Nutraceuticals, Nutrition Supplements: Challenges

Nutraceutical is a combination of two words “nutrient” and “pharmaceutical.” Nutraceuticals and nutritional supplements are collectively referred to as “dietary supplements,” intended to be taken orally. The discovery, development and marketing of nutraceuticals and related products are currently the fastest growing segments. This trend is driven by several factors, mainly due to the current consumer perceptions: the first and dominant being 'Natural is good', and other secondary, such as the increasing cost of many pharmaceuticals and their negative secondary effects, the insistent marketing campaign, the increasing perception of the need of a healthy diet and its importance in the health and homeostasis organism conditions. The use of supplements is suggested to (but may not claim to) diagnose, cure, mitigate, treat, or prevent diseases. Often, background information suggests that they are intended to affect the structure or function of the body. However, they do not undergo premarket approval. The common reasons for using dietary supplements are to improve conditions such as overall health and disease prevention, performance, and appearance. These are often perceived as safe and less likely to have side effects. The scientific research on nutraceuticals and nutrition supplements is frequently misinterpreted or overstretched for commercial interests because of high consumer demands. The manufacturing and marketing of supplements are full of challenges.

The below picture represents three main categories of nutraceuticals , which can be further categorized as traditional and non-traditional nutraceuticals. Traditional nutraceuticals are food in which no change is made, simply natural, with known potential health qualities. Several fruits, vegetables, grains, soy, tea, and chocolate apart from fish, dairy, and meat products have been noted to contain health-benefiting properties. Non-traditional nutraceuticals are the outcome of agricultural breeding or added nutrients and/or ingredients. Examples are orange juice with calcium and cereals added with vitamins or other nutrients. The viewpoint behind nutraceuticals is focused on prevention, inspired by the saying “Let food be your medicine, and medicine be your food”. In other terms, nutraceuticals are what we eat or a specific component of food, providing health benefits as a preventive or a curative agent naturally. Many of these products in the market find their origin from the plant kingdom. Nutritional supplements also contain substances alone or in combination with vitamins and minerals, with or without other herbal products, with or without zoochemical (creatinine, glucosamine, melatonin, bee pollens) and with or without probiotics.

Challenges:

Several challenges associated with the development of nutraceuticals are often ignored because of a lack of authoritative control. These challenges include identification of the authentic source of raw materials, purity of the compound, presence of other active compounds, quality, lack of experimental evidence, false advertising, contamination with heavy metals, and interactions between supplements and drugs. For example, a common herb “ginseng” has several varieties such as California ginseng, wild ginseng, prickly ginseng, Pacific ginseng, Malaysian ginseng, Indian ginseng, Peruvian ginseng, Southern ginseng, Brazilian ginseng, and wild-red ginseng. All of these are sold as ginseng, but none of these belongs to the genus Panax, which contains real ginseng including Korean ginseng (P. ginseng), South China ginseng (P. notoginseng) and American ginseng (P. quinquefolius). The supplements that are not prepared under strict GMP conditions may have unintentional contamination, including microbes (pathogens/nonpathogens), pesticides, mycotoxin (aflatoxin), heavy metals etc.

There is a controversy over a specific definition and set of regulations to define the nutraceutical compounds. The definition of nutraceuticals may not be well established worldwide. The global spread of nutraceutical products has dramatically increased recently. The main factor that lead to inflating the market share of these products, is that nutraceuticals have no strict regulations to control them. On the other hand, pharmaceutical products are controlled by strict regulations and are closely monitored. Moreover, nutraceuticals have been advertised under the claim of being safe, effective and being a drug substitute. Additionally, it has been claimed that these products can be used in preventing and treating many health problems without any side effects. Therefore, the market share of nutraceuticals has been tremendously expanded. 

Besides, maintaining the quality of nutraceuticals is another challenge, as phytochemistry is inherently variable due to seasonal and geographical variations. It is challenging to measure and maintain consistency in finished products and limit undesirable constituents. Interaction of herbal supplements with medicinal drugs is also a big concern. Among all the major concerns for using the nutraceuticals is the lack of scientific evidence. Some are never tested under properly controlled experimental conditions, and unlike pharmaceuticals, most nutraceuticals do not undergo “randomized controlled clinical studies.” 

The extensive usage of these products should be supervised closely and regulated. Some countries developed new regulatory bodies for monitoring these products. In the USA, nutraceuticals are regulated as “drugs, food ingredients and dietary supplements” due to the lack of a definite definition. In contrast, in Europe, the European Food Safety Authority (EFSA) acknowledged the nutraceuticals terminology and outlined regulations to ensure their safety. Moreover, the Dietary Supplement Health and Education Act (DSHEA) and Drug Administration Modernization Act are responsible for confirming the safety of nutraceuticals before commercializing them. According to FDA, the label of any nutraceuticals or dietary supplement products should state that “This statement has not been evaluated by the FDA. This product is not intended to prevent, cure, or treat any disease” 

Nutraceuticals formulations are hampered by many obstacles that negatively affect their efficacy. Many natural active ingredients suffer from low solubility, poor permeability, fast metabolism, short half-life and others. For instance, curcumin has low solubility, poor oral bioavailability, limited tissue distribution, short half-life, and rapid metabolism. Additionally, Epigallocatechin Gallate (EGCG) is a bioactive compound in green tea that has a vasculo-protective effect through its antioxidative and hypolipidemic effects. However, EGCG uses are limited because of its fast degradation in the gut and low solubility. These kinds of challenges that jeopardize the nutraceuticals existence push scientists and formulators to use different novel systems to maximize nutraceuticals safety and efficacy.

Current and Future Status:

The current status of nutraceuticals in the global market is alarming. The chaotic scene starts with the terminology and categorization, where these products are not considered medications. No uniform, consistent or standardized regulations govern the manufacturing, sales or marketing of such products. All these products are sold with major therapeutic claims as natural safer substitutes to medications. 

Finally, it is concluded that the term “nutraceutical” is poorly defined across the globe and from a regulatory perspective not clearly classified either as a category of food or pharmaceuticals. Subsequently, it is a challenging task for the regulatory authorities in the different parts of the world. However, clear and common regulations for nutraceuticals will be urgently needed in the near future to cope with rapidly emerging trends and demands in the global market. 

Conclusion:

This article describes the challenges and attempts to provide a navigation compass to the pharmaceutical/nutraceutical scientist through this complex maze. The realization that dietary supplements are beneficial for both proactive and reactive health issues has opened doors and eyes to the benefits of what the industry produces. Customers want products to have strong science and clinical data to support any claims. They want products that are easy, convenient, and enjoyable to take. Overall goal of this article is to present readers with high-quality scientific evidence for the use of dietary supplements, nutraceuticals, and functional foods that can be appropriately used to improve health parameters in various stages of one’s lifecycle. High quality standards in the dietary supplement industry are important to retaining consumers and appealing to new users.

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Funding:

This research article did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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About the Author:

Dr. Ajay Kumar Singh, M.Sc. (Gold Medalist), Ph.D. is the author and founder of “Pharma Solutions by Dr. Ajay”.

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Examples used in this article are not meant to be endorsements of any product or technology from the author.