(The Claims-Research Connection)

A FIM Proposal

July 1996



A system in which exclusivity for product claims can be reasonably obtained will dramatically increase nutraceutical research leading to major medical advances within the next decade.

A nutraceutical is a food or parts of foods that provide medical-health benefits, including the prevention and/or treatment of disease Such products may range from isolated nutrients, dietary supplements and diets to genetically engineered “designer” foods, functional foods, herbal products and processed foods such as cereals, soups and beverages. FIM coined the term nutraceutical in order to give a clear-cut identity to this broad product category so that Congress can consider it as a distinct entity in any attempt to formulate legislation that will encourage nutraceutical research. The importance of the “identity issue” is clearly substantiated by the highly successful Orphan Drug Act. The entity “Orphan Disease” was, not too long ago, defined. Congress then passed the Orphan Drug Act based on the established definition of an Orphan Disease. The proponents of DSHEA adopted this approach by defining a dietary supplement. Congress then enacted DSHEA based upon this definition. DSHEA’s definition of a dietary supplement is almost identical to FlM’s definition of a nutraceutical.

The purpose of the conference was to help FIM draft this legislative concept document which contains the principles of a proposed new Congressional Act that will dramatically increase nutraceutical research by establishing an academic-industrial research complex similar to that which presently exists in the pharmaceutical and biotech industries.

FIM has long maintained that increased nutraceutical research would lead to enormous and immediate benefits such as:

1. Increased discovery regarding clinical efficacy.

2. Increased discovery regarding clinical safety.

3. Reliable information for both physicians and consumers (patients and nonpatients) based upon such research.

4. Improved quality of life and decreased health care costs.



The Nutraceutical Revolution began with the calcium, fiber and fish oil phenomenon when clinical data were published supporting the benefit of these natural substances. The clinical-expert-physicians communicated to medical and consumer media regarding the positive clinical data, and the media then communicated these claims to practicing physicians and consumers. What resulted, and has continued, is a clinical-expert-physician-media driven market involving a few products. A research-oriented nutraceutical industry that would deliver many products that will have a major impact on disease remains nascent. The era of the traditional nutritional gurus’ dominant influence has begun to decline. As a result of this phenomenon, the nutraceutical market is now and will continue to be a physician-consumer targeted one.

The clinical data-expert-physician-media interface continues to create a powerful national appreciation of – and hunger for – information on nutraceuticals that extends beyond the interest of traditional health food store visitors. The regulatory groundrules regarding health and medical claims, however, have prohibited companies from educating the public regarding the positive results of these studies. As a reaction to such restrictions, public pressure arose and led Congress to pass two new laws the NLEA and DSHEA – which primarily deal with expanding the rights of companies to make health claims. It is highly probable that there will be further legislative efforts by the turn of the century, attempting to bring nutraceuticals into the mainstream of health care in order to increase the quality of life of both the healthy and the sick, as well as substantially reduce health care costs.

For well over a decade, FIM has maintained that reasonable, unambiguous groundrules regarding nutraceutical health and medical benefit claims, substantiated by clinical research, are needed to spark nutraceutical research. Moreover, over and above these groundrules, any new system must provide opportunity for a proprietary or exclusive product position. This self-evident belief is supported by the traditional pharmaceutical and biotechnology industries, where product proprietary positions are sufficiently strong to justify substantial investments in research and development. In 1991 FIM published a White Paper recommending the Orphan Drug model as one that would be appropriate for nutraceuticals. The White Paper advocated a system in which a company that sponsors research would have the exclusive right to make a claim regarding the results of such research for a seven-year period. It also recommended that applications for such claims be reviewed by expert committees on a case-by-case basis and not by any standing regulatory or governmental body.

