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In the Federal Register of October 6, 2000,⁴⁵ the FDA issued guidance on qualified health claims in the labeling of conventional foods and dietary supplements. FDA also republished this information as a guidance document for industry and expanded to include conventional foods along with dietary supplements.⁴⁶ The document sets forth criteria for when the agency allows a qualified health claim in labeling. In addition, FDA states that the agency will use the “reasonable consumer” standard in evaluating food labeling claims. Use of this standard makes the FDA’s regulation of food labeling consistent with the FTC’s regulation of advertising for these products.

FDA noted that consumers are more likely to respond to health messages in food labeling if the messages are specific with respect to the health benefits associated with particular substances in the food. According to the Bureau of Economics Staff of the Federal Trade Commission (FTC),⁴⁷ “consumers are not as responsive to simple nutrient claims” as they are to health claims. FDA stated that in the aggregate, decisions by individual consumers to incorporate beneficial foods into their diets improve public health, “By making clear the lawfulness of conventional foods labeled with truthful and non‐misleading health claims, FDA believes that this guidance will precipitate greater communication in food labeling of the health benefits of consuming particular foods, thereby enhancing the public’s health.”⁴⁸

In its “Better Nutrition Information for Consumer Health Initiative,” FDA has “acknowledged that consumers will benefit from more information on food labels concerning diet and health and this, in turn, has prompted the agency to establish interim procedures whereby ‘qualified’ health claims can be made not only for dietary supplements but for conventional foods as well… . FDA began considering qualified health claims under its interim procedures September 1, 2003.”⁴⁹

To sum up key provisions for use of qualified health claims:

 All health claims must undergo review by FDA.

 All unqualified health claims must meet the Significant Scientific Agreement standard.

 Qualified health claims must be accompanied by a disclaimer or otherwise “qualified” in a way as to not mislead consumers.

 Proposed new qualified claims must be submitted by petition to the FDA. (The procedures for submitting a proposed qualified health claim petition are available on the FDA website.)

 FDA review of qualified health claim petitions results in an FDA letter concerning the use of enforcement discretion for a qualified health claim or denying the qualified health.

 All letters of enforcement discretion are posted on the FDA website, and once posted, all manufacturers receive the same enforcement discretion on the use of the qualified health claim.

 Qualified claims must follow any limits and conditions specified in the FDA letter of enforcement discretion.

Did FDA Go Too Far After Pearson? ⁵⁰

At 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