Nutraceuticals, representing a combination of food and medicine, are an important part of the global health and wellness movement. They are intended to provide more than just basic nutrition; they are intended for benefits such as health promotion or reducing the risk of disease. With increasing consumer interest, the market for nutraceuticals has expanded substantially, as consumers increasingly prefer nutraceutical product development focused on health-conscious natural products over pharmaceuticals when possible.

Nutraceuticals – Definitions, Classification, and Global Insights

Regulation Sept 19, 2025

Nutraceuticals, representing a combination of food and medicine, are an important part of the global health and wellness movement. They are intended to provide more than just basic nutrition; they are intended for benefits such as health promotion or reducing the risk of disease. With increasing consumer interest, the market for nutraceuticals has expanded substantially, as consumers increasingly prefer nutraceutical product development focused on health-conscious natural products over pharmaceuticals when possible.  

Despite the popularity and growing market of nutraceuticals, the word nutraceutical is not universally defined meaning countries have varying definitions, regulations and classifications of nutraceuticals.

Regional variances:

  • United States (FDA): Uses the term Dietary Supplement, including vitamins; minerals; herbs and botanicals (which also includes blended dietary ingredients); and amino acids (FD&C Act). [2]
  • European Union (EFSA): Reviews health claims on food or food products including supplements under Directive 2002/46, which defines supplements as concentrated sources of nutrients or other substances with physiological benefit. [3]
  • India (FSSAI): Nutra products includes any food as well as extracts with a beneficial physical impact or modality that assists in disease prevention or treatment of diseases. The nutrient levels must adhere to RDA (FSS Act, 2006). [4]
  • Canada (Health Canada): Uses the term functional foods meaning food or health products that provide other benefits above and beyond the basic nutrition.
  • WHO & USDA: Nutrition can have a role in health in the promotion and prevention of disease.
  • IFIC & NIN: define nutraceuticals as bioactive components of food with positive health effects including disease prevention and treatment.
In general, nutraceuticals are designed to focus on health effects that go beyond dietary relevance, often serving as a platform for nutraceutical product innovation and formulation.

Classification of Nutraceuticals

Nutraceuticals are grouped by source and processing:

  1. Traditional Foods (Natural Source)

Chemical Constituents:

  • Nutrients: vitamins, minerals, amino acids, and fatty acids
  • Herbals: plant remedy to support chronic disease (ex. turmeric, ginseng)
  • Phytochemicals: bioactive plant compounds which may support health (ex. lycopene, saponins)
  • Nutraceutical Enzymes: extracts derived from plants, animals or microbes to support digestion, metabolism, and disease
  • Probiotic Microorganisms: live microorganisms that may support gut health and immunity
  1. Non-Traditional Foods (Biotechnologically enhanced)
  • Fortified Nutraceuticals: food with added nutrients (ex. vitamin-enhanced cereals, milk fortified with vitamin D)
  • Recombinant Nutraceuticals: food products created using genetic technology (ex. milk with recombinant lactoferrin)
  1. Functional Foods: foods to which bioactive ingredients have been added, naturally or artificially, to provide health benefits (ex. foods with probiotics – yogurt or milk with omega-3)
  2. Medicinal Foods: dietary management of disease under the supervision of the physician (ex. meal replacement or health bars with added medication)
  3. Dietary Supplements: orally taken products that contain or are concentrated nutrients or bioactive substance to supplement the diet (ex. vitamins, minerals, herbal extracts). [5]

This classification forms the foundation for nutraceutical product design, guiding researchers and companies in creating targeted health solutions.

Classification of Nutraceuticals

Ethical Considerations and Consumer Protection

The nutraceutical industry continues to grow quickly, and as the market grows, so grows the responsibility to assure ethical and safe marketing of nutraceutical products. Nutraceutical companies must take the responsibility of being honest and clear on the benefits and risks of their products.

  1. Health Claims and Transparency 

While nutraceuticals are relatively new and their marketing takes place in a complex and diverse environment, ethical marketing requires that all health claims made involving nutraceuticals must be grounded in science. Companies must not make exaggerated or untruthful claims. Exaggerated and untruthful claims can mislead a consumer into believing the product can cure diseases, or some other unverified health benefit. [6]

Nutraceuticals – Definitions, Classification, and Global Insights

2. Consumer Safety

EU, US, and Indian regulatory agencies (such as FDA, EFSA, and FSSAI) require nutraceutical companies to engage in significant product safety testing to assure consumers that products do not cause harmful effects. Ethical responsibility means conducting clinical trials and truthful product labeling efforts to assure a consumer can make an informed decision as to product safety. [7]

3. Reporting adverse reactions

Each nutraceutical company must have a system in place to report any adverse reactions attributed to its products. This is an essential aspect of consumer protection and product safety.

