The world is facing a global epidemic of diet-related chronic diseases, with one in every five deaths caused by a diet lacking in essential nutrition. Eating a diet rich in nutrients is necessary for our overall health and provides us with energy for activity and growth. Nutritious foods provide valuable health benefits that can reduce the risks of illness. Nutritionally enhanced foods can further improve health, while remaining distinct from pharmacological drugs due to their nutritive value and their sole use in a dietary role. In this blog, we will discuss how we can make simple dietary adjustments which can serve our food as medicine.
What are functional foods?
In recent years, the term ‘functional food’ has gained popularity in health and wellness circles. When we talk about functional food, we mean highly nutritious food with several powerful health benefits. Functional foods provide additional macronutrients, vitamins, and minerals. These foods may also contain active compounds, ingredients, phytonutrients, enzymes, and live cultures that help to lower the risk of harmful diseases.
What are medical foods?
Medical foods are specialised foods made to meet the nutritional needs of patients with specific medical conditions, it can also be described as food as medicine. Medical foods support patients who are, or are at risk of becoming, malnourished; for example, those unable to receive essential nutrients from typical food due to digestive issues. A product must follow strict regulations and labeling requirements to be considered a medical food. Medical foods, or food as medicine, consist of ingredients recognised as safe. They are processed explicitly, as opposed to occurring naturally. It is important to note that, although medical foods do not require a prescription, they should only be used under medical supervision.
Often, there is confusion in the nutraceuticals industry because of the many regulatory and informal categories used to define products in this market. Regulated categories, for example, include dietary supplements, conventional foods, medical foods, and foods for particular nutritional use. But another categorisation is based on the product’s distribution channels, which may include conventional food stores, natural products, and healthcare practitioners. Other product segmentations include benefit/indication, consumer demographics, and product formats.
The growing interest in cognitive support
In recent years, we’ve seen significant growth in the cognitive support market, mirroring a rise in age-specific health concerns. For example, baby boomers now reaching their golden years wish to preserve their brain health as they age. Intense competition in schools has motivated young people to improve their focus and concentration. And significant numbers among our modern, fast-paced workforces are attempting to manage stress, improve performance, and prevent burnout.
Clinical nutrition and medical food product growth
Clinical nutrition products represent a sizable and growing market. Global sales of medical foods are projected to reach between $20 billion and $30 billion. It’s estimated that the US represents 50% of this market. The EU follows,with around 25% of remaining sales, while the rest of the world, mainly Asia and South America, makes up the final 25%.
These figures highlight important questions and critical strategic decisions:
- Do ingredients and formulations conform to local regulatory requirements?
- Can ingredients and recipes be harmonised to the strictest regulatory standards to ensure compliance by design?
- What are the best sales channels? Does the cost of goods (COGs) match expected sales?
Adhering to multiple regulatory requirements takes a lot of work, especially given the fine distinctions that exist between the terms nutraceuticals, functional foods, dietary supplements, and food as medicine. One of the most important differences between these products is that US regulatory agencies do not need pre-market approval for marketing or claims. However, the EU and UK require a pre-approval process for health claims and product marketing associated with the products. For this reason, the development of clinical nutrition products for global markets faces regulatory hurdles. Focusing on countries with more clearly defined requirements may be the solution.
Product benefits and regulation
A product benefit is a positive value that customers are intended to experience through the use of a given product. Product benefits can vary, but will generally satisfy at least one of a customer’s needs, expectations, requirements, or motivations for using that product. Once a product’s intended benefits are established, developers can create a roadmap to commercialisation. This involves gathering the information needed to satisfy regulatory requirements. It is necessary to assess the safety, mechanism of action, and efficacy of nutraceuticals with clinical data. Some of the data can be used to support sales activities by helping to frame the product’s claims and better informing consumers, healthcare professionals, and the industry itself. If a claimed health benefit is not properly backed up by safety information or in-vitro and in-vivo data, this can have serious repercussions for a product’s viability.
To achieve the stringent requirements of most territories, a product must demonstrate:
- Appropriate target identification
- A safety assessment
- A clear understanding of the mechanism of action
- An efficacy assessment substantiated by clinical studies
- An evaluation of possible interactions with other products (food, food supplements, and drugs)
Medicinal products are well-defined. They must follow exacting legislation on efficacy, safety, production, and therapeutic use to be authorised and marketed. The dose and mechanism of action must be identified in detail, as must possible undesired side effects and pharmacokinetics depending on the amount and the method of administration. Each step must be fully addressed before a new drug can be considered for the market. Once a medicinal product is placed on the market, its benefit-to-risk ratio continues to be assessed throughout its entire lifespan.
Requirements for the advertisement of product benefits
Any product benefit claims made through advertising must not be misleading or false, and must be substantiated when they’re made. Generally, expectations for the substantiation of food as medicine will include corroborating results from at least two double-blind human trials.
When manufacturers want to substantiate claims for their labeling, the key aspects to consider are:
- 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
The Food Trade Commission (FTC) and the FDA allow manufacturers to design and conduct clinical tests to substantiate product claims.The FTC and FDA do not stipulate the exact quality and quantity of evidence, but the evidence must match the claim’s nature and specificity
Develop new products and expand your portfolio with inewtrition
At inewtrition, we’re here to help you develop new product ideas or expand your portfolio to meet customer demands for healthier, functional, sustainable foods. Our industry experts can help you find new opportunities to grow your business in the sectors of medical food, preventative health, and functional food science. With more than 25 years of experience in the food industry, we are experts at fast-tracking innovation without compromising on quality.
If you’re interested in working with our talented team, contact us or book a free intro call today.