Navigating the Maze of Health Claim Regulations

Sept. 4, 2007
FDA's recent guidance focuses only on the process for evaluating evidence supporting a health claim.

FDA recently issued a draft guidance document on the scientific evaluation of health claims on food labels. This is intended to provide guidance to food manufacturers regarding the type of scientific evidence needed to support a proposed health claim.

From a regulatory standpoint, a regulated "health claim" is a claim about the relationship between a substance in the diet and a disease or health-related condition. These claims must be cleared by FDA. They are generally worded along the lines of "a diet rich in substance X may reduce the risk of disease Y."

Traditionally, for a health claim to receive authorization, it must be supported by the "totality of publicly available scientific evidence" and there must be "significant scientific agreement" among qualified experts that the claim is supported by such evidence. This is a fairly high burden to meet, and a small number of health claims have been authorized through this route.

Two innovations have made it easier to get health claims onto food labels. In 2002, FDA issued a guidance document under which a "qualified health claim" may be permitted even though evidence supporting the claim does not meet the "significant scientific agreement" standard -- as long as the claim can be qualified in a way that makes it non-misleading. Qualified health claims are typically worded along the following lines:

Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.

The marketing value of this obviously is doubtful.

One other route exists for making a health claim: A manufacturer may notify FDA it intends to make a health claim based on an authoritative statement from a federal scientific agency, as provided for under the Food and Drug Administration Modernization Act (FDAMA) of 1997. Thus, if the Surgeon General states that substance X helps prevent a disease, this statement can form the basis for a health claim. In the case of an FDAMA-notified health claim, the submitter is not required to show that the significant scientific agreement standard is met.

FDA's recent guidance does nothing to change this basic framework. It focuses on the process for evaluating evidence supporting a health claim, the meaning of the significant scientific agreement standard, and credible scientific evidence needed to support a qualified health claim.

A few highlights from this document include:

  • A defined, measurable substance must be the subject of the claim, such as a food component (fiber), an entire food or a food ingredient.
  • FDA intends to focus primarily on human intervention and observational studies in assessing the scientific support for a health claim. Animal and in vitro studies may be useful, but only in providing background information or explaining a mechanism.
  • Randomized, controlled intervention studies provide the strongest evidence of a relationship between a substance and a disease.
  • Observational studies may suggest a correlation between a substance and a disease, but they generally do not establish a cause and effect relationship.

Not unexpectedly, FDA's guidance document reinforces that a petitioner seeking authorization of a new health claim, other than an FDAMA-notified claim, faces a very significant evidentiary burden. In most cases, food manufacturers will find that the cost of petitioning FDA for an unqualified health claim will outweigh the benefits of making the claim. Furthermore, many manufacturers will find qualified health claims unattractive from a marketing standpoint. This tends to call into question whether food manufacturers will continue to pursue health claims.

At the same time, the food industry must regrettably deal with scientific studies and health messages that are often garbled in the new media. An example is the recent Framingham study on soft dink consumption. This study was widely reported to have shown a link between consumption of soft dinks, both sugar-containing and sugar-free, and an increased risk of metabolic syndrome.

If reports about this study were subjected to FDA's standards, they would have faced numerous obstacles. For example, there was not a defined substance associated with this study (sugar-containing and sugar-free soft drinks being two completely different things), and a single observational study is insufficient to establish a cause and effect relationship. Unfortunately, FDA polices food labels but not newspapers.

David Joy is a partner in the Washington, D.C., office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at

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