RESEARCH STARTER

Nutraceutical

Nutraceuticals are products derived from food sources that offer nutritional or health benefits beyond basic nutrients. Often referred to as nutritional supplements, medical foods, functional foods, or designer foods, nutraceuticals encompass items like fortified breakfast cereals, enhanced yogurts, and various dietary supplements such as fish oil or herbal capsules. The term was introduced in 1989 by Dr. Stephen DeFelice, merging "nutrition" and "pharmaceutical." This concept is rooted in ancient practices that advocate for food's healing properties, with historical examples of fortified foods aimed at preventing deficiencies.

Nutraceuticals are categorized into functional foods, dietary supplements, and medical foods. Functional foods provide health benefits through whole or fortified foods; dietary supplements deliver concentrated nutrients in various forms; and medical foods are utilized under medical supervision to manage specific health conditions. Regulatory bodies, such as the USDA and FDA in the United States, oversee these products, assessing the validity of health claims based on clinical trials. While nutraceuticals can offer milder side effects compared to pharmaceuticals, consumers should exercise caution and critically evaluate the claims associated with these products, as the distinction between food and medicine can sometimes blur, potentially leading to health risks.

Full Article

The term nutraceutical refers to any product derived from a food source that is consumed because it provides nutritional or health benefits above and beyond the basic nutrients found in food. Nutraceuticals are sometimes called nutritional supplements, medical foods (although medical foods are intended to treat a particular condition’s specific nutritional requirement and nutraceuticals are often generally broad in their application), functional foods (although nutraceuticals are refined or concentrated products derived from foods rather than the whole functional food), or designer foods. Nutraceuticals include the extra vitamins and minerals that fortify breakfast cereals and breads, the live cultures added to enhance some yogurts, and supplements such as fish oil and various herbs consumed in capsule form. People ingest nutraceuticals because they believe they will prevent or treat a disease, strengthen an area of the body, or simply provide better nutrition to support the body’s overall health.

Background

The word “nutraceutical” came into use in 1989 as an invention of American doctor Stephen DeFelice. The founder of the Foundation for Innovation in Medicine (FIM), DeFelice combined the words “nutrition” and “pharmaceutical” to make the new word, which has since been entered into The Oxford English Dictionary.

While the name was new, the idea of fortifying food to make it healthier was not. For example, since 1924, salt has been fortified with iodine. This was originally done to combat iodine deficiencies that caused goiter, an abnormal enlargement of the thyroid gland. However, the practice continued because iodine aids in brain development. Vitamin D has been added to milk since 1933 to prevent rickets, a childhood bone disorder, and later as a way to strengthen bones. When the US government noticed that many men enlisting for World War II suffered from nutritional deficiencies, it passed laws requiring that food such as bread and cereal be fortified with various vitamins and minerals. However, these laws were later repealed, and in the late 1940s, the US Food and Drug Administration (FDA) no longer required mandatory fortification. In the 1960s, the FDA proposed stricter rules proposing a maximum for fortification at the recommended daily dose for each supplement to keep food manufacturers from over-supplementing to make their product seem superior to others. However, the regulations were overturned in the 1970s. Although fortification policies have changed, the US federal standards for some enriched foods, including enriched flour and enriched bread, remain in place.

The idea of eating good food for better health is centuries old; Greek physician Hippocrates (460–375 BCE) reportedly stated, “Let food be your medicine.” By the time DeFelice coined the term nutraceutical in 1989, scientists had learned how many foods affected the body. As a result, interest grew in using food as a way to enhance or improve health.

Overview

Nutraceuticals are grouped into categories, usually based on their source. These categories include functional foods, dietary supplements, and medical foods. The foods in each category are used for a specific purpose.

Functional foods are whole foods or fortified foods that are consumed for the ways in which they benefit a person’s health. For example, some foods, such as salmon and nuts, contain omega-3 fatty acids, which the body cannot make them directly but are necessary for healthy brain function. Omega-3 fatty acids are also thought to improve the cardiovascular system and limit or reduce inflammation.

Dietary supplements are usually consumed as pills, capsules, liquids, or powders. They contain concentrated amounts of specific nutrients from food. For example, omega-3 fatty acids are available as dietary supplements. People either take these supplements in place of eating certain foods or in addition to eating them.

