Qualified Health Claims Research Supports Moratorium On Claims – CSPI

"FDA should rescind its approval of all qualified health claims and impose a moratorium on the approval of additional qualified claims" that do not meet significant scientific agreement standards, the Center for Science in the Public Interest argued following a presentation of consumer research on health claims.

The results of research conducted by FDA "indicate that disclaimers do not cure deception created by claims based on emerging science," CSPI Director of Legal Affairs Bruce Silverglade said during a Nov. 17 public meeting on consumer perception of claims.

"Congress concluded that unless claims met the significant scientific agreement standard, consumers would be misled," he maintained. "Given the inadequacy of the disclaimers that have been used so far," FDA should refrain from approving claims that do not meet the SSA standard.

FDA, FTC and the International Food Information Council (IFIC) presented studies during the meeting.

FDA released its comprehensive consumer survey Sept. 29 under the title "Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims" ("The Tan Sheet" Oct. 10, 2005, p. 7).

The studies presented showed a wide range of conclusions on public perception. For example, FDA and the IFIC agreed that qualifiers did little to change consumer perception of a claim and were seldom fully understood.

"Disclaimers have no effect" on lowering public perception, FDA statistician and study co-author Brenda Derby said. "Disclaimers don't work."

However, FTC determined that "qualifying language does change the message consumers take away in our tests," according to Bureau of Economics Associate Director Pauline Ippolito. The commission found that "mean consumer perception of scientific certainty falls with stronger qualifying language."

"It's a somewhat different result from FDA because language here was the main takeaway," Ippolito said.

FTC presented research from a July 2005 working paper entitled, "Consumer Perceptions of Qualified Health Claims in Advertising."

Researchers surveyed consumers on a number of components of health claim presentation. One survey focused on public perception of the scientific certainty behind four claims of varying degrees.

Another section compared FDA disclaimer language to a report card format and a box disclaimer, while another focus tested consumer comprehension of a "fact sheet" on a specific product-disease relationship.

Results were "widely disparate," according to Ippolito.

"Approximately two-thirds of the consumers either overestimated or underestimated the certainty of the science," a study author stated. "It will be a difficult task to craft qualifications in advertising that communicate a low level of scientific certainty."

A West Virginia University study showed consumers found structure/function claims confusing. Researchers conducted a mall interception survey testing structure/function claims with and without DSHEA disclaimers.

"Structure/function claims lead to equivalent beliefs as disease claims," study co-author Karen Russo France, PhD, said. Consumers are "not making any distinction between them." DSHEA disclaimers were found to "not effectively lower beliefs regarding FDA evaluation or product efficacy."

Separately, Ohio State University researchers "discovered significant difference in attitude and confidence but not perceived health benefits" between the use of claims with and without a report card graphic.

FDA announced that two studies were "in the pipeline" to further examine health claims. One will address consumer response to claims for foods rather than substances, i.e. yogurt vs. yogurt containing calcium, and the other will focus on claims language for omega-3s, fatty acids and green tea.

Berna Magnuson, PhD, of the industry consulting firm Burdock Group, proposed a new system for claims evaluation.

FDA should implement use of an "expert panel" that would work with the petitioner to analyze research supporting the claim, she said. The panel would compile the data into a dossier that would include background information on the disease, shifting burden of proof onto the petitioner and panel rather than a resources-strapped FDA, Magnuson maintained.

- Melina Vissat