a time when there is an aging, health‐conscious population, the ability to make a health claim on a food product is a substantial marketing tool. Recent studies of consumer understanding of food health claims show mixed results. Nutrient content claims help consumers avoid negative nutrients, increase consumption of positive nutrients, but the permitted health claims appear less helpful.51
Text sentences with adjectives appear to incorrectly convey the strength of the science.52 On the other hand, FDA’s A, B, C, D rankings (the “report card grades”) appeared easier for consumers to understand, and they conveyed the relative strength of the scientific support for claims, but consumers may misunderstand qualified claims as having greater product confidence than claims with no qualification (those with greater scientific significance).53 In addition, health claims give consumers a general perception that a product is healthier, but only provide a weak increase in disease risk perception.54
The strength of the disclaimers or qualifications did not significantly diminish consumer perceptions of the health benefits. Conversely, statements conveying more scientific certainty about a claim can create a negative perception by consumers and lower confidence in the health benefits.55 The perturbing result may be explained by the phenomenon of psychological reactance, where people react negatively to a perceived inappropriate attempt to influence them.56 A fundamental problem with qualifications on claims is not just a problem with comprehension, but also that consumers appear to be exercising skepticism on disclaimers the same as they do advertising puffery.57
This situation creates controversy among nutrition policy experts.58 In addition to perturbing results with disclaimers, some experts are concerned that the prolific spinning of weak qualified claims may crowd out the claims with scientifically significant support.59 Thus, even when understood, qualifying statements may have unexpected results on consumer behavior and understanding of health benefits. Some believe that allowing marginal health claims creates misleading labels and less information for consumers, adding noise instead of clarity and undermining credibility of regulatory statements.60
Ironically, this is nearly exactly the position that FDA took in the Pearson v. Shalala case years before; in particular that “consumers would be considerably confused by a multitude of claims with differing degrees of reliability.”61 The Pearson court objected to the fact that FDA had not even considered disclaimers in the context of evaluating health claims. Further, FDA merely offered its own conclusory opinion without empirical evidence of consumer confusion. This recent research provides the exactly the type of empirical evidence that FDA needed to back up its opinion in the Pearson case.
FDA took the Pearson decision as a rebuke. Afterward, the agency retreated from its earlier position on health claims. Now, FDA appears unwilling to do more than reject those claims that totally lack scientific support. Nonetheless, the recent research points in the direction that FDA’s hunches ten years ago about health claim confusion were correct.
Having been stung by the Pearson decision, FDA is unlikely to change its current stance on modified claims without outside pressure. However, Pearson did not require FDA accept qualified health claims. The Pearson decision only directed FDA to consider whether qualifications could cure a misleading claim, the agency was not prevented from prohibiting misleading claims or prohibiting misleading claims that could not be cured by disclaimer language.62
NOTE AND DISCUSSION
1 5.11. Balancing regulation and consumer protection. FDA has taken significant steps to ensure it does not unnecessarily restrain commercial speech. However, history provides examples of excessive and unsubstantiated claims, which would indicate close regulation is required. On the other hand, there is evidence that increased access to health information plays a useful role in helping consumers make informed choices for good health. These forces play against each other. Do you think FDA achieved the proper balance?
5.7 SUBSTANTIATION OF CLAIMS
5.7.1 FDA’s Evidence‐Based Review System
FDA’s evidence‐based review system of health claims involves a systematic science‐based evaluation to determine the strength of the scientific evidence to support a proposed claim about a substance–disease relationship. FDA evaluation of the scientific evidence for health claims includes the following steps:
Identify scientific studies that evaluate the substance–disease relationship.
Identify surrogate endpoints of disease risk.
Evaluate human studies.
Assess the methodological quality of the scientific studies.
Evaluate the totality of the scientific evidence.
Assess significant scientific agreement.
As a preliminary matter before evaluating the science, to determine what information is needed to substantiate a claim, one must first identify and understand the meaning of the claim, expressed and implied. Clearly understanding a claim’s meaning is crucial in identifying the appropriate study hypotheses and measurable endpoints needed to substantiate the claim.
Next, a threshold review of the studies and other evidence is needed to determine whether they have a relationship to the claim. Did the study specify and measure the ingredient that is the subject of the claim? For example, a study only measuring carrot consumption will not support a claim about carotene consumption. Did the study specify and measure the affect that is the subject of the claim? That is, an appropriate endpoint needs to be measured to evaluate the effect.
Then the scientific quality of the evidence must be determined. The criteria of scientific quality include the study type, the study population, the study design and conduct (e.g., presence of a placebo control), data collection, statistical analysis, and outcome measures. High‐quality scientific study adequately addresses all or most of the above criteria.
Finally, whether there is adequate evidence to substantiate a claim is based on the strength of the entire body of evidence. Ideally, the evidence has been replicated in independent studies and is supported by the surrounding body of evidence. However, there is no rule on the number of studies needed or what combination of evidence is sufficient to support a claim because of the diverse nature of various studies. The quality and quantity of the studies and their consistency and relevancy matter. Conflicting or inconsistent results raise serious questions as to whether a particular claim is substantiated. All of the evidence must be weighed in totality.
* * * * *
Guidance for Industry Evidence‐Based Review System for the Scientific Evaluation of