Medical foods are those that are eaten or administered under the supervision of a physician. They are usually prescribed to help manage a disease or condition that has distinct nutritional requirements. For example, a patient may consume certain medical foods because they have a digestive problem. Medical foods also include nutritional liquids taken to supplement oral food for people with a condition that makes it difficult for them to take in enough calories through solid food. In the twenty-first century, advancements in nutrigenomics—how genes influence response to nutrients—began a trend toward personalized nutraceuticals tailored to an individual’s DNA.

In most countries, each of these categories is subject to at least some regulation as to the nature of the product and the claims that can be made about its benefits. In the United States, the Dietary Supplement Health and Education Act of 1994 regulates these products, with the manufacturers ensuring good manufacturing practices, with the FDA possibly reviewing just the new dietary ingredients. The appropriate government agency will use the test results to determine if a nutraceutical claim is valid.

The FDA and the Federal Trade Commission (FTC) review nutraceutical claims in the United States and determine if they are valid. For example, if a growers’ association wants to claim its fruit is heart-healthy, government authorities will evaluate the claim to determine if the evidence supports it. In the United States, advertisers are responsible for having solid scientific support for health claims. The FTC actively monitors the marketplace, and it can take action when claims are unsupported. If sufficient scientific evidence exists, the FTC allows the advertising claim. If the claim lacks scientific proof, the growers’ association must complete a revision of the statement or their growing methods. Similar agencies oversee health claims for products in other countries. However, these agencies do not regulate nutraceuticals like they regulate medicines. Third-party testing can help verify product safety, but misleading claims are a persistent problem; consumers should rely on scientific evidence rather than marketing. In 2025, the FDA issued an industry letter stating that the required Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer should appear on dietary supplement labels.

In many cases, the side effects of nutraceuticals are milder. Nutraceuticals also offer an advantage to manufacturers or producers because they are not subjected to the longer, more costly trials required for pharmaceuticals.

However, nutraceuticals straddle a line between food and medicine, so it can be difficult to detect whether an oversight has been made in determining their safety. It is possible for products that present a danger to enter the market without sufficient review, presenting a health risk. Some supplements have been found to contain heavy metals, undeclared pharmaceuticals, or harmful additives, and some seemingly safe nutraceuticals interact with prescription medications, leading to serious health risks. Many nutraceuticals lack standardization, meaning doses may vary between batches. Consumers must be cautious in determining the validity of the claims made about these products, particularly dietary supplements. Since 2023, the FDA has expanded tools, including its directory of ingredients used in products marketed as dietary supplements, as part of broader efforts to strengthen oversight of the supplement market. In 2026, the National Institutes of Health (NIH) updated evidence-based guidance on products such as probiotics, indicating which products may help in specific situations and which claims remain unsupported.


Bibliography

Baker, Sheldon. “An Interview with Dr. Stephen DeFelice.” Nutraceuticals World, 28 Oct. 2011, www.nutraceuticalsworld.com/an-interview-with-dr-stephen-defelice. Accessed 24 Mar. 2026.

Bull, Esther, et al. “What Is a Nutraceutical?” Pharmaceutical Journal, 22 Mar. 2021, pharmaceutical-journal.com/article/ld/1-what-is-a-nutraceutical. Accessed 24 Mar. 2026.

“Enriched Flour.” Electronic Code of Federal Regulations, Title 21, sec. 137.165, U.S. Government Publishing Office, www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-137/subpart-B/section-137.165. Accessed 24 Mar. 2026.

“Food, Supplement, or Drug? What to Make of Nutraceutical Claims.” Consumer Reports, July 2011, www.consumerreports.org/cro/2012/04/food-supplement-or-drug/index.htm. Accessed 24 Mar. 2026.

“Health Claims.” Federal Trade Commission, www.ftc.gov/business-guidance/advertising-marketing/health-claims. Accessed 24 Mar. 2026.

Hughes, Elinor. “Food with a Function.” Chemistry World, 7 Sept. 2012, www.chemistryworld.com/features/food-with-a-function/5397.article. Accessed 24 Mar. 2026.

Institute of Medicine (US). Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification. National Academies Press, 2003.

