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
Cranberry Juice Beverages and Cranberry Dietary Supplements and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women
EHA and DHA and Reduction of Blood Pressure in the General Population
Folic Acid 0.8 mg and Neural Tube Birth Defects
Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease
Green Tea and Cancer
Ground Peanuts and Reduced Risk of Developing Peanut Allergy
Nuts and Coronary Heart Disease
Olive Oil Monounsaturated Fatty Acids and Coronary Heart Disease
Oleic Acid and Coronary Heart Disease
Omega‐3 Fatty Acids and Coronary Heart Disease and Hypertension (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega‐3 fatty acids)
Phosphatidylserine and Cognitive Dysfunction and Dementia
Selenium and Cancer
Soybean Oil and Reduced Risk of Coronary Heart Disease
Tomatoes and/or Tomato Sauce and Prostate, Ovarian, Gastric, and Pancreatic Cancers
Walnuts and Coronary Heart Disease
Whole Grains and Diabetes Mellitus Type 2
Each accepted qualified health claim includes specific standards that a food must meet in addition to the general requirements for the claim. For example, a food with a heart claim may not exceed disqualifying levels of saturated fat and so forth. Some of the qualifications regarding the strength and weakness of the evidence are elaborate; for instance, the sample qualified claim below:
One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.41
NOTES AND DISCUSSIONS
1 5.7. Lengthy qualifications. How likely are food distributors to use long and elaborate qualified health claims?
2 5.8. Unreliable scientific evidence. When a qualification for a claim indicates that it is more likely than not to be invalid, is the qualification enough to cure the misleading element? What about a qualified claim where the evidence is unreliable? 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.” Do such qualified claims prevent consumers from being misled?
5.6.6 The Pearson Claims Revisited
Regarding the particular health claims proposed by the Pearson plaintiffs, the FDA developed “qualified” claims that would be appropriate on food labeling, even in the absence of evidence meeting the “significant scientific agreement” standard.
One of the agency’s qualified claims for folate is:
Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg of folate per day from a supplement or fortified foods and consume food folate from a varied diet. It is not known whether the same level of protection can be achieved by using lower amounts.
The agency’s qualified claim for omega‐3 fatty acids and CHD is:
The scientific evidence about whether omega‐3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish, and it is not known whether diets or omega‐3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega‐3 fatty acids may or may not have on risk of CHD in the general population.
Regarding dietary fiber, the FDA found no basis to conclude that the available evidence permitted a comparably nonmisleading use of qualified information. Regarding the antioxidants