The term Nutraceuticals is used for chemical compounds derived from food sources with additional health benefits and the basic nutrition profile found in foods. Such products are often considered non­specific organic therapies used to ease symptoms, promote general well­being, and prevent malignant processes that may lead to cancer.

The medical definition of nutraceutical. : a foodstuff (as a fortified food or a dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value. — also called functional food. In the U.S., “nutraceuticals” are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Federal Food, Drug, and Cosmetic Act.

Nutraceutical is derived from two words “nutrient” (part of food that provides nutrition) and “pharmaceutical” (part of food with medicinal and healing properties). The term got its name from Stephen DeFelice in 1989, director of the Foundation for Innovation in Medicine, an American association situated in Cranford, New Jersey.

The principle concept behind nutraceuticals is based on the prevention of diseases, as indicated by the Greek doctor and philosopher Hippocrates, who said, “let food be your medicine.” The role of nutraceuticals in human nutrition is the main area of examination, with a wide range of implications for health­care providers, food producers and distributors, and the end consumer.

Categories of Nutraceuticals/Health Supplements

The nutrition profile and medicinal properties of nutraceuticals rely on the source. They can be categorized based on their characteristic sources, chemical constitution, and pharmacological properties. The following are the major categories of nutraceuticals;

• Medicinal food
• Functional food
• Dietary supplements
• Farmaceuticals

A dietary supplement refers to an item that contains nutrients extracted from food items and packed in the form of a pill, powder, capsule, or liquid. The FDA regulates dietary supplements as foods; however, their regulation varies from other foods and drugs.

As indicated by their definition, functional food is a sub-classification that includes whole fortified or enriched dietary components that may help prevent disease. Functional foods also reduce persistent sickness risk and provide health benefits beyond the conventional supplements it contains.

Farmaceuticals are medically important compounds produced from animals or agricultural yields. The term is a mixture of two words “farm” and “ceuticals.” Defenders of this idea are convinced that utilizing animals and crops as pharmaceutical facilities is more safe and cost-effective than traditional strategies, with higher income for farming producers.

Potential Health Benefits

Nutraceuticals have pulled in significant interest throughout the years because of their potential nutrition value, security, and remedial impacts. They could have a part in plenty of organic cycles, including cell proliferation, antioxidant defenses, safeguarding of mitochondrial integrity, and gene expression. Therefore nutraceuticals are used to postpone the aging process, prevent chronic diseases, support functions and integrity of the body, and improve overall health. Most doctors and nutritionists consider them healthy sources for preventing hazardous illnesses; for example, diabetes, metabolic syndrome, and renal and gastrointestinal issues.

Nutraceuticals have been linked to play a crucial role in improving the immune status and boosting immunity against certain diseases. They also exhibit disease-modifying properties related to free radicals and oxidative stress, including Alzheimer’s disease, Parkinson’s diseases, allergy, eye conditions, cardiovascular diseases, cancer, and obesity.

Nutraceutical /Health Supplement Industry

Nutraceuticals are items derived from animal and plant foods usually sold in medicinal forms. They are characterized as any food component with additional health benefits – including the essential dietary benefit found in food and prevention and disease therapy. Nutraceuticals have gained popularity as an alternative treatment approach to lessen the cost of high­tech treatment options utilized in developed nations.

The nutraceutical industry is an advanced, dynamic, and evolving entity offering novel opportunities and merging scientific discoveries with growing consumer interest in foods. It plays an important role in tracking consumer trends to manufacture the product according to the consumer’s demand. Three main segments are included in the nutraceutical industry – including herbal products, functional foods, and dietary supplements.

Global Demand For Nutraceuticals/Health Supplements

The worldwide nutraceutical industry has gained the greatest development in the most recent decade. Despite the fact that nutraceuticals as an industry arose in the mid-1990s, the world has seen its growth in this century’s first decade. From 1999 to 2002, the industry has seen a yearly growth rate of 7.3 percent.

Today, the worldwide nutraceutical market is estimated to be worth 117 billion USD. In developed markets, customization and personalization are the latest things in improving nutraceuticals. The industry’s current key strategies include investing in research to verify the products’ health claims, find innovative approaches, and market research.

An essential catalyst for such development is customer demand; Buyers are hoping to follow healthy ways of living and acquire ideal nutrition to prevent illnesses, for example, diabetes, allergies and blood pressure. Currently, India, the United States, and the European Union are the world’s biggest nutraceuticals markets; China will probably beat them all by 2030.