Returning to NLEA and DSHEA, FlM’s position has been that the groundrules for claims are not sufficiently industry-friendly to create large investments in nutraceutical research. The NLEA and DSHEA deal principally with the right of consumers to have existing information made available to them and not with the need to increase research to assess the validity of such information. In response to the right to have such information, FIM has consistently maintained that valid information requires sufficient scientific and clinical research to provide it. The good news is that during the very recent past, FIM has managed to convince opinion leaders in industry, government and consumer groups to appreciate and publicly support the importance of nutraceutical research. This support is an essential element in any effort to convince the Congress to pass appropriate nutraceutical legislation.



Medical and scientific experts agree that the nutraceutical promise is enormous – more so than is generally appreciated. Natural substances have multiple beneficial effects that can profoundly ameliorate or rid us of much that ails us. For example, there is substantial evidence that carnitine has beneficial effects on myocardial ischemia, congestive heart failure, cardiac arrhythmias, and adriamycin-induced cardiac toxicity. Folic acid is efficacious for the management of anemia, the prevention of neural tube defects, the reduction of homocysteine levels (a cardiovascular risk factor) and the reduction of drug toxicity. Garlic and soy both have broad and exciting spectra of clinical promise. The nutraceutical list is long and excitingly promising.

The good news is that basic nutraceutical research continues to produce impressive and promising data. The bad news is that our system profoundly discourages the clinical research necessary to test even a small percentage of these substances. This is so because of the absence of a research-intensive nutraceutical industry which has the economic resources and incentives to sponsor clinical research. To compound the problem, there has been a significant decrease in our national clinical research capacity because of changes in the health care system that emphasize short-term costs coupled with an alarming decrease in the number of qualified clinical investigators.

Additional good news, however, is that many nutraceuticals already exist and are presently distributed, only waiting to be clinically evaluated. If our system would substantially encourage clinical research, then much of this promise would be evaluated and delivered to us in the very near future. To compound the problem for those who need new remedies, there appears to be a pharmaceutical and biotech drug lag where the product pipelines do not promise major medical breakthroughs within the very near future. Even if promising drug products are discovered in the laboratory, the average time for them to be approved and made available to consumers by a physician’s prescription is well over a decade.



There are two ways by which the government can create a system that establishes sufficient product exclusivity to create a research-intensive, academic-industrial complex: One is a large effort and the other a small one.

The large effort: This approach is based on new legislation allowing an established, legal body to grant exclusivity for a product claim to a person or organization that conducts the research. The successful Orphan Drug Act is a good example of this type of system. In this case, the FDA is the body that reviews the data, grants the seven-year exclusivity claiming period and has the authority to accept or reject an Orphan Drug NDA. The FDA has performed admirably in this system. The vast number of potential nutraceutical products and the lack of voluminous NDA-types of data, however, that will almost invariably be generated to support efficacy and safety of nutraceutical products, would make it difficult for the FDA to be the official arbiter of nutraceutical applications for exclusivity. FDA presently lacks both the manpower and cultural mentality to take on this role. Recognizing this in its White Paper, FIM recommended the establishment of expert committees as an additional semi-independent arm of the FDA to both officially review and grant exclusivity for a product claim on a case-by-case basis.

This would be an enormous undertaking both in effort and costs. Congress, in the absence of powerful advocates and its concern with cost reduction, is very unlikely to take up this cause at this point in time.

The small effort: This involves a small modification of DSHEA regarding claims which would lead to the industry itself creating exclusive nutraceutical products rather than a governmental body granting them via official approval of claims. DSHEA states that companies can make claims regarding structure-function, well-being, classic deficiency and mechanism of action but prohibits companies from making medical claims regarding beneficial effects on disease. A good example of this contradictory and confusing language is the case of Ocean Spray Cranberry Juice. This product has been shown to decrease the recurrence of urinary tract infections in a study published in JAMA. According to DSHEA, Ocean Spray cannot claim the truth, i.e., that its product “prevents urinary tract infections.” instead, a claim that it “promotes a healthy urinary tract” may be acceptable. In this system, the more research the company does to demonstrate the clinical or medical benefit of its products, the less it can say about them! Succinctly put, DSHEA discourages truthful claims and encourages confusing or half-truth claims!

