Proposed health claims by Weider not based on "authoritative statements" -- FDA.

ANTIOXIDANT/SUPPLEMENT HEALTH CLAIMS BASED ON USDA, NIH, CDC STATEMENTS BARRED because the statements are not "authoritative" as defined by the FDA Modernization Act, FDA says in nine interim final rules published in the June 22 Federal Register. The rules respond to notifications by Weider Nutrition International that it planned to use health claims for several vitamin and supplement products under the recently enacted FDAMA procedures providing for use of health claims without FDA preclearance if they are based on "authoritative statements" by government scientific bodies.

Weider's notification was the first to be submitted under FDAMA, and FDA decided to make its response to the submission public and open to comment to help define the agency's approach to implementing the provision. Under FDAMA, the agency can deny use of the claims if they do not meet the requirements of the law. Weider said it will discuss the matter with FDA and may file additional claims in the future.

For the most part, FDA agreed the organizations that issued the statements are appropriate government scientific bodies as envisioned by FDAMA. However, the agency also concluded the statements provided by Weider were not the product of a deliberative review of the scientific evidence or were preliminary or inconclusive.

As a result, FDA concludes "the notification does not include any authoritative statement published by a scientific body as required by...the act," and the claims are not "authorized." In two cases, calcium and vitamin K, the agency concluded the FDAMA provision did not apply to the claims themselves.

Among Weider's prospective claims is that vitamins C, E, A and beta-carotene "may reduce the risk in adults of atherosclerosis, coronary heart disease" and "certain cancers." For vitamins C and E, the claim also would include a reference to a reduction in the risk of cataracts. For B-complex vitamins, the company proposed the claim, "B-complex vitamins -- folic acid, vitamin B6, vitamin B12 -- may reduce the risk in adults of cardiovascular disease by lowering the elevated serum homocysteine levels, one of the many factors implicated in the disease."

The proposed chromium health claim is: "In adults, chromium may reduce the risk of hyperglycemia and the effects of glucose intolerance." For omega-3 fatty acids, Weider proposed: "In adults, omega-3 fatty acids may reduce the risk of cardiovascular disease." Other claims included: "In adults, garlic may reduce serum cholesterol and the risk of cardiovascular disease" and "In adults, zinc may increase the body's ability to fight infection and heal wounds."

Weider submitted more proposed "authoritative statements" to support its claims for the antioxidants than any of the other vitamins or supplements. Eleven statements were filed in support of the claims for vitamin A and beta carotene and six statements for vitamins C and E.

Many of the statements submitted were taken from publications of the U.S. Department of Agriculture and its Agricultural Research Service. Some statements came from the National Institute on Aging and the National Cancer Institute and others from the Centers for Disease Control & Prevention and the U.S. Surgeon General. A report developed by the Federation of American Societies for Experimental Biology Life Sciences Research Office at the request of HHS and USDA also is cited.

For example, one statement, extracted from the 1995 "Nutrition and Your Health: Dietary Guidelines for Americans" public information brochure issued by HHS and USDA, is: "The antioxidant nutrients found in plant foods (e.g., vitamin C, carotenoids, vitamin E and certain minerals) are presently of great interest to scientists and the public because of their potentially beneficial role in reducing the risk of cancer and certain other chronic diseases." FDA notes "the statement points to the need for future research and suggests that whether a relationship exists should be the subject of scientific study, but does not indicate that there exists a scientifically sound relationship that should be accorded a presumption of validity."

Another statement taken from an NIA 1994 information piece available on the Internet is: "[Antioxidants] may help prevent disease. Antioxidants fight harmful molecules called oxygen free radicals, which are created by the body as cells go about their normal business of producing energy....Some studies show that antioxidants may help prevent heart disease, some cancers, cataracts and other health problems that are more common as people get older."

FDA notes the information piece is intended to inform readers about chemicals being studied that may play a role in aging and what scientists have learned about them so far. When asked whether the information is an "authoritative statement" under FDAMA, the National Institutes of Health "responded to FDA that the statement is not...because it was prepared by an individual from the National Institute on Aging and is not based on a deliberative review of the scientific evidence regarding the nutrient-disease relationship."

Many of the statements were derived from research summaries issued by USDA through its quarterly Human Nutrition reports or other sources. One statement, "When people don't have enough of these [B12 and folate] vitamins to metabolize homocysteine, it accumulates in the blood and damages the vessels," is taken from a description of studies conducted at the USDA Human Nutrition Research Center on Aging. However, USDA told the agency the quarterly reports "describe progress on individual projects without a deliberative review of all the relevant scientific evidence."

A single statement was submitted by Weider in support of a cholesterol reducing claim for garlic. The statement, "Garlic is well-known for its medicinal benefits: lowering blood cholesterol, fighting off infections and boosting the immune system," was taken from a 1995 USDA press release summarizing the development of the first garlic seeds. USDA explained to FDA that information pieces such as press releases also "describe progress on an individual project without a deliberative review of all relevant scientific evidence."