Staking a claim for a functional food or beverage can set a product apart in the marketplace. Current trends in new product development and sales of functional foods and beverages show that industry is ready to supply the consumer with condition-specific products.1,2 Preparation for a successful claim requires planning, not only from a marketing perspective, but from a scientific and regulatory perspective as well.

The Nutrition Labeling and Education Act of 1990 (NLEA) amended the Food Drug and Cosmetic Act (FD&C) to allow for claims for foods and dietary supplements, provided certain conditions were met. One type of claim allowed--the nutrient content claim--characterizes the level of a nutrient in a food, including dietary supplements. The NLEA also allowed for other claims for foods, food ingredients and dietary supplement ingredients, as discussed below.

With the new demand for “functional foods,” the lines between dietary supplements and foods have become blurred. FDA has not formally defined the terms “functional food” or “neutraceutical,” although use of the terms is commonplace. Health claims, qualified health claims and structure-function claims are permitted for food and dietary supplement ingredients. Both health and qualified health claims allow for labeling that indicates that the ingredient reduces the risk of a particular disease and requires pre-market approval of the claim wording by FDA. In addition, structure-function claims also allow labeling that indicates that the ingredient affects the structure of function of the body; however, these claims do not undergo a pre-approval process.

Health Claims
Health claims (HC) are considered by many in industry to be the gold standard of claims. With strong language describing the benefits of risk reduction of disease, it is easy to understand why. An example of an HC3 is the Calcium and Osteoporosis4 claim that is permitted for use with conventional foods and dietary supplements. According to FDA, this claim can be stated on labeling as: “Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.” Another example of an HC is the Sodium and Hypertension5 claim, which, in contrast to the Calcium and Osteoporosis claim, is only permitted on conventional foods. The Sodium and Hypertension claim can be stated on labeling as such: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.” Both of these claims are cited in the Code of Federal Regulations (CFR), as the FD&C Act requires that regulations be promulgated for all approved health claims. 

HCs are approved in one of two ways: 1) petition the FDA to issue a regulation authorizing a health claim or 2) obtain a published “authoritative statement.”  The authoritative statement may be obtained from a scientific body of the U.S. government with official responsibility for public health protection, or research directly relating to human nutrition about the relationship between a nutrient and a disease or disease prevention-related condition. These authoritative bodies include, but are not limited to, the National Institutes of Health, the Centers for Disease Control and Prevention and the National Academy of Sciences. 6

Regardless of which path is taken, the FDA will review the health claim using the Significant Scientific Agreement (SSA) standard. This standard, derived from 21 U.S.C. 343 (r)(3)(B)(i), provides that FDA shall authorize a health claim to be used on conventional foods, if the agency "determines based on the totality of the publicly available evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence." 7  Following review of the claim and substantiation data, FDA has the authority to deny, prohibit or modify the HC. Only claims that meet the SAA or the “first level” of scientific ranking are allowed to make an unqualified HC.  Those claims for which the data does not substantiate the claim to the SSA level must “qualify” the claim, so consumers are not misled about the nature of the supporting science.

Qualified Health Claims
In contrast to HCs, qualified health claims (QHCs) 8 have scientific backing characterizing a relationship between a substance to a disease or health-related condition, but not to the level of significant scientific agreement. These claims have much weaker language and require “qualification” based on an evidenced-based scientific ranking of the substantive data for the claim (see chart “Standardized Qualifying Language for qualified health claims”) 9.

Examples of QHCs include two current QHCs related to “green tea and cancer” that are permitted for conventional foods and dietary supplements containing green tea. The claims permitted are as follows:
1. Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.
2. One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.

Consumer testing has shown that claims such as these are not clearly understood, or they have a negative impact on consumers’ perceptions of the product, 10 understandably leading industry to refuse embracing this approach to claims. Consumer confusion is a key concern and is the driver for change. In a recent Government Accountability Office (GAO) report, 11 one recommendation for FDA was to work with other federal agencies and stakeholders to evaluate a simplified, empirically valid system that clearly conveys the overall nutritional quality of the food to the consumer. Many stakeholders prefer a uniform rating system using symbols on the front of the package to help consumers choose healthy foods over the existing HC and QHC system. This type of rating system is not a novel idea in the U.S. or abroad. The heart-check symbol is a recognized symbol in the U.S. for a “heart-healthy” food, and the familiar traffic light symbol is in voluntary use in the U.K., with green indicating the healthiest choice and red as the least healthy choice.

Structure-function Claims
Structure-function claims (SFC) focus on statements that relate to the role of a nutrient or dietary supplement ingredient and the affect on the structure of function of the body, providing that the claims are not disease claims. Traditionally, the SFCs on conventional foods have been associated with nutritive value, while dietary supplement SFCs focused on nutritive and non-nutritive effects. 12

SFCs are not as confusing as the QHC, are well-received by the consumer, 10 and, therefore, popular with industry. Entire product lines of conventional food products now tout the healthy benefits of added ingredients by using SFCs. These ingredients must be either Generally Recognized as Safe (GRAS) or approved under a Food Additive Petition (FAP) in order to be added to conventional foods. Examples of SFCs range from orange juices with added glucosamine and plant sterols added for joint health, and cholesterol and yogurts for gut health.