A claiming structure which permitted companies to tell the truth about their products would lead to an intensive research-oriented nutraceutical industry. The companies themselves would create, research and develop proprietary or exclusive products utilizing unique formulations or other approaches and market such products. For example, a company would create a patented, concentrated, low calorie, once-a-day cranberry juice, perform clinical trials to demonstrate its efficacy and launch the product as a low-car cranberry juice nutraceutical that decreases recurrent urinary tract infections while increasing patient compliance (easier to take).

The conclusion is that simply eliminating DSHEA’s prohibition of claims regarding disease is the FIM answer. “How to do it in a way that is practical?” is the question. What amount of evidence is needed, and how can this evidence be judged to be sufficient to make the claim? These are the two legitimate questions to be resolved.

Some specific FIM recommendations are as follows:

1. Expand DSHEA to permit medical claims to be made to physicians only, and let DSHEA stand as is for consumer claims.

2. Establish a mechanism for peer review of the data by a group of experts that is not binding but must be made available to physicians. What comes to mind is the mechanism to handle off-label educational efforts in the drug industry. The FDA has lived with the system for a while and is more or less comfortable with it. There are other feasible or practical options which can be pluralistic rather than confined to a single mechanism.

3. Broaden DSHEA’s definition of dietary supplement to include foods in general. This is essential in order to tap the enormous economic resources of the food industry for nutraceutical research and development. Though presently the food industry is not research intensive, it must and will eventually become so because of the powerful nutraceutical market forces. It needs an environment, however, in which it can culturally and more rapidly change.

4. Establish clear medical principles regarding nutraceuticals where physicians can, for example, live with less rigorous data than the FDA requires for a New Drug Application. Physicians should, for example, be very comfortable with certain mixtures without the need to know the hypothetical, single, magic bullet in a particular mixture that may not exist or, if it does exist, may not be as efficacious as the mixture itself. Cranberry juice and lots of vegetables and fruits are current examples of the legitimacy of such an approach. This “nutraceutical medical philosophy” is essential to make opinion leader elements of our society comfortable with the aforementioned recommendations. FIM is considering convening a group of experts to formulate such a medical philosophy.



Presentations were made at FlM’s Sixth Nutraceutical Conference (“THE NEED FOR A RESEARCHINTENSIVE NUTRACEUTICAL INDUSTRY: WHAT CAN CONGRESS DO? (The Claims – Research Connection)”, May 9, 1996) by three experts in the food, OTC and herbal industries. Robert Donovan and Lyn Ciocca presented the results of the informal surveys they had conducted of executives in the OTC and herbal industries, respectively. Dr. Enrique Guardia presented his opinion as well as those of his colleagues in the food industry gleaned from personal experience. The opinions of the speakers and those interviewed do not represent official industry positions regarding nutraceutical research. No such position, in fact, has yet been formulated or presented to Congress. The core conclusions of the three presentations are:

1. Nutraceuticals represent a new important health sector.

2. Research is necessary to deliver the benefits of nutraceuticals.

3. Clear and reasonable groundrules for making health or medical claims would encourage industry to perform the research necessary to demonstrate the benefit and safety of nutraceuticals.

4. It is essential that the system provide a means to obtain exclusivity for health and medical claims for a period of time.

(In the past, FIM has contacted many corporate executives regarding a minimum period of exclusivity that would encourage them to fund research. A minimum three-year exclusivity period seems acceptable to virtually all those interviewed.)

After these presentations, the panelists and members of the audience discussed the findings and recommendations of the three presenters and enlarged upon the discussion with individual observations and recommendations.

The following is the Executive Summary of FlM’s conclusions of the conference formulated with the aid of the panelists:



1. Purpose of the Conference: FIM convened the conference to determine ways in which the Congress can help establish a nutraceutical research- intensive industry.

2. Many believe that the delivery of the promise of nutraceuticals that will beneft the American public, both in the prevention and treatment of disease, requires Congressional attention.