“Letter to the Dietary Supplement Industry Regarding the DSHEA Disclaimer.” U.S. Food and Drug Administration, www.fda.gov/food/information-industry-dietary-supplements/letter-dietary-supplement-industry-dshea-disclaimer. Accessed 24 Mar. 2026.

“Medical Foods: Guidance Documents & Regulatory Information.” U.S. Food and Drug Administration, www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/medical-foods-guidance-documents-regulatory-information. Accessed 24 Mar. 2026.

Mestrovic, Tomislav. “What Are Nutraceuticals?” News Medical Life Sciences, 26 Nov. 2022, www.news-medical.net/health/What-are-Nutraceuticals.aspx. Accessed 24 Mar. 2026.

“Office of Dietary Supplements.” National Institutes of Health, ods.od.nih.gov/. Accessed 24 Mar. 2026.

Palthur, M. P., et al. “Nutraceuticals: A Conceptual Definition.” International Journal of Pharmacy and Pharmaceutical Sciences, vol. 2, no. 3, 2010, pp. 19–27.

Varghese, Tincy, and P. Mishal. “Scrutinizing the Term ‘Nutraceutical’—a Global Regulatory Perspective.” Nutraceutical Business Review, 21 July 2014, nutraceuticalbusinessreview.com/scrutinising-the-term-nutraceutical-a-global-regulatory-perspective-100047. Accessed 24 Mar. 2026.

“What’s New in Dietary Supplements.” U.S. Food and Drug Administration, www.fda.gov/food/dietary-supplements/whats-new-dietary-supplements. Accessed 24 Mar. 2026.

Full Article

The term nutraceutical refers to any product derived from a food source that is consumed because it provides nutritional or health benefits above and beyond the basic nutrients found in food. Nutraceuticals are sometimes called nutritional supplements, medical foods (although medical foods are intended to treat a particular condition’s specific nutritional requirement and nutraceuticals are often generally broad in their application), functional foods (although nutraceuticals are refined or concentrated products derived from foods rather than the whole functional food), or designer foods. Nutraceuticals include the extra vitamins and minerals that fortify breakfast cereals and breads, the live cultures added to enhance some yogurts, and supplements such as fish oil and various herbs consumed in capsule form. People ingest nutraceuticals because they believe they will prevent or treat a disease, strengthen an area of the body, or simply provide better nutrition to support the body’s overall health.

Background

The word “nutraceutical” came into use in 1989 as an invention of American doctor Stephen DeFelice. The founder of the Foundation for Innovation in Medicine (FIM), DeFelice combined the words “nutrition” and “pharmaceutical” to make the new word, which has since been entered into The Oxford English Dictionary.

While the name was new, the idea of fortifying food to make it healthier was not. For example, since 1924, salt has been fortified with iodine. This was originally done to combat iodine deficiencies that caused goiter, an abnormal enlargement of the thyroid gland. However, the practice continued because iodine aids in brain development. Vitamin D has been added to milk since 1933 to prevent rickets, a childhood bone disorder, and later as a way to strengthen bones. When the US government noticed that many men enlisting for World War II suffered from nutritional deficiencies, it passed laws requiring that food such as bread and cereal be fortified with various vitamins and minerals. However, these laws were later repealed, and in the late 1940s, the US Food and Drug Administration (FDA) no longer required mandatory fortification. In the 1960s, the FDA proposed stricter rules proposing a maximum for fortification at the recommended daily dose for each supplement to keep food manufacturers from over-supplementing to make their product seem superior to others. However, the regulations were overturned in the 1970s. Although fortification policies have changed, the US federal standards for some enriched foods, including enriched flour and enriched bread, remain in place.

The idea of eating good food for better health is centuries old; Greek physician Hippocrates (460–375 BCE) reportedly stated, “Let food be your medicine.” By the time DeFelice coined the term nutraceutical in 1989, scientists had learned how many foods affected the body. As a result, interest grew in using food as a way to enhance or improve health.

Overview

Nutraceuticals are grouped into categories, usually based on their source. These categories include functional foods, dietary supplements, and medical foods. The foods in each category are used for a specific purpose.

