FDA ANNOUNCES INITIATIVE TO PROVIDE
BETTER HEALTH INFORMATION FOR CONSUMERS

Commissioner of Food and Drugs Mark B. McClellan, M.D., today announced a major new initiative to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions.

The Consumer Health Information for Better Nutrition initiative is designed to foster two complementary goals concerning the labeling of food and dietary supplements: to encourage makers of conventional foods and dietary supplements to make accurate, science-based claims about the health benefits of their products, and to help eliminate bogus labeling claims by taking on those dietary supplement marketers who make false or misleading claims.

"By putting credible, science-based information in the hands of consumers, we hope to foster competition based on the real nutritional value of foods rather than on portion size or spurious and unreliable claims," Health and Human Services Secretary Tommy G. Thompson said. "Such labeling can help empower consumers to make smart, healthy choices about the foods that they buy and consume."

The consumer health information initiative comprises three related actions:

• Issuing guidance on qualified health claims for conventional foods and dietary supplements. Any such claims must be pre-approved by FDA and meet the "weight of the scientific evidence" standard, including support by a credible body of scientific evidence.
• Strengthening enforcement of dietary supplement rules. Today, FDA is emphasizing its commitment to carrying out the intent of Congress in the Dietary Supplement Health and Education Act of 1994 by outlining its enforcement strategy against false or misleading claims about dietary supplements. As an example of its commitment to strong enforcement, FDA is also announcing a seizure of a dietary supplement making unapproved drug claims.
• Establishing an FDA Task Force on Consumer Health Information for Better Nutrition. This task force will develop a framework to help consumers obtain accurate, up-to-date, and science-based information about conventional food and dietary supplements. This includes the development of additional scientific guidance on how the "weight of the evidence" standard will be applied, as well as the development of regulations that will give these principles the force and the effect of law.

"Our mission at FDA is to improve health outcomes for the nation, and some of the best opportunities for improving health involve informed choices by consumers," said Dr. McClellan. "Through this Better Health Through Better Information initiative, we are committed to improving opportunities for consumers to get scientifically accurate information about the health consequences of the foods they consume, and to enhancing our enforcement efforts against those who would make false or misleading claims for their products."

The guidance on health claims FDA issued today sets forth the conditions under which the agency intends to exercise enforcement discretion for qualified health claims about conventional foods and dietary supplements. FDA currently permits such claims for dietary supplements under certain circumstances but not for conventional foods - even though in general much more scientific data is available to support the health benefits of foods.

To meet the criteria for making a new, qualified claim on a conventional food, the manufacturer would need to provide a credible body of scientific data supporting the claim. The company would need to demonstrate, based on a fair review by scientific experts of the totality of information available, that the "weight of scientific evidence" supports the proposed claim.

All qualified health claims will require review by FDA before they may be used on the food label.

In the enforcement action being announced today, FDA revealed that United States Marshals on Monday, December 16, 2002, seized approximately 3000 bottles, valued at more than $100,000, of EverCLR, a dietary supplement. EverCLR is marketed by Halo Supply Company of San Diego, Calif., as a "natural" treatment for viruses, including the herpes virus, and for "cold and flu protection."

None of these claims has been substantiated. In court documents, FDA charges that EverCLR is an unapproved and therefore illegal new drug because it is promoted to treat or prevent specific diseases and conditions. FDA also charges that EverCLR is misbranded because its labeling lacks adequate directions for use.

In addition, FDA today released a report on its strengthened enforcement actions over the past year against dietary supplements that make false or misleading claims. FDA's report also outlines an aggressive enforcement strategy against such claims and outlines enforcement priorities so that manufacturers will be on notice.

A Notice of Availability about FDA's guidance on qualified health claims went on display today at the office of the Federal Register. Both the notice and the guidance itself are available online at http://www.fda.gov/ohrms/dockets/default.htm.

FDA's Dietary Supplement Enforcement Report is available on FDA's website, http://www.fda.gov/, as is the document "Consumer Health Information for Better Nutrition," a brief, descriptive summary of FDA's entire consumer health information initiative.

FDA advises consumers to consult a health professional before taking dietary supplements. Information about dietary supplements is available on FDA's website at http://www.cfsan.fda.gov/~dms/supplmnt.html. Consumer advice from FDA about purchasing medicines on-line may be found at http://www.fda.gov/oc/buyonline/default.htm.

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Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements
Federal Register Notice of Availability of Guidance Document -- [1297KB PDF file]
Dietary Supplement Enforcement Report
Dietary Supplement Enforcement Report - Executive Summary
FDA's Consumer Health Information for Better Nutrition Initiative (white paper)
List of Currently Authorized "Qualified" Claims for Dietary Supplements
Complaint for Forfeiture re EverCLR -- [699KB PDF file]

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