FIM proposes nutraceutical principles, applies them to medical foods

Nutraceuticals International, February 1997, Vol 2, No 2

Part 1

The Foundation for Innovation in Medicine (FIM) held a two-day conference in New York City, USA, in late November, exploring the topic How to Develop, Make Claims on and Market Medical Foods. In keeping with the FIM’s definition of nutraceuticals as including foods that fall into the Food and Drug Administration’s medical foods category, FIM chairman and conference organizer Stephen DeFelice focused on the central role of research, and effective communication of research results, in the successful marketing of all nutraceuticals, including medical foods.

Announcing that “FIM is the eyes and ears of the nutraceutical industry,” Dr. DeFelice opened the meeting with his personal observations as to why the nutraceutical revolution is irreversible: * the $250-billion potential US nutraceutical market, in his estimation, is more than three times the size of the current US $80-billion pharmaceutical market; * potential players in this market include a wide range of business types, including not only food, pharmaceutical, and over-the-counter companies, but biotech and nutritional technology start-ups, different types of marketing companies and consulting businesses, approaching customers at many levels, from the individual consumer to the healthcare practitioner to the wholesale supplier, retail distributor, managed health care provider, and multilevel marketing organization, to the institutional (hospital) market; * the cost to enter the nutraceutical is about one-fortieth of that to enter the pharmaceutical market; * bringing a nutraceutical to market takes one-fifth the time it takes to bring a drug to market; and * the profit margins of nutraceuticals are comparable to those of pharmaceuticals.

Some people in the industry may (and did) challenge these estimates. Thomas Aarts, publisher of Nutrition Business Journal, for example, estimates the US nutraceutical market at $80 billion, which is about the size of the current US pharmaceutical market. Even the challenges, however, supported the tone of the FIM’s message, and illustrated the attraction of the emerging nutraceutical market.

Dr DeFelice concluded his opening comments with predictions about the future of the nutraceutical industry, and the wide-ranging impact he expects to accompany the full emergence of this product category. Stemming from his personal vision of where the industry is heading. Dr DeFelice’s prognostications represent a possible resolution of issues raised at this (and other) intensive discussions of nutraceuticals. He expects to see new definitions of health and sickness, definition of “functional foods,” “herbs,” and other hazy regulatory or marketing categories, a new concept of the distinction between prevention and treatment of illness, and a growing acceptance of the primacy of dietary supplementation over the value of a “nutritious” or “well-balanced” diet. He predicts the emergence of new type of company that has the research orientation and regulatory savvy of pharmaceutical companies and the marketing and formulation skills of food companies.

Medical foods represent a problematic opportunity for the nutraceutical industry. The definition of this regulatory category was codified in the 1988 amendment to the US Orphan Drug Act of 1983, not in the 1984 Dietary Supplement Health and Education Act (DSHEA), which is often regarded as having opened the gate to the US nutraceutical industry. Whereas DSHEA specifies that dietary supplements are for the maintenance of health (structure/function), and not for the treatment or management of disease, medical foods are “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation,” and they are to be used under medical supervision.

Food products labeled as being intended for use, under medical supervision, in the dietary management of a recognized “disease or condition,” qualify as medical foods and, like dietary supplements, do not need FDA premarket clearance. But successful marketing of dietary supplements and medical foods does depend on the availability and communication of scientific evidence for product efficacy. Invoking the disintegrating boundaries between prevention and treatment, (medical) food and medicine, Dr DeFelice called for a single set of principles defining “sufficient evidence” supporting both medical (disease prevention) and health (maintenance) claims. His proposal follows.

The FIM’s Nutraceutical Principles for Sufficient Evidence for Medical-Health Claims: 1. There must be sufficient clinical data to reasonably support the claim. (They need not be double-blind.) 2. Reasonable surrogate markers instead of clinical endpoints can be sufficient to support a claim. 3. Acceptable preclinical data to support the product rationale is desirable but not always necessary. 4. All pertinent data must be published in respectable medical-scientific journals. (First step of the peer review process.) 5. Independent, consensus or expert group opinion should be obtained. (Second step of the peer review process.) 6. Post-marketing surveillance. This effort should concentrate particularly on the aspect of safety.

More on this meeting in the January 1997 issue of NI.


LaChance backs use of term ” nutraceuticals “

Paul LaChance, chairman of the Rutgers University food science department, has forecast that “nutraceuticals” will outlast “functional foods” and “designer foods” as product descriptors. Writing in Food and Chemical News recently, Dr LaChance defined nutraceuticals as “any food or ingredient that provides medical or health benefits, including disease prevention.”

He outlines three layers of defense against nutrition related diseases: * Iifestyle prevention (diet and exercise); * metabolic prevention; * end high tech-rescue medicine “as a last resort.” He argues that “metabolic prevention” is where nutraceuticals do their work. He has defined a “desirable blood index” of vitamin C, vitamin E and carotene that individuals should try to attain, noting that in vitro studies show vitamin C as the first line of defense against free radicals caused by oxidation, with beta carotene as the last line of defense.

Dr LaChance also suggests that there should be an “antioxidant index” consisting of both nutrient and non-nutrient antioxidants in the diet.

