FDA has already decided is tentative at best, it’s paramount not to overstate or oversell it, or you could land in court.