At the behest of Durk Pearson and Sandy Shaw, Emord & Associates sued the FDA in the 1990s for refusing Pearson and Shaw’s request to authorize four specific health claims for dietary supplements.  Pearson and Shaw sought agency approval of claims associating antioxidant vitamins with cancer risk reduction; omega-3 fatty acids with vascular disease risk reduction; folic acid with neural tube defect risk reduction; and fiber with colorectal cancer risk reduction.  In particular, Pearson and Shaw argued that if FDA did not approve the claims under its “significant scientific agreement” standard, it nevertheless had to allow them to comply with the First Amendment, resorting to a succinct disclaimer to communicate its doubts about the science supporting the claims.  The FDA refused to allow any of the claims or rely on claim qualification as a less speech restrictive alternative to outright suppression, and our firm, as Pearson and Shaw’s counsel, sued the agency.  That suit resulted in a landmark victory over the FDA before the United States Court of Appeals for the D.C. Circuit in Pearson v. Shalala (1999).

In Pearson v. Shalala, the D.C. Circuit agreed with Pearson and Shaw that FDA was obligated by the First Amendment to favor disclosure with accurate, succinct and reasonable disclaimers over suppression and to rely on claim qualification rather than outright suppression.  That then ultimately led to the FDA’s qualified claim regime, but only after Emord & Associates defeated the FDA several more times in federal court for refusing to abide by the Pearson v. Shalala decision.

Here are the decisions in which the firm defeated the FDA:

Pearson v. Shalala
Pearson v. Shalala, en banc
Pearson v. Shalala II
Pearson v. Thompson
Whitaker v. Thompson I
Whitaker v. Thompson II
Whitaker v. Thompson III

Alliance for Natural Health US v. Sebelius, et al.

Emord & Associates has petitioned the FDA for approximately 100 qualified health claims.  The following claims have been allowed by FDA either directly or after the firm has defeated the agency in federal court:

Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers

• Vitamin C

Gastric (Stomach) Cancer:  “One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.”

• Vitamin E

Bladder Cancer:  “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”

Colorectal Cancer:  “Two weak studies and one study with inconsistent results suggest that vitamin E supplements may reduce the risk of colorectal cancer. However, another limited study showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of colorectal cancer.”

Renal Cell Cancer:  “One weak and limited study suggests that vitamin E supplements may reduce the risk of renal cell cancer. FDA concludes that it is highly uncertain that vitamin E supplements reduce the risk of renal cell cancer.”

Antioxidant Vitamins and Risk of Certain Cancers

• “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”
• “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive.”
• “FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.”

B Vitamins and Vascular Disease

• “As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease.  FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”

Calcium and Colon/Rectal Cancers and Recurrent Colon Polyps

• “Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.”
• “Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps. FDA concludes that there is little scientific evidence to support this claim.”

Calcium and Hypertension; Pregnancy Induced Hypertension; and Preeclampsia

• “Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.”
• “Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during pregnancy. However, three other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension.”
• “Three studies, including a large clinical trial, do not show that calcium supplements reduce the risk of preeclampsia during pregnancy. However, two other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of preeclampsia.”

Chromium Picolinate and Insulin Resistance

• “One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.”

Folic Acid and Neural Tube Defects (and here)

• “0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form. FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects.”
• “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. The Institute of Medicine of the National Academy of Sciences recommends that women capable of becoming pregnant consume 400 mcg folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet.”
• “Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. The scientific evidence that 400 mcg folic acid daily reduces the risk of such defects is stronger than the evidence for the effectiveness of lower amounts. This is because most such tests have not looked at amounts less than 400 mcg folic acid daily.”
• “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 folate/day from fortified foods and/or a supplement, in addition to food folate from a varied diet. It is not known whether the same level of protection can be achieved by using only food that is naturally rich in folate. Neither is it known whether lower intakes would be protective or whether there is a threshold below which no protection occurs.”
• “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.”

Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease

• “It is known that diets low in saturated fat and cholesterol may reduce the risk of heart disease. The scientific evidence about whether folic acid, vitamin B6 and vitamin B12 may also reduce the risk of heart disease and other vascular diseases is suggestive, but not conclusive. Studies in the general population have generally found that these vitamins lower homocysteine, an amino acid found in the blood. It is not known whether elevated levels of homocysteine may cause vascular disease or whether high homocysteine levels are caused by other factors. Studies that will directly evaluate whether reducing homocysteine may also reduce the risk of vascular disease are not yet complete.”

Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease

• “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.  One serving of [Name of the food] provides [  ] gram of EPA and DHA omega-3 fatty acids.  [See nutrition information for total fat, saturated fat, and cholesterol content.]”

Phosphatidylserine and Cognitive Dysfunction and Dementia (and here and here)

• Dementia:  “Consumption of phosphatidylserine may reduce the risk of dementia in the elderly.  Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”
• Cognitive dysfunction:  “Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”

Selenium and Reduced Risk of Site-specific Cancers

• Bladder Cancer:  “One study suggests that selenium intake may reduce the risk of bladder cancer in women.  However, one smaller study showed no reduction in risk.  Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women.”  
• Prostate Cancer:  “Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”
• Thyroid Cancer:  “One weak, small study suggests that selenium intake may reduce the risk of thyroid cancer. Based on this study, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of thyroid cancer.”

Tomatoes and Prostate, Ovarian, Gastric and Pancreatic Cancers

• Prostate Cancer:  “Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.”
• Gastric Cancer:  “Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.”
• Ovarian Cancer:  “One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer.”
• Pancreatic Cancer:  “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.

Information sourced directly from Emord and Associates.

Emord & Associates has extensive experience in prosecuting health claim petitions before the FDA.  Indeed, the qualified health claim regime at FDA is a result of the landmark decision reached in Pearson v. Shalala (1999) in which the firm served as lead counsel for the victorious plaintiffs. http://emord.com/firm-profile/health-claims/