FDA should study consumer perceptions of qualified health claims by testing statements that contain both "report card" grades and text ratings, as well as claims that do not bear a letter grade, the Consumer Healthcare Products Association says in recent comments to the agency.

CHPA's Dietary Supplements Committee "question[s] whether a report card graphic is an appropriate method for communicating the level of scientific support for QHCs to consumers." The committee is specifically concerned that "personal biases" about specific letter grades could affect perception about a product or ingredient.

The June 21 submission responds to a May 22 Federal Register notice which proposed further evaluation of qualified health claims through a consumer study (¹ 'The Tan Sheet' May 22, 2006, In Brief).

The agency has been working to understand how consumers interpret label information about the level of scientific support for claims and whether they trust qualifying statements.

In October, FDA released results of a study showing that consumers were more likely to doubt health claims with the highest level of scientific support than those bearing disclaimers (² Also see "Qualified Claims Language And Grading Confuses Consumers – FDA Study" - Pink Sheet, 10 October, 2005., p. 7).

Due to the results of the study, the CHPA committee recommends that FDA test the "use of qualifying language consistent with the highest level of science support in significant scientific agreement health claims so that it can be determined whether the presence of a qualifier increases consumers' perceived credibility of the message."

For example, it could be beneficial to measure consumer reactions when a statement such as "Very strong, conclusive evidence shows..." is added to a claim backed by a strong level of science, CHPA states.

FDA intends to test claims linking green tea to cancer reduction that are heavily qualified. One claim reads: "One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer." The claim was approved by FDA in July 2005 (³ Also see "Green Tea Cancer Prevention Claims Offered By FDA Stress Data Limits" - Pink Sheet, 11 July, 2005., p. 12)

Qualified claims that link omega-3 fatty acids and olive oil to coronary heart disease reduction also will be tested.

The omega-3 claim was approved by FDA in September 2004 and states, "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease" (⁴ Also see "Industry Qualifies Enthusiasm For Omega-3 Qualified Health Claim" - Pink Sheet, 13 September, 2004., p. 12).

The olive oil claim reads: "Limited and not conclusive scientific evidence suggests that eating about two tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to monounsaturated fat in olive oil."

In the meantime, FDA is working to better inform industry about the process for petitioning for a qualified health claim. In May, the agency issued a final guidance entitled "FDA's Implementation of 'Qualified Health Claims.'"

The guidance covers questions such as "How are health claims different from structure/function claims?" and "What is a letter of enforcement discretion?" The guidance also explains how to submit a petition and the type of information that should be included.

The document does not provide any suggestions regarding the number or types of studies that should be submitted to support claims. However, Barbara Schneeman, PhD, of the Center for Food Safety & Applied Nutrition, recently advised that companies read letters of enforcement discretion in order to gain a sense of what constitutes a successful QHC submission (⁵ Also see "QHC Letters Preview Final Guidance; “Read Them,” Stresses Schneeman" - Pink Sheet, 27 February, 2006., p. 7).

The agency has expressed that quality is more important that quantity when it comes to studies that support health claim petitions.

- Bridget Behling

Qualified Health Claim Study Should Test Letter Grades, SSA Claims – CHPA

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