Industry In Different Countries

The U.S. nutraceutical market is one of the world’s largest consumer markets. Organizations and manufacturers are hoping to enhance their items and move towards the inclusion of natural/organic ingredients in their products. Organic ingredients are a demand of U.S. customers, who are incredibly health conscious and consider natural ingredients in the items they consume.

In Europe, Nutraceuticals markets are witnessing promising growth, with a primary focus on the advancement and development of new products. It results in a significant increase in research and development – from 0.19% at the start of the decade to 1 percent in 2012. Countries like Germany, the Netherlands, and Sweden have become the major nutraceutical innovation hubs of Europe, whereas Great Britain and Spain act as critical test markets for new items.

As indicated by a new report, the net market for nutraceuticals in India is developing at more than 20 percent per year. Right now, it is a nascent business sector attempting to join conventional homegrown herbal ingredients into the nutraceutical portfolio. Its development has surpassed worldwide rates lately, driven by beverage and functional food categories.

Nutraceutical Regulation

Natural chemicals are organic compounds with disease­ prevention, health-promoting, and potential healing properties. This classification includes nutrients such as minerals, vitamins, and herbal extracts. Likewise, nutraceuticals additionally include “functional foods” – a food product that provides a particular medical advantage depending on their nutritional profile.

The regulation includes many challenges to the widespread use of nutraceuticals, including their safety, effectiveness, and somewhat dissimilar definition of these nutrients in various countries. For instance, Japanese people define functional foods according to the composition of natural ingredients in the nutraceuticals. Compared to Japan, people in the U.S. also consider biotechnology products as an active ingredient of nutraceuticals. 

The main objectives of nutraceutical regulation have been centered around safety and naming (when compared with drugs). This is cultivated through the regulations designed by Good Manufacturing Practice (GMP) practices and a new expansion in enforcement.

To a great extent, buyers are responsible for deciding the use and worth offered by nutraceuticals. All things considered, expanded regulations related to the safety, quality, and effectiveness of these products will profit the business and help reduce regulatory kickback danger.

Regulatory Rules In Different Countries

Nutraceuticals in the USA are regulated by the Food and Drug Administration (FDA) under an alternate set of guidelines compared to those drugs, medication, and other conventional foods. As per the 1994 DSHEA (Dietary Supplement Health and Education Act), the producer must guarantee the nutraceutical product’s safety and effectiveness before it is marketed and sold in the market.

The FDA is authorized to move against any harmful product in the market. Manufacturers need to ensure that the nutritional data and ingredient information given on the product label is accurate and not misleading. However, product owners are not obliged to get FDA approval or register their items with the FDA before selling nutraceuticals.  

The legislation of nutraceuticals in the European Union is mostly under the umbrella of EFSA (European Food and Safety Authority). This organization primarily focuses on “food supplements,” which are marketed as concentrated nutrient sources (for example, vitamins, proteins, and minerals). Directive 2002/46/E.C. is the principle E.U. legislation to regulate food supplements’ production and selling.

In Europe, new nutritional products and supplements must pass European development and quality requirements. In Australia and Canada, nutraceuticals are placed in the same category as drugs and more closely regulated.

There is no specific legal status ascribed to nutraceuticals according to Indian legislation. These products are regulated under the Food Safety and Standards Act (FSSA) guidelines by India’s government.

Global Market Entry Requirements

In many countries, nutraceuticals are known as a sub-group of food. There is a defined set of regulations and guidelines for food supplements (for example, the U.S., European Union, India, and the Association of Southeast Asian Nations), resulting from food-based regulations. Therefore, these countries require a notification system or pre-registration of the new products before bringing them to the market.

Latin America has various market entry requirements for nutraceuticals. Countries like Colombia, Brazil, and Argentina use registration based approaches while the notification based approach is predominant in Mexico and Chile.

In Taiwan, Brazil, and China, the regulatory authorities require clinical studies based on animals or humans to prove the safety and effectiveness of a new nutraceutical product that is about to launch in the market. The notification based approach in these countries perfectly regulates consumer safety, pre­market resources, and consumer access. Regardless of the pre­market requirements, robust post­-market surveillance is a key aspect to ensure product quality, safety, and effectiveness.

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