3. In the recent past, Congress, in an effort to educate the public regarding the health benefits of nutraceuticals, enacted NLEA and DSHEA. These acts are primarily geared to education via promotion, and not structured to substantially increase nutraceutical research.

4. After discussion at the meeting, FIM concluded that the following three factors would significantly stimulate a research-intensive industry:

a. A system to obtain claims that is not too lengthy or costly.

b. A system in which both health and disease claims can be made, based on peer-reviewed, preclinical and clinical data.

c. Most importantly, a system that provides for proprietary or exclusive claims.

5. After analyzing the discussions regarding #4, FIM concluded that four major new provisions should be enacted. They are:

a. Dietary supplements and conventional foods must have the same opportunities and standards for bearing claims.

b. In addition, all companies should have the right both to make statements of nutritional support on consumer product labeling based on scientifc (preclinical) and clinical data, and to provide to licensed health care professionals any other scientific or clinical data that relates the product to the prevention, management, or treatment of disease or other health-related conditions.


c. Given reasonably independent, respected peer review of the quality of the clinical data, companies should have the right to provide the information to the public as well as licensed health care professionals.

d. In order to stimulate research, the sponsor of the research shall have the exclusive right to convey the information for commercial purposes for a limited period of time.

The consistent and persuasive theme of the need for a reasonable system to obtain exclusivity for a claim as being essential to stimulate corporate research strongly supports FlM’s long-held position. What was surprising, however, was the very strong support for the proposition that companies should be permitted to make both health and medical claims, including those related to the prevention and treatment of disease, directly to the public. This issue demands serious consideration as a major policy issue in our national health care system.

Considering the enormous importance and urgency of establishing a reasonable system that permits claim exclusivity, FIM plans to convene a body of individuals with appropriate know-how and wisdom to formulate such a system. Finally, the comments, positions and recommendations made in the conference report are officially those of FIM.

Stephen L. DeFelice, M.D.


FlM’s Sixth Nutraceutical Conference held on May 9, 1996 at The Hyatt Regency Washington on Capitol Hill, Washington, DC “THE NEED FOR A RESEARCH-INTENSIVE NUTRACEUTICAL INDUSTRY: WHAT CAN CONGRESS DO? (The Claims-Research Connection)



Lyn Ciocca, Consultant

Stephen L. DeFelice, M.D., Chairman, The Foundation for Innovation in Medicine

Robert G. Donovan, Consultant, and former Chairman of NDMA (Nonprescription Drug Manufacturers Association)

Enrique J. Guardia, Ph.D., Consultant and former Group Vice President, Technology, Kraft General Foods

Senator Tom Harkin (D-IA), Senate Labor and Human Resources Committee; Ranking Member-Senate Subcommittee on Disability Policy; Senate Agriculture, Nutrition and Forestry Committee; Ranking Member-Subcommittee on Research, Nutrition and General Legislation; Senate Appropriations Committee; Ranking Member-Labor, HHS, Education Subcommittee; Senate Small Business Committee



David Collins, Consultant and former Chairman of NDMA

Stephen L. DeFelice, M.D.

Robert G. Donovan

Peter Goldman, M.D., Professor of Health Science, Department of Nutrition, Harvard School of Public Health

Enrique J. Guardia, Ph.D.

Louis Lasagna, M.D., Dean, Sackler School of Graduate Biomedical Sciences, Tufts University

Stephen H. McNamara, Esq., Hyman, Phelps & McNamara, P.C. (former Associate Chief Counsel for Food, FDA)

Robert E. Smith, Ph.D., Senior Vice President, Research, Nabisco, Inc. and President-Elect of the Institute of Food Technologists

Jur Strobos, M.D., of Counsel, Greenberg, Traurig, P.C. (former Director, Policy Research, Office of the Commissioner, FDA)



Senator Bill Frist, M.D., (R-TN)

Patricia Knight, Health Policy Advisor to Senator Orrin Hatch

Paul A. Lachance, Ph.D., Professor & Chairman, Rutgers University, Food Science Department