FDA Reviews Expanded Claims on Health Benefits of Certain Foods

Extract

After 5 years of legal wrangling and U.S. Food and Drug Administration red tape, food makers may soon be shipping soy products that announce their propensity for reducing the risk of certain cancers.

The FDA already allows a few food–cancer claims about diets that reduce the risk of cancer—those low in fat, high in fiber, or high in fruits and vegetables. These claims pass the FDA's standard of “ significant scientific agreement.”

But a court ruling has lowered the evidence bar, meaning that claims without ironclad support can now appear on food packaging. “It was basically a free speech case,” said Todd Hamilton, J.D., who advises food companies on FDA regulations at the Washington, D.C., law firm Buchanan Ingersoll, PC.

In January 1999, the District of Columbia Circuit Court of Appeals struck down the “significant scientific agreement” standard as “ unconstitutionally vague.” More specifically, the court ruled that the FDA is required to permit a health claim if the quality of scientific evidence supporting the claim is at least equal to the quality of the scientific evidence against the claim. In July 2003, the FDA finalized its regulations for considering qualified health claims and began accepting petitions in September 2003.