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U.S. Legislation: Light at the end of the tunnel?

In cases in which scientific evidence has been overwhelmingly established for a particular food or ingredient's relationship to a particular disease condition, to the point where "significant scientific agreement" has been attained, as defined by the Food and Drug Administration (FDA), a health claim can be obtained. For example, the FDA has recently authorised a health claim for foods containing sterol or stanol esters and the reduced risk of heart disease based upon their clinically established ability to lower serum cholesterol.

A health claim may also be obtained by utilising a published authoritative statement from an appropriate scientific body of the United States Government with official responsibility for public health practitioner research directly relating to human nutrition. For example, Pepsico's Tropicana Products Inc. was successful in obtaining a health claim recognising the relationship between intake of potassium and high blood pressure and risk of stroke. Their declaration was based upon authoritative statements from the National Academy of Sciences. Upon its authorisation by the FDA on October 31, 2000, Tropicana immediately initiated a marketing and advertising campaign. Competitors were not prepared and could not capitalise upon this newly authorised health claim as rapidly. This resulted in a limited but unsustainable marketing advantage.

Without an approved health claim, a structure/function claim, which is defined as a statement that "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans", or a statement that "characterises the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function", can be used. However, information regarding the proper usage other than recommended daily dose, potential side effects, and conditions of use must be withheld due to labelling laws.

Due to very restrictive health claim authorisation, most products are marketed with structure/function claims. These claims are vague and often confusing to consumers. They cannot offer marketers any means to differentiate their products from others on the market. For instance, an orange juice containing vitamins C and E makes the claim "Supports a healthy immune system". The same claim is made by other beverages and dietary supplements containing echinacea.

The current system discourages investments in research into the health benefits of functional foods and nutraceuticals as one company may invest resources in clinical research and regulatory expertise to obtain a specific health claim. Subsequently after approval all companies can use the same claim provided the quantities of active ingredient are specified. Under the current system a patented process to isolate or manufacture the ingredient or a short time window for marketing promotions upon approval of an FDA health claim should be used.

There is agreement within the regulatory establishment, academic communities, consumer advocates and food industry, among others, that claims need to be truthful, not misleading and substantiated by clinical evidence. Consumers need to know that the products they are buying on the basis of a claim for health benefit will deliver more than hope. If consumers understand the potential for foods and dietary supplements to manage their health and potentially reduce their risk of diseases, a significant portion would regularly purchase these products.

A solution has been proposed by the Research-based Dietary Ingredients Association (RDIA), which was created in 1998 to develop and promote base-line scientific standards to ensure that functional food and dietary ingredients are safe and effective for consumers. The RDIA is proposing to create incentives for conducting clinical research in functional foods and nutraceuticals. This proposal includes two parts: (1) an independent third-party review system to evaluate the scientific substantiation supporting a particular structure/function claim, and (2) a distinguishing label mark or type of claim for products that have undergone this independent review. The first provides scientific validation that a particular claim is substantiated and appropriate, while the second communicates this information to the consumers and enables the manufacturer to utilise this information for marketing advantage. The end result will be a return on the investment required to complete the clinical evidence supporting the benefit.

The third-party review system is modelled after the Generally Recognised As Safe (GRAS), a system that has been very successful. The proposed GRAE (Generally Recognised as Efficacious) would focus on the intended statement of benefits instead of the safety of consumption. A company would convene an independent panel of experts qualified in the field to evaluate the intended claim and supporting evidence. This expert panel would determine whether the potential statement of intended benefit was appropriate or not. Advice for additional studies could be one outcome from this panel, which may complete the dossier needed to establish the ingredient or food as GRAE. At the conclusion, this panel would write and publish a summary of their findings.

In November 2001, RDIA and The Life Science Research Office (LSRO), an office of the American Society for Nutritional Sciences, a constituent society of FASEB, held a stakeholders conference, to discuss the potential of establishing a third-party review system. This standing room-only meeting produced very active debate by representatives from government, industry, trade associations, consumer advocates and academia. After extensive discussion, a favourable consensus was reached regarding this review system. Consequently, LSRO is setting up such a system to conduct these independent reviews. LSRO has conducted numerous independent reviews of safety and efficacy for many governmental agencies, associations and companies. The second piece of the RDIA proposal is a distinguishing label mark or type of claim for products that have undergone this independent review. A marketing payback completes the incentive for conducting the clinical studies and undergoing independent scrutiny. Such an incentive for research is lacking within the current system.

Companies are hesitant to invest in the product clinical trials without a way to recover the investment in the market. If research does not support increased sales or brand awareness of their product, and cannot be protected by some other means, companies have no incentive to invest in it.

The RDIA is proposing the creation of an approval mark or certifying credential that consumers could use to distinguish between products that had undergone this independent review process. This mark can be compared to the FOSHU logo in Japan, which identifies products, which have been approved by the government as Foods for Specified Health Use. Such a certifying mark or logo can be a successful mechanism to communicate with consumers.

An additional option may be to legislatively create a category of claims that are exclusive to companies successfully undergoing a GRAE declaration. In other words, structure/function claims are relatively generic, and are very limited in their communicated messages. A nutraceutical claim may be created whereby additional information is allowed and could explain the intended benefit and conditions of use. However, there is great risk in initiating a legislative solution as many groups are publicly and vehemently critical of the Dietary Supplement Health & Education Act of 1994 and would significantly change it if they could.

All of these approaches are possible, but would require new legislation in the United States. Legislative change requires consensus and active support by industry. One concern, voiced by smaller companies, is a fear that large companies with greater resources could corner categories of claims. This argument is countered by those who say that all companies, regardless of size, need to provide scientific evidence for their products and label claims. Clearly, a solution will need to balance different interests while providing an environment that promotes investment.

Consumers want to take a greater role in maintaining their health through the use of foods and dietary supplements. More information is needed to understand the boundaries of these potential health benefits and interactions between dietary ingredients and other factors. Government researchers may eventually conduct this research, but it will be much more effective to create incentives for companies interested in selling such products to conduct the research to support those products.

—Rhonda S. Witwer
GalaGen. Inc.
Tel: +1-952 258 5508
Fax: +1-952 258 5608
Web site:

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