Product ClaimsThe action of nutrients used as ingredients in products can be attributed to their nutritive value. Nutritive value is often considered as a regulatory basis for adding such ingredients to food products (i.e. for technical effect). As opposed to any pharmacological effect, foods are typically used for other purposes. Dietary supplements, foods for special dietary use, and medical foods are typically not used for their taste and aroma but can be used for their nutritive value. Nutritive value often serves as the basis for distinguishing the use of a product as a food or dietary supplement versus its use as a drug. Nutraceuticals are bioactive or chemical compounds acclaimed for their valuable biological activities and health-promoting effects. The definition for “functional food” describes “food products fortified with special constituents that possess advantageous physiological effects”. Whereas “the approved health claim; recommended daily intake of the food; nutrition information; guidance on healthy eating; a warning against excessive intake, if necessary; any other special precautions relating to intake, preparation or storage, and other information”. Foods for Special Medical Purposes (FSMPs) are intended for the dietary management of diseases in patients with an impaired digestive function such as absorption. Making them the most medically-oriented food category. An example would be symbiotic and postbiotics where the conversion of nutrients by the microbiota changes molecules into factors that may be more bioavailable. And/or more bioactive and can have a beneficial effect. We appreciate that many health benefits associated with dietary fiber intake are due to microbial fermentation of prebiotics fibers in our guts. Consuming prebiotics like resistant starch that were historically found in human diets but severely depleted in modern diets leads to important health benefits.
Defining medical foodsIn the US, the FDA defined medical foods in 1988 as: “a food which is formulated to be consumed or administrated 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”. The FDA has issued a series of “Frequently Asked Questions (FAQs) About Medical Foods”. These documents emphasized that medical foods do not require regulatory pre-approval but remain subject to the FDA oversight. To be considered a medical food, a product must comply with FDA regulations and labeling requirements, be comprised of ingredients that are Generally Recognized As Safe (GRAS), and be specifically formulated and processed (as opposed to naturally occurring). Importantly, although medical foods do not require a prescription, they should be used under medical supervision. Sometimes there is confusion in the nutraceuticals industry due to multiple regulatory and colloquial categories commonly used to define these products. 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 formats (capsules, chews, tablets).
Growing MarketClinical nutrition products represent a sizable and growing market. Global sales of what we refer to as medical foods in the US are projected between $20 and $30 billion. Geographically, we estimate the US to be 50% of the market. The EU follows with approximately 25% of sales with the “rest-of-the-world” at 25% (predominantly Asia and South America)1. With that, a number of strategic decisions should be made upfront to navigate around the complex regulatory framework associating with this category. Are there one or more countries that are more suitable than others? Which product category will be the best fit for the product? Do ingredients and formulation conform to regulatory requirements for that category? Can ingredients and recipes be harmonized to the strictest regulatory standards to ensure “compliance by design”? Which is the best sales channel? Does cost of goods (COGs) match the expected sales in that channel? Technical evidence of safety includes the
- chemical identity of the substance
- the method of manufacture
- analytical data on composition and specifications
- estimates of dietary exposure and
- safety data from animal and human studies.
Regulatory Requirements and Product ClaimsThere has been a lot of confusion between the term “nutraceuticals” and others such as “functional foods”, “dietary supplements” or “medical foods”. And adhering to multiple regulatory requirements can be increasingly difficult. One of the most important differences between these products globally is that US regulatory agencies do not require premarket approval for marketing or claims. While the EU and UK have a pre-approval process for health claims and product marketing associated with the medical food equivalent Food for Special Medical Purposes (FSMP). Developing clinical nutrition products for global markets certainly introduces additional regulatory hurdles; however focusing efforts on countries with more clearly defined requirements can help simplify the process. Product benefits inform consumers about the purpose of the product, provide rationale for purchase and, after initial use, hopefully a reason to believe in repeat purchase. Product benefits are articulated in the forms of claims, which can be viewed at the nexus between product use, science, regulatory requirements, and consumer choice. Once product claims are developed based on health benefit, product developers can find clear pathways to product commercialization. This involves assembling information needed to satisfy regulatory requirements. Some of the information (e.g. regarding claims) can be used to support sales activities, optimize and maximize the commercial opportunity.
Clinical DataNot to state the obvious, it is wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. It is important to understand and frame the meaning of the claim to the consumer, healthcare professionals and the industry itself. Often the claimed health benefit may not be properly substantiated by safety and efficacy information or in-vitro and in-vivo data which can induce false expectations and miss the ultimate objective. This exercise may require:
- Appropriate target identification
- Safety assessment
- A clear understanding of the mechanism of action
- Efficacy assessment substantiated by clinical studies
- An evaluation of possible interactions with other products (food, food supplements and drugs)
Starting PointAs a starting point, a different approach for nutraceutical concept evaluation, use and definition is often needed. And the existing assessment methodology for pharmaceutical products may be considered and leveraged. Medicinal products are well-defined for specific indications. They must follow specific legislation on efficacy, safety, production and use in therapy to be authorized and marketed. The dose and mechanism of action must be identified in detail, as must possible undesired side effects and pharmacokinetics depending on the dose and on the method of administration. Each step is clearly designed and addressed before a new drug can be considered for the market. Once a medicinal product is placed on the market, its benefit/risk ratio continues to be assessed throughout its entire lifespan. It should be noted that the necessary time to develop a new nutraceutical is reduced compared to the time required to develop a new drug. Considering the natural origin of the constituents of a nutraceutical. And that a nutraceutical is formed by many natural substances and not by a single substance, as in a drug.
Advertising ClaimsAdvertising claims must not be false or misleading. And must be substantiated at the time they are made. Advertisers are required to have a reasonable basis for concluding that advertising claims are accurate. And that representations of claims made in advertising have a particular level of substantiation. Generally, substantiation expectations for medical foods would be the “gold standard” of two multicenter, double blind human trials. Key aspects to consider when manufacturers want to substantiate claims made in labelling:
- the meaning of the claim(s) being made
- the relationship of the evidence to the claim
- the quality of the evidence
- the totality of the evidence