News | May 12, 1999

GMA Urges FDA to Reconsider and Revise Health Claims Approval Process

Concurring with the previous statements made by the National Food Processors Association, the Washington, D.C.-based Grocery Manufacturers of America (GMA) is saying the "time is ripe" for the Food and Drug Administration to finally establish mechanisms for the prompt evaluation of health claims for food products submitted to the agency. GMA also called on FDA to "promote the responsible development and use of authoritative statements by federal scientific bodies" that substantiate the health claims brought to the agency. GMA provided these comments in testimony given at a public meeting assessing implementation of the FDA Modernization Act of 1997.

"With consumers increasingly looking to their diets to help improve their health and wellness, the time is ripe for the FDA to provide an efficient, effective, and timely process for dealing with health claims for foods and beverages," said Lisa Katic, RD, GMA director, Scientific and Nutrition Policy.

In formal comments submitted to FDA, GMA urged the agency "to reconsider and revise its entire constricted approach to the use of truthful and non-misleading disease prevention claims in food labeling."

"Congress enacted the authoritative statement provision in the Food and Drug Administration Modernization Act of 1997 as an explicit rejection of the FDA existing regulations governing disease prevention claims," the written comments continued. "Accordingly, the authoritative statement provision should be implemented in an expansive and flexible way."

Katic noted that the First Amendment does not permit FDA to function as a "national censor" on providing useful scientific information to the public.

"The FDA implementation of the disease prevention claims provision cannot withstand scrutiny under the First Amendment to the United States Constitution," said Katic. "GMA's position has subsequently been sustained in Pearson v. Shalala."

In that case, a unanimous panel of the District of Columbia Circuit held that disease prevention claims could not be completely suppressed by FDA. The court required FDA to permit such claims with appropriate disclaimers or other information that would assure that they are truthful and not misleading.

"FDA must construct reasonable ways to communicate diet/disease information that is not yet definitive, with appropriate explanation and disclaimers, in order to better inform the public about this important area of personal health," said Katic.

The complete text of GMA's comments to FDA will be made available on-line at