reason for its volte‐face on the general folate‐neural tube defect claim highlight the importance of providing a governing rationale for approving or rejecting proposed health claims.
To be sure, Justice Stewart once said, in declining to define obscenity, “I know it when I see it,” which is basically the approach the FDA takes to the term “significant scientific agreement.” But the Supreme Court is not subject to the Administrative Procedure Act. Nor for that matter is the Congress….
That is not to say that the agency was necessarily required to define the term in its initial general regulation—or indeed that it is obliged to issue a comprehensive definition all at once. The agency is entitled to proceed case by case or, more accurately, subregulation by subregulation, but it must be possible for the regulated class to perceive the principles which are guiding agency action. Accordingly, on remand, the FDA must explain what it means by significant scientific agreement or, at minimum, what it does not mean.
….
For the foregoing reasons, we hold invalid the four subregulations, 21 C.F.R. § 101.71(a), (c), (e); § 101.79(c)(2)(i)(G), and the FDA’s interpretation of its general regulation, id. § 101.14. The decision of the district court is reversed, and the case is remanded to the district court with instructions to remand in turn to the FDA for reconsideration of appellants’ health claims.
So ordered.
* * * * *
NOTES AND QUESTIONS
1 5.2. Association versus causation. Many epidemiological studies of dietary intake of conventional foods have led to a promising hypothesis concerning a benefit for a particular nutrient only to subsequently be demonstrated via an intervention study that the nutrient‐containing dietary supplement did not confer a benefit or actually was harmful. For example, a number of studies revealed that diets high in fruits and vegetables containing dietary beta carotene were associated with a lower risk of developing lung cancer, particularly among smokers. Beta carotene is known to be an antioxidant and thus provided a plausible mechanism. However, beta carotene intervention trials absolutely dispelled that hypothesis and even showed there was an increase in lung cancer among smokers after they consumed beta carotene dietary supplements. See Alice H. Lichtenstein & Robert M. Russell, Essential Nutrients: Food or Supplements?: Where Should the Emphasis Be? 294 JAMA 351–358 (2005).
2 5.3. Qualifying weak evidence. The claim requested by Pearson, “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer,” at that time was considered factually accurate but misleading because of the limits in the evidence. The Pearson v. Shalala court indicated that FDA had “logically determined” that the consumption of antioxidant dietary supplements could not be scientifically proven to reduce the risk of cancer. The court, however, concluded that antioxidant vitamins could nevertheless make a cancer prevention health claim if accompanied by a qualification such as, “The evidence is inconclusive because existing studies have been performed with foods containing antioxidant vitamins, and the effect of those foods on reducing the risk of cancer may result from other components in those foods.” Do you agree with the court that the qualifying statement cured the misleading nature of the cancer prevention claim? Do you think the court understood the nature of the scientific evidence?
3 5.4. Hypothesis versus reliable scientific evidence. Of the four claims submitted in Pearson v. Shalala, three involved evidence supporting a hypothesis—in some cases promising support, but nonetheless, no direct evidence to support the claims. Moreover, even if beneficial effect of a component in the food had been determined, there was no evidence that the component would have the same effect if taken as a dietary supplement. In short, there was no reliable evidence to support the claims. Are consumers able to understand the limitations of suggestive evidence when a claim is qualified? Are claims based on unreliable scientific evidence (evidence that is only suggestive of a hypothesis) inherently misleading? What about a qualification where the claim is more likely than not to be invalid? See e.g., “Green tea may reduce the risk of breast or prostate cancer. FDA has concluded that there is very little scientific evidence for this claim.”
4 5.5. Health and safety. The Pearson v. Shalala court noted that the government did not assert that these dietary supplements “in any fashion threaten consumer's health and safety.” Can you think of a way that misleading health claims might adversely affect consumer health and safety?
5 5.6. First Amendment protection for labels versus articles and books. In Pearson, the government argued that the First Amendment rights of food manufacturers were not infringed because the manufacturers could still make their claims in published articles and books. Is the government saying that a label is so inherently different from published articles and books that a different standard for misleading should apply? If not, what is the government implying? Is there different First Amendment protection for labels than for articles and books?
6 5.7. What did Pearson win? Did the Pearson court authorize the plaintiffs to make their claims? What gains did the plaintiffs make?
5.6.4 FDA’s Changes After Pearson
Following the Pearson decision, the FDA announced a number of significant decisions and policy changes regarding its regulation of health claims. In general, these changes provide new flexibility for approval of claims. Food companies now have greater opportunity to communicate information about potential health benefits and specific conventional foods or dietary supplements.
Foremost, FDA now allows “qualified health claims” in the labeling of conventional foods and dietary supplements. The standard for approval for qualified claims shifted from the significant scientific agreement to the weight of scientific evidence. The FDA still requires premarket approval, but has stated that it will “consider” exercising enforcement discretion for a health claim when the following conditions are met:
1 The claim is the subject of an appropriately filed health claim petition.
2 The scientific evidence in support of the claim outweighs the scientific evidence against the claim, the claim is appropriately qualified, and all statements in the claim are consistent with the weight of the scientific evidence.
3 Consumer health and safety are not threatened.
4 The claim meets the general requirements for a health claim in 21 C.F.R. § 101.14.
Note: The first and fourth criteria are requirements found in the FDA regulations cited. The second and third come directly from the court of appeals opinion in Pearson.
5.6.5 The FDA‐Accepted Qualified Health Claims
Examples of some of the qualified health claims accepted by the FDA are as follows40:
Antioxidant Vitamins and Cancer
B Vitamins and Vascular Disease
Calcium and Hypertension, Pregnancy‐Induced Hypertension, and Preeclampsia
Calcium and Colon/Rectal Cancer and Calcium and Recurrent Colon/Rectal Polyps
Chromium Picolinate and Diabetes
Canola Oil Unsaturated Fatty Acids and Coronary Heart Disease
Corn Oil and Corn Oil‐Containing Products and Heart Disease
