CRN RECOMMENDS CONGRESSIONAL OVERSIGHT OF FDA's FOLIC ACID HEALTH CLAIM

CRN RECOMMENDS CONGRESSIONAL OVERSIGHT OF FDA's FOLIC ACID HEALTH CLAIM and the agency "s process in developing the claim. Speaking at a Feb. 18 "town meeting" convened by Rep. Elton Gallegly (R-Calif.) in Ventura, Calif., Council for Responsible Nutrition President J.B. Cordaro suggested that Congress "examine the clumsy, plodding and time-consuming process whereby FDA finally arrived at a folic acid claim which was focused on conventional food."

Cordaro asserted that the folic acid claim for dietary supplements is "unworkable and threatening." FDA finalized a dietary supplement health claim for folic acid and the prevention of neural tube defects at the beginning of January ("The Tan Sheet" Jan. 3, p. 7).

In his prepared testimony, Cordaro suggested to Gallegly that Congress "ask FDA how it can justify" approving a health claim for fruits and vegetables as sources for antioxidant vitamins, but not allow a health claim for supplements containing "the same vitamins." FDA formally disallowed dietary supplement health claims for antioxidants and cancer in another final rule published in early January. However, FDA said it is awaiting the publication of a major study on the health benefits of antioxidant vitamins and "stands ready" to support antioxidant health claims that are supported by "significant scientific agreement."

In addition to CRN, NNFA and CSPI, Gallegly invited FDA Special Assistant for Policy Mitchell Zeller to testify at the hearing, as well as Elliot Balbcrt, president of the dietary supplement firm Natrol. Other attendees included Joan Priestly of Citizens for Health and American Preventive Medical Association President Julian Whitaker, who was part of a coalition that recently petitioned for an emergency stay of FDA's final rule on health claims ("The Tan Sheet" Feb. 14, p. 18).

The CRN president also questioned FDA's position opposing the distribution to consumers of study reprints.

In addition, Cordaro charged that FDA "ignored the advice" of expert panels from the Federation of American Societies for Experimental Biology that a health claim for omega-3 fatty acids and heart disease be approved. Cordaro also reiterated support for pending dietary supplement legislation that was introduced by Reps. Gallegly and Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) in April 1993.

To expedite the process of approving health claims, National Nutritional Foods Association Science & Technology Director Burton Kallman, PhD, recommended to Gallegly that a "rational system of data evaluation...be developed to determine the degree of strength of the data behind a claim."

Kallman suggested that "grades...be established to inform the public of the extent of the science which supports a claim." Such an approach, he maintained, will require an objective reviewing organization that could be comprised of representatives from government, academia and industry.

Center for Science in the Public Interest Senior Staff Attorney John Gleason acknowledged that dietary supplement legislation introduced by Gallegly, Richardson and Hatch "contains some improvements over existing law." He noted that the bills would ensure compliance with good manufacturing practices, establish a government office to deal directly with dietary supplements and create a specific regulatory framework for supplements rather than the current "cumbersome" practice of regulating nutritional products as either foods, food additives or drugs.

Despite those improvements, Gleason noted that CSPI is "concerned" that the bills "would provide consumers with less protection from unsafe and misleadingly labeled dietary supplements than is afforded under current law." Two problems that CSPI has with the bills, Gleason said, is that they would place the burden on FDA to prove that a supplement product is unsafe, and they would allow health claims based on "preliminary, unreliable scientific evidence" as opposed to "significant scientific agreement" stipulated by the Nutrition Labeling & Education Act. Gleason said he was also testifying on behalf of the American Cancer Society, Consumers Union, the American Heart Association and the American Association of Retired Persons.

Gallegly said his goal is to "ensure continued access to dietary supplements" and that he is working to "pass legislation as soon as possible."

Noting that the "bottom line is that Congress must enact legislation within the next few months," Gallegly pronounced: "I will do anything I can to make that happen." Gallegly's field hearing, which was rescheduled from January due to the earthquake in Southern California, follows Capitol Hill hearings on the Richardson/Hatch/Gallegly bills held by the Senate Labor & Human Resources Committee and the House Energy & Commerce health subcommittee in the summer and autumn of 1993.