Emord & Associates is dedicated to serving the needs of its national client base. The firm’s attorneys represent clients in constitutional and administrative law cases before the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Department of Justice (DOJ), the Department of the Interior, the Bureau of Land Management (BLM), the National Park Service (NPS), the Equal Employment Opportunity Commission, the Environmental Protection Agency (EPA), and the Federal Communications Commission (FCC).

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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.


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

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.”

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

B Vitamins and Vascular Disease

Calcium and Colon/Rectal Cancers and Recurrent Colon Polyps

Calcium and Hypertension; Pregnancy Induced Hypertension; and Preeclampsia

Chromium Picolinate and Insulin Resistance

Folic Acid and Neural Tube Defects (and here)

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

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

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

Selenium and Reduced Risk of Site-specific Cancers

Tomatoes and Prostate, Ovarian, Gastric and Pancreatic Cancers

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