In November, FDA will be releasing a report on its consumer research of qualified health claims titled, “Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims.” As part of its research, FDA enlisted 1920 volunteers who were 18 years of age or older. The volunteers were selected from five different shopping malls across the U.S. Participants had to be responsible for at least half of the household food shopping and be able to read words in the required print size. For the experiment, researchers selected four hypothetical dietary substance/disease relationships (calcium/osteoporosis, omega 3 fatty acids/heart disease, selenium/cancer, and lycopene/cancer) to represent a range of scientific certainty. (These “health claims” do not necessarily reflect authorized health claims allowed under FDA regulations or qualified health claims already considered by the agency.) For each hypothetical health claim, researchers also identified an everyday food product that contained the identified nutrient and met all or most qualifying and disqualifying criteria for other nutrients (i.e., calcium/orange juice, omega 3/tuna, selenium/eggs and lycopene/spaghetti sauce). Participants were shown mockup labels for familiar types of products (orange juice, tuna, eggs and tomato sauce) that carried an appropriate health claim for the product presented. The findings from the FDA study suggest:

• Qualifying statements that used only words to convey the strength of science underlying a claim were not understood by consumers.

• Qualifying statements that included a “report card grade” were understood by consumers to convey a rank order of the strength of science underlying a claim, but “B” grades were understood to convey greater scientific certainty than unqualified health claims (i.e., claims that meet the significant scientific agreement standard). (In the FDA consumer research study, FDA did not use an “A” letter grade for the experimental conditions representing claims that met the significant scientific agreement standard, but simply stated the substance/disease relationship.)

• Even when qualified health claims were understood as intended, qualifying statements had unexpected effects on consumers’ judgments about the health benefits and overall healthfulness of the product bearing the claim. Sometimes, these qualified health claims led to more positive product perceptions.

FDA intends to hold a public meeting in mid-November to discuss the qualified health claims study it conducted, as well as other related studies. This public meeting will provide an opportunity for attendees to provide comment to FDA on the new research findings.