What is the official definition of a nutraceutical?

December 30, 2025 •

3 min read

Coined in 1989 by Dr. Stephen DeFelice, the term nutraceutical combines 'nutrition' and 'pharmaceutical,' yet no single, official definition exists, causing market and regulatory confusion. This uncertainty impacts how these health products are classified and marketed around the world.

Quick Summary

There is no official, universal definition for a nutraceutical; its meaning varies by region and context. Regulatory bodies like the FDA classify products based on their ingredients and claims, often as dietary supplements, while the term itself lacks legal standing in many places.

Key Points

No Official Definition: There is no single, universally agreed-upon official or legal definition of a nutraceutical.
Term's Origin: The term was coined by Dr. Stephen DeFelice in 1989, merging 'nutrition' and 'pharmaceutical' to describe food-derived products with health benefits.
Regulatory Confusion: Regulation is a global patchwork; in the U.S., the FDA does not define the term and regulates products based on ingredients and claims, often as dietary supplements.
Difference from Supplements: Unlike dietary supplements, which address nutritional gaps, nutraceuticals are conceptually linked to broader medical or health benefits, though the regulatory line is often blurred.
Evidence is Key: Due to variable oversight, consumers must rely on scientific evidence rather than marketing claims to assess the safety and efficacy of nutraceutical products.

The Origin of a Concept, Not a Law

The term "nutraceutical" is a portmanteau created in 1989 by Dr. Stephen DeFelice. He defined it as "a food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease". This concept was inspired by the ancient idea of food as medicine. The term was intended for scientific and marketing use, not legal regulation, which contributes to the current confusion regarding its official definition.

The Lack of a Universal Official Definition

Despite its widespread use in marketing and scientific discussions, there is no single, globally recognized, and legally binding official definition for the term "nutraceutical". This lack of standardization can lead to ambiguous claims and makes regulation challenging. Some experts suggest replacing the term with more precise classifications due to the absence of internationally defined properties. How a product is classified often depends on its location and the health claims made about it.

Regulatory Status: A Global Patchwork

United States (FDA) Perspective

In the U.S., the Food and Drug Administration (FDA) does not legally recognize "nutraceuticals". Products are regulated based on their composition and intended use, primarily under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, manufacturers are responsible for product safety and ensuring claims are truthful. Unlike pharmaceuticals, dietary supplements do not require pre-market FDA approval. Health claims are limited to structure/function benefits (e.g., "supports bone health") and cannot claim to treat or prevent disease without specific approval. Products must include a disclaimer stating the FDA has not evaluated the claim.

International Regulatory Approaches

Nutraceutical regulation varies significantly worldwide:

Canada: Defines a nutraceutical as a food-derived product in medicinal form with a physiological benefit, though it holds no distinct legal status from functional foods.
European Union: Focuses on "food supplements" and requires health claims to be reviewed and authorized by the European Food Safety Authority (EFSA).
India: Regulates nutraceuticals through the Food Safety and Standards Authority of India (FSSAI), requiring a license for sales.

Key Distinctions: Nutraceuticals, Functional Foods, and Supplements

Understanding the differences between these terms is crucial. They are distinguished by their format, purpose, and regulatory handling.


Feature	Nutraceuticals	Dietary Supplements	Functional Foods
Format	Isolated compounds (pills, capsules), or modified foods	Tablets, capsules, softgels, powders, liquids	Whole foods or fortified foods
Source	Derived from food sources	Can be from food or chemical synthesis	Natural, unprocessed foods with inherent benefits
Purpose	Prevention/treatment of disease (DeFelice's concept)	Supplementing the diet to address nutrient deficiencies	Providing extra health benefits beyond basic nutrition
Regulatory	Term lacks official definition in U.S. and many regions; regulated based on claims	Regulated as a category of food under DSHEA in the U.S.	Regulated as conventional foods, with health claims subject to scrutiny

Classifications and Examples of Nutraceuticals

Nutraceuticals can be categorized by their active components. Examples include:

Dietary Fiber: Beta-glucan from oats for cholesterol.
Probiotics and Prebiotics: Support gut health.
Polyunsaturated Fatty Acids (PUFAs): Omega-3s for heart/brain health.
Antioxidants and Polyphenols: Curcumin, resveratrol, combating oxidative stress.
Herbal and Botanical Extracts: Plant extracts like echinacea or ashwagandha.

The Importance of Evidence and Safety

Consumers must be cautious when it comes to nutraceuticals, as marketing claims may not always be supported by clinical evidence. Safety and efficacy evaluations can be less stringent than for pharmaceuticals. It is vital to research ingredients, review scientific evidence, and consult healthcare professionals before use. Reputable sources like the NIH can help distinguish evidence-based claims from promotional hype.

Conclusion: Navigating the Grey Area

In conclusion, "nutraceutical" is a conceptual term for health products derived from food, lacking a unified legal definition globally and in the U.S.. This creates a complex regulatory environment where products are classified based on ingredients and claims. Consumers should look beyond the term and understand specific product components, intended uses, and supporting scientific evidence to make informed choices. Distinguishing between nutraceuticals, dietary supplements, and functional foods is key to navigating this market safely.

Frequently Asked Questions

The term "nutraceutical" was coined by Dr. Stephen DeFelice in 1989. He is the founder and chairman of the Foundation for Innovation in Medicine.

In the U.S., the FDA does not officially define "nutraceuticals." The products are typically regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which classifies them as a subset of food.

No, nutraceuticals sold as dietary supplements do not require FDA approval before they are marketed. The manufacturer is responsible for ensuring the product's safety and the accuracy of its claims.

A functional food is a fortified or enriched food product consumed as part of a regular diet. A nutraceutical is often an isolated or purified compound sold in medicinal forms like pills, though the two terms are sometimes used interchangeably.

A dietary supplement is intended to supplement the diet and fill nutrient gaps, while a nutraceutical is conceptualized as a product offering broader health or medicinal benefits. The regulatory differences vary globally, but dietary supplements in the U.S. are regulated under DSHEA.

Common examples include omega-3 fatty acids from fish oil, probiotics from fermented foods, curcumin from turmeric, and beta-glucan from oats and barley.

No. In the U.S., a product regulated as a dietary supplement cannot claim to cure, treat, or prevent a specific disease. It can only make structure/function claims, such as "supports heart health," and must carry an FDA disclaimer.