CSPI International
Center for Science in the Public Interest

Diet & Health/Food Labelling & AdvertisingFunctional FoodsFood Safety StandardsIACFOCodex Alimentarius CommissionWorld Trade OrganizationNAFTAGeneration ExcessSafe Food International

October 9, 1997

Dr. Edward Scarbrough
Manager, U.S. Codex Office
United States Department of Agriculture
Food Safety and Inspection Service
Washington, D.C. 20250-3700

Re: Codex Committee on Food Labeling, U.S. Position on Agenda Items for May 25-28 Meeting

The Center for Science in the Public Interest (CSPI) submits these comments on the draft United States position on health claims, which is an agenda item for discussion at the 26th Session of the Codex Committee on Food Labeling (CCFL) in Canada in May 1998. CSPI believes that the U.S. should oppose a Codex standard for health claims at this time for the following reasons:

(1) It is premature to urge Codex to issue a standard based on the health claims provisions of the Nutrition Labeling and Education Act of 1990 (NLEA) until the U.S. has had more time to reflect upon the success of the Act's health claims provisions. A recent Food and Drug Administration (FDA) study concluded that "[h]ealth claims ... led consumers to believe that the product was likely to have health effects that it did not have." In addition, the study found that consumers may be relying on health claims instead of the more complete and accurate nutrition facts panel in making their purchasing decisions. The study explained that:

"[t]he effect of health claims on label reading behavior was to reduce the likelihood consumers would read the nutrition information on the back of the package, which may explain why health claims appeared to inhibit the acquisition of information from the back of the package. The pattern of findings makes it hard to conclude that the impact of health claims is to produce more accurate perceptions of products' health benefits."
(2) Congress is currently weighing a modification of the health claims provisions of the NLEA. Legislation that has passed the Senate, S. 830, and the House, H.R. 2469, would modify procedures for FDA pre-clearance of claims. Under this legislation, food companies could use scientific statements about nutrition and health made by agencies other than the FDA as a basis for health claims. The FDA is unfamiliar with how the legislation will affect its regulation of health claims and is in no position to advise other countries in this area.

(3) Furthermore, the Dietary Supplement Health and Education Act (DSHEA) of 1994, has blurred the distinction between health claims and structure and function claims. The DSHEA mandates that structure/function claims are not subject to FDA pre-clearance requirements and need not be supported by significant scientific agreement. While manufacturers are required to have substantiation for these claims, neither Congress nor the FDA has defined what constitutes substantiation. Given the thin line that separates structure and function claims from health claims and the confusion that has resulted in the U.S., the FDA should not urge Codex to follow the U.S. example.

For the foregoing reasons, we urge the FDA to oppose a Codex standard for health claims at the present time.

Respectfully submitted,

Bruce Silverglade
Director of Legal Affairs

Ilene Ringel Heller
Senior Staff Attorney