An additional benefit of SFCs is that time to market is reduced, as these claims are not subjected to the health claim authorization standard. The FDA does not review the data supporting the SFC for either a food or dietary supplement ingredient and does not require conventional food manufacturers to notify FDA of a SFC or require disclaimers. In contrast, notification to FDA is necessary for SFC for dietary supplements, along with a disclaimer that FDA has not evaluated the claim and that the supplement is not intended to “diagnose, treat, cure or prevent any disease.”

Prior to marketing food or dietary supplement products with SFCs, the manufacturer must have substantiation for the claim, even though this information is not subject to pre-market review by FDA. The data to adequately substantiate a SFC, while nebulous, clearly is less than that required for support of an HC or a QHC. FDA stated, in the final rule for Regulations on Statements made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 13 that it understands some SFCs “that are acceptable under DSHEA may be difficult to substantiate,” and “few dietary supplements have been the subjects of adequately designed clinical trials.”

Claims Substantiation
Following the determination of the possible range of claims available, the process of “staking a claim” can begin. All claims require substantiation, but what is an adequate level of substantiation? The HC is required to meet the SSA standard, while the QHC is rated, measured and classified based on the evidence available. The SFC is required to be truthful and not misleading and to have substantiation. Obviously, adequate substantiation differs for the different claims, and in some cases, substantiation is not clearly defined (as for the SFC).

The requirements of adequate substantiation for an HC are outlined in FDA’s Guidance to Industry7 and clearly states that adequate substantiation to support a health claim requires “that the totality of the publicly available evidence supports the substance/disease relationship that is the subject of the claim,” and “that there is significant scientific agreement among qualified experts that the relationship is valid.” Further, the guidance and past FDA decisions on petitions confirm that adequate substantiation must include human clinical data supporting the claim, with the gold standard being randomized, double-blind, placebo-controlled interventional studies. 7, 14

While publication of studies conducted for SFC are not required, the publicity generated from a supporting study that has been peer reviewed and made publicly available is desirable. Publicly available, substantial clinical investigations are required to support an HC or a QHC, seemingly in direct conflict with Section 912 of the recently passed FDA Additives Amendment Act (FDAAA) of 2007, which prohibits addition of any approved drug or a drug for which “substantial clinical investigations” have been instituted and made public.

Under Section 912, if a company conducts a clinical trial for substantiation of an HC, a QHC or SFC and publishes the supporting results, does this thrust the ingredient into the drug status category--therefore making the ingredient ineligible for addition to food? FDA has recently called for comments on questions such as this for review, prior to issuing an interpretation of Section 912. 15 Even with the likely outcome being that FDA will use “enforcement discretion” on a case-by-case basis, during the course of the comment period and decision making, developing products utilizing SFC will not come to a halt. Staking a claim is still possible, but more planning and foresight is now required to walk the fine line between not enough and costly overkill. As always, the first step in planning the clinical data portion of the claims processes is to ensure that the ingredient does not have, or ever has had, a New Drug Application issued or been tested in a publicly available clinical trial study as a drug. This may deem the ingredient as a drug and prevent use in food or supplements. If an NDA or drug trial has not been conducted on the candidate ingredient, the next step in substantiation is to develop a protocol to test the appropriate end-points for either a health or structure-function claim. Poor protocol development may result in the need for costly clinical trials to be repeated. Therefore, help in planning by a professional is well worth the cost. Next would be the evaluation and composition of a dossier in support of the claim and decision to publish or not to publish the data. The type of claim pursued would have a direct impact on the decision to publish the data. If an HC or a QHC is sought, publication or public availability is required.

Key to staking a successful claim, whether the claim is in the form of a statement or symbol, is proper planning and execution involving product development, marketing, science and regulation. Substantiation of any claim is required; however, with the recent questions posed by Section 912, careful consideration must be given to the strategy employed for substantiation.  NS


1 Sloan, AE. 2008. Food Technology. 62:55-60.
2 Ohr, L M. 2008. Food Technology. 62:97-103.
3 FDA Health Claims: Site visited October 2008.
4 Title 21 of the Federal Code of Regulations §101.72.
5 Title 21 of the Federal Code of Regulations §101.74.
6 FD&C Act §403(r)(3)(C).
7 Guidance for Industry Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements: Site visited October 2008.
8 CFSAN website: Site visited October 2008.
9 FDA, 2003. Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data ( Site visited October 2008.
10 IFIC. Qualified Health Claims Consumer Research Project Executive Summary. International Food Information Council (IFIC) 2008.
11 GAO, 2008. FDA needs to better leverage resources, improve oversight, and effectively use available data to help consumers select health foods. Report no. GAO-08-597.
12 FDA, 2004. Structure Function Claims ( Site visited October 2008.
13 Federal Register, 2000. Volume 65, Number 4, pp. 999-1050.
14 FDA, 2006. Qualified Health Claims: Letter of Denial-Green Tea and Reduced Risk of Cardiovascular Disease (Docket No. 2005Q-0297).
15 Federal Register, 2008. Volume 73, Number 146, pp. 43937-43940.