Often times there is confusion in the nutraceuticals industry due to multiple regulatory and colloquial categories and segments commonly used to define the products in this market. For example, regulated categories include dietary supplements, conventional foods (e.g., with health claims), medical foods, and foods for special dietary use (FSDU) (e.g., weight management, infant formula).

Another categorization is based on product distribution. Distribution channels may include conventional food stores, natural product stores, healthcare practitioners, multi-level marketing, catalogue, and e-commerce. Other product segmentations include benefit/indication (e.g., glycemic control, sports nutrition), consumer demographics (e.g., millennials, boomers) and at times, product forms. A shortcoming of many segmentation models is that they fail to focus on the consumer or patient, and their unmet needs.

Healthcare Institutions
An intriguing and emerging distribution channel for dietary supplements is found in healthcare institutions. This differs from the healthcare practitioner channel in that institutional distribution targets hospitals, sub-acute care centers, nursing homes, and medical home care. Each of these large and growing markets address specific patient needs or requirements—be they disease management or preventive in nature. An additional aspect of distribution in these settings is that institutional usage often drives future retail sales. Also, being prescribed or recommended by a healthcare professional has been shown to improve patient compliance and product usage.

Supplements and other nutritionals used in healthcare institutions can cross multiple regulatory categories, including medical foods, dietary supplements (e.g., multivitamins/minerals), conventional foods (e.g., fortified snacks), and foods for special dietary use. During our earlier careers in hospital nutrition, we collectively referred to these products as “clinical nutritionals.”

Is there an advantage to assessing opportunities for products as clinical nutritionals? Might the positioning enhance third-party (insurance) coverage? Will it allow for clearer communication of the benefits or applications of products? Does it help healthcare practitioners better understand which products may be appropriate for their patients? In this month’s Business Insights column, we look at clinical nutritionals in hope of identifying opportunities.

Defining Market Categories
The FDA generally regards dietary supplements as being for healthy populations, while medical foods are reserved for sick people (disease management). But we also know that regardless of FDA definitions, many patients with disease or injury use—and their physicians/practitioners recommend—dietary supplements to help manage their disease or condition. There may be benefits of the clinical nutrition categorization regardless of where the products are used.

In 1988, the FDA defined medical foods as: “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is 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.”

Companies such as Abbott Nutrition and Nestle Health Science called this category of products “medical nutrition.” The term defined products designed for medical conditions like pulmonary disease, diabetes, and malnutrition risk in ill or elderly people. This category experienced significant growth in the late 1980s through the 1990s when dietitians and other healthcare professionals recommended products such as Pulmocare, Glucerna, and Ensure, (Abbott Nutrition); and Nutren Pulmonary, Boost Glucose Control, and Nutren 1.0 (Nestle Health Sciences).

Even Carnation Instant Breakfast (CIB), introduced in 1964, (previously called Breakfast Essentials) became a player. Initially, CIB marketing targeted people who wanted breakfast on the go. Savvy patients and healthcare professionals soon realized that it was a convenient, palatable, and far less expensive way to add nutrients and calories to the diet, in that CIB was nutritionally comparable to basic medical nutrition products. CIB quickly became serious competition for medical nutrition, further muddying the waters for true
medical nutritionals.

Today, some of these medical nutrition products are simply referred to as meal replacement shakes, because the FDA said they are not medical foods since they are often indicated for conditions that can be managed with therapeutically-modified diets consisting of regular foods.

The FDA defines dietary supplements as products that: “... are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases ... However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.”

Clarifying A Category
Because of the blurred category lines between foods and supplements in multiple regulatory categories, we offer the viewpoint and potential opportunities of positioning medical products as clinical nutritionals.

This categorization is useful because clinical nutrition products are backed by an extensive scientific dossier. The dossier document provides the scientific rationale for product formulation. It details the scientific findings that support claims. Ideally, it describes the intended population and benefits they can expect from product use. It may also describe expert opinion (derived from a review of the literature) to show “significant scientific agreement” (SSA) about benefits and claims.

While regulatory bodies do not now require an SSA document for medical foods or dietary supplements, they can and have asked for extensive evidence to support claims and answer other questions about product efficacy and safety. We believe this type of document is necessary for clinical nutritionals. It also serves a valuable purpose in marketing products to healthcare practitioners and other institutional influencers and decision makers.

The clinical nutrition view provides a language for discussing a category that already informally exists in the marketplace. From a regulatory standpoint, it helps to clarify claims that can be made, evidence that is required, and other regulations that must be met. This approach could open new doors for nutraceutical products in healthcare institutions and expand use in other distribution channels.

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Gregory Stephens
Windrose Partners

Greg Stephens, RD, is president of Windrose Partners, a company serving clients in the the dietary supplement, functional food and natural product industries. Formerly vice president of strategic consulting with The Natural Marketing Institute (NMI) and Vice President of Sales and Marketing for Nurture, Inc (OatVantage), he has 25 years of specialized expertise in the nutritional and pharmaceutical industries. His prior experience includes a progressive series of senior management positions with Abbott Nutrition (Ross Products Division of Abbott Laboratories), including development of global nutrition strategies for disease-specific growth platforms and business development for Abbott’s medical foods portfolio. He can be reached at 267-432-2696; E-mail: gregstephens@windrosepartners.com.

Sheila Campbell, PhD, RD
Sheila Campbell, PhD, RD, has practiced in the field of clinical nutrition for more than 30 years, including 17 years with Ross Products Division of Abbott Laboratories. She has authored more than 70 publications on scientific, clinical and medical topics and has presented 60 domestic and international lectures on health-related topics. She can be reached at smcampbellphdrd@gmail.com.