Noting that the nutraceutical industry now accounts for $17 billion sales worldwide, he says he envisages a three-tier dietary strategy against nutrition-related diseases, made up of the USAD’s Food Guide Pyramid, fortified foods and dietary supplements. Asked about the US Food and Drug Administration’s long-standing resistance to therapeutic claims for food products, he argues that Sanford Miller, the former Bureau of Foods director, has “tunnel vision.”


FIM conference revisited: questions, controversy and criticism

Part 2

The December 1996 issue of NI summarized the key discussion points raised by Foundation for Innovation in Medicine (FIM) founder and chairman, Stephen DeFelice, at FIM’s November 20 and 21 conference on medical foods, in New York City, USA. In light of the definitional questions coming under the scrutiny of the US Food and Drug Administration (NI vol 2, no 1), it should come as no surprise that FIM’s conference stirred up lively discussion among the participants, and between speakers and the audience.

At the heart of most of the controversies stood fundamental questions of definition. Although “medical foods” comprise a category of products regulated by the FDA, the statutes do not clarify ambiguities in the FDA treatment of “food,” which cannot be labeled with product-specific health or medical claims, or the intrinsically therapeutic nature of medical foods and labeling. The FDA has voiced its intention to regulate medical foods not as foods or drugs, nor as dietary supplements, but has only recently started re-evaluating these statutes.

FIM’s definition of “nutraceutical” – a food or part of a food that has a specific health benefit, including the prevention or treatment of disease – is so broad that it covers not only dietary supplements and functional foods, for which the FDA permits certain statements of nutritional support, but also medical foods, which have a well-recognized and critical role in providing the nutritional requirements of people who are receiving medical supervision for an acute or chronic condition that imposes specialized nutritional needs. FIM’s conceptualization of medical foods as a subset of nutraceuticals informed and shaped the conference, and prompted much of the commentary.

Louis Lasagna of Tufts University raised caveats about the real-world significance of regulations. People are using the products now, regardless of the regulatory structure. It is pointless to distinguish between food and drug, because “significant scientific agreement” on the therapeutic value of any food or drug is meaningless, she said.


Need to distinguish therapy and treatment of disease

Donald Louria of Rutgers University urged that it is important to distinguish therapy and treatment of disease from health promotion/disease prevention, and pointed out that most nutritional epidemiology claims do not hold up. He warned the audience of the crucial importance of understanding the complex interactions between different nutrients. Dr Louria expressed his deep concern about a trend he has noticed; recent nutracoutical/functional food developments seem to be more consumer-driven than health- or research-driven. He does predict, however, that full decipherment of the human genome will generate a rich source of information that will, in turn, stimulate the science-based development of food and nutritional products.


Difficulties in understanding specific actions of nutrients and foods noted

Richard Rivlin of Memorial Sloan-Kettering Cancer Center emphasized that the links between food, nutrition and health are too important not to be a collaborative focus of government, industry and academia Pointing out, “we don’t eat nutrients, we eat foods,” he emphasized the inherent difficulties in understanding the specific actions of any one element (nutrient) in a multicomponent system (food). Dr Rivlin recommended that the research community overcome these problems by careful selection and appropriate use of biomarkers. He also suggested that postmarketing surveillance should cover not only safety but also efficacy of medical foods and other nutraceuticals.

Two of the most provocative comments followed Fredric Price’s case study of Applied Microbiology’s development and marketing of Cardia salt alternative, which is being introduced as a medical food for medically-supervised, medication-controlled hypertensives who have been unable to reduce their salt intake (see also page 10). Dr Rivlin commented: “your product is not a no-salt product, it’s a low-salt product. From this it follows, will some patients therefore not reduce their salt and might even get more salt than they would ordinarily … or at least an equal amount, by taking more of a low-salt alternative just as many people now consume more calories by reducing their fat?

Responded to the question, Mr Price said: “we are marketing to those people who can’t give up salt…. your argument would suggest that SmithKline Beecham and McNeil should not have launched over-thecounter nicotine patches because the best thing is to just stop smoking. Well, we know that’s the best thing to do. But if you can’t just stop smoking, those two products, and others like it, are terrific ways to gradually reduce the amount of nicotine. It’s a huge market…if we get several million patients on Cardia and, over time, some of those patients drift away from Cardia, having reduced their sodium by half [in] the absence of Cardia or anything else, that’s not a problem. The market is big enough for me that I don’t mind losing some of these people, because I’ll get the new people coming in at the same time.”

Judith Eaton of the New York Nutrition Network introduced the nutritionist’s perspective on the question, saying: “…this [Cardia] has a place, and I can see that, but what you’re doing with this [direct] education of pharmacists and physicians [is] bypass[ing] the nutritionist. Its going to be used like … Sweet ‘n Low and aspartame… It’s gotten out of hand… you need to refer these patients to a nutritionist… Until you recognize that this is how we’re going to lower health care costs, health care is going to stay the same …we’re just providing other pharmaceuticals and we’re giving people pills.”

The tenor and complexity of the comments reflect the complications that are emerging as the nutraceutical market matures.