WASHINGTON (CN) – A federal judge ruled that the FDA may indeed bar diet-supplement makers from claiming that their products may reduce the risk of cancer.
U.S. District Judge Beryl Howell, who recently ruled against the same supplement makers in a fight over manufacturing regulations, said the FDA must reword its disclaimers on vitamin C and vitamin E products that claim to fight gastric and bladder cancers, but agreed with the FDA that supplement makers cannot claim that the same vitamins reduce the risk of colon and lung cancers.
Diet-supplement makers Durk Pearson and Sandy Shaw, and the Alliance for Natural Health U.S. and the Coalition to End FDA and FTC Censorship sued the FDA after the agency refused to allow such claims to be made on their products. They claimed the FDA had violated their right to commercial free speech.
According to the ruling, the FDA barred outright any claims that vitamins C and E reduce the risk of lung and colon cancer. The agency said that scientific evidence supporting such claims is convincing, but not conclusive.
The FDA allowed claims that the vitamins may reduce the risk of gastric and bladder cancers, but only with disclaimers that state: “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer …” and “One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer.”
The disclaimers also state that other studies show no correlation between the supplements and cancer risk reduction.
“The FDA’s rewording makes it difficult to tell what the original health claims are and appears to disavow the FDA’s own conclusions that those claims are supported by credible evidence,” the judge wrote.
Judge Howell granted in part and denied in part each parties’ motion for summary judgment, denying supplement makers’ claims that their products may reduce the risk of certain cancers, and remanding the gastric and bladder cancer claims to the FDA for rewording.