Definition of Nutraceuticals

Nutraceuticals have evolved from their conceptual basis as food-based items to include health food products that provide nutritional, therapeutics, and medicinal benefits. [1]

  • Nutraceutical: food or food ingredient with therapeutic and/or nutritional and/or medicinal benefits that conveys a health benefit above and beyond that of normal nutrition by potentially preventing or treating disease. Other names for nutraceuticals are dietary supplements, multipurpose food products, or functional foods.
  • Functional foods: foods that include other dietary components to provide benefits above and beyond ordinary foods.

Future Trends in Nutraceuticals

The nutraceutical industry is likely to grow as the consumer demand for functional foods and supplements is ever-expanding. Expect to see some key trends, such as:

  1. Personalized Nutrition: Advances in genomics and biotechnology will enable nutraceutical product development tailored to individual health needs and genetic profiles.
  2. Plant-Based Nutraceuticals: As consumers become the most health conscious and environment concerns rise, many will opt to utilize plant-based nutraceuticals, including plant proteins and plant-based dietary supplements. [8]
  3. Probiotics and Gut Health: The growth of interest around probiotics and gut microbiota and its implications on health will continue to fuel the growth of interest in gut health supplements or functional foods.
  4. Sustainability: Consumers increasingly value sustainable sourcing and production methods, influencing health-conscious product development strategies.

Product Example: Food Research Lab® Omega-3 Softgel Supplements

Overview:

A dietary supplement supporting heart, cognitive, and overall health, developed with scientific rigor and compliant with global regulations.

  1. Nutraceutical Definition:
  • Category: Dietary Supplement (Omega-3 Softgel)
  • Definition: Provides bioactive compounds beyond basic nutrition for targeted health benefits.
  1. Regulatory Requirements:
  • FDA (USA): DSHEA-compliant with labeling and GMP adherence.
  • EFSA (EU): Food supplement with validated health claims.
  • FSSAI (India): Licensed under FSDU with approved health claims.
  • Health Canada: Regulated as NHP with science-backed claims.
  1. Ethical Considerations:
  • Health claims are evidence-based.
  • Comprehensive safety testing ensures consumer protection.
  • Adverse reactions monitored through established reporting protocols.
  1. Future Directions:
  • Personalized omega-3 supplements based on health or genetics.
  • Plant-based vegan softgels using algae oils.
  • Sustainable packaging and ingredient sourcing.
  1. Consumer Education:

Educational content highlights the benefits of omega-3 for heart, brain, and overall wellness.

Conclusion:

Food Research Lab® Omega-3 Softgel delivers safe, scientifically validated, and effective nutrition, combining innovation, compliance, and consumer education.

Ethical Marketing of Nutraceuticals

It is an ethical dilemma in how to market nutraceuticals in a highly competitive environment and ensure that products are not misrepresented. The fundamentals of ethical marketing must include the following points:

  1. Scientific Back-up: All health claims will be backed up by science or clinical trials.
  2. Labeling: Labels must be honest to the product as they are encompassing the ingredients, intoxication, and dosage.
  3. Advertising: Advertising must not mislead consumers; everyone’s claims must be factual and not exaggerated.

Consumer Education and Awareness

Consumer education is important in enabling the responsible use of nutraceuticals.

  1. Providing Timely Information: Businesses should allocate resources towards the education of their consumers towards the benefits and drawbacks of their nutraceutical products.
  2. Transparency: Businesses should value transparency and thereby facilitate consumer education, and this includes open communication about the sourcing of ingredients, how effective their products are in achieving their own claims, and doing all of this in response to regulatory requirements.
  3. Awareness: Governments and industry associations should assist with promoting awareness of the safe use of nutraceuticals and empowering consumers to choose nutraceuticals which are scientifically based. [9]

Conclusion

Nutraceuticals represent a dynamic intersection between food and medicine, providing consumers with products that promote overall health and wellness. However, inconsistent definitions and regulations across regions pose challenges to consumer safety and ethical marketing. As the market grows, the importance of nutraceutical product innovation and formulation, nutraceutical product design, and health-conscious product development becomes ever more critical.

Conclusion

Nutraceuticals represent a dynamic intersection between food and medicine, providing consumers with products that promote overall health and wellness. However, inconsistent definitions and regulations across regions pose challenges to consumer safety and ethical marketing. As the market grows, the importance of nutraceutical product innovation and formulation, nutraceutical product design, and health-conscious product development becomes ever more critical.