Functional foods are whole foods or fortified foods that are consumed for the ways in which they benefit a person’s health. For example, some foods, such as salmon and nuts, contain omega-3 fatty acids, which the body cannot make them directly but are necessary for healthy brain function. Omega-3 fatty acids are also thought to improve the cardiovascular system and limit or reduce inflammation.

Dietary supplements are usually consumed as pills, capsules, liquids, or powders. They contain concentrated amounts of specific nutrients from food. For example, omega-3 fatty acids are available as dietary supplements. People either take these supplements in place of eating certain foods or in addition to eating them.

Medical foods are those that are eaten or administered under the supervision of a physician. They are usually prescribed to help manage a disease or condition that has distinct nutritional requirements. For example, a patient may consume certain medical foods because they have a digestive problem. Medical foods also include nutritional liquids taken to supplement oral food for people with a condition that makes it difficult for them to take in enough calories through solid food. In the twenty-first century, advancements in nutrigenomics—how genes influence response to nutrients—began a trend toward personalized nutraceuticals tailored to an individual’s DNA.

In most countries, each of these categories is subject to at least some regulation as to the nature of the product and the claims that can be made about its benefits. In the United States, the Dietary Supplement Health and Education Act of 1994 regulates these products, with the manufacturers ensuring good manufacturing practices, with the FDA possibly reviewing just the new dietary ingredients. The appropriate government agency will use the test results to determine if a nutraceutical claim is valid.

The FDA and the Federal Trade Commission (FTC) review nutraceutical claims in the United States and determine if they are valid. For example, if a growers’ association wants to claim its fruit is heart-healthy, government authorities will evaluate the claim to determine if the evidence supports it. In the United States, advertisers are responsible for having solid scientific support for health claims. The FTC actively monitors the marketplace, and it can take action when claims are unsupported. If sufficient scientific evidence exists, the FTC allows the advertising claim. If the claim lacks scientific proof, the growers’ association must complete a revision of the statement or their growing methods. Similar agencies oversee health claims for products in other countries. However, these agencies do not regulate nutraceuticals like they regulate medicines. Third-party testing can help verify product safety, but misleading claims are a persistent problem; consumers should rely on scientific evidence rather than marketing. In 2025, the FDA issued an industry letter stating that the required Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer should appear on dietary supplement labels.

In many cases, the side effects of nutraceuticals are milder. Nutraceuticals also offer an advantage to manufacturers or producers because they are not subjected to the longer, more costly trials required for pharmaceuticals.

However, nutraceuticals straddle a line between food and medicine, so it can be difficult to detect whether an oversight has been made in determining their safety. It is possible for products that present a danger to enter the market without sufficient review, presenting a health risk. Some supplements have been found to contain heavy metals, undeclared pharmaceuticals, or harmful additives, and some seemingly safe nutraceuticals interact with prescription medications, leading to serious health risks. Many nutraceuticals lack standardization, meaning doses may vary between batches. Consumers must be cautious in determining the validity of the claims made about these products, particularly dietary supplements. Since 2023, the FDA has expanded tools, including its directory of ingredients used in products marketed as dietary supplements, as part of broader efforts to strengthen oversight of the supplement market. In 2026, the National Institutes of Health (NIH) updated evidence-based guidance on products such as probiotics, indicating which products may help in specific situations and which claims remain unsupported.


Bibliography

Baker, Sheldon. “An Interview with Dr. Stephen DeFelice.” Nutraceuticals World, 28 Oct. 2011, www.nutraceuticalsworld.com/an-interview-with-dr-stephen-defelice. Accessed 24 Mar. 2026.

Bull, Esther, et al. “What Is a Nutraceutical?” Pharmaceutical Journal, 22 Mar. 2021, pharmaceutical-journal.com/article/ld/1-what-is-a-nutraceutical. Accessed 24 Mar. 2026.

“Enriched Flour.” Electronic Code of Federal Regulations, Title 21, sec. 137.165, U.S. Government Publishing Office, www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-137/subpart-B/section-137.165. Accessed 24 Mar. 2026.

“Food, Supplement, or Drug? What to Make of Nutraceutical Claims.” Consumer Reports, July 2011, www.consumerreports.org/cro/2012/04/food-supplement-or-drug/index.htm. Accessed 24 Mar. 2026.

“Health Claims.” Federal Trade Commission, www.ftc.gov/business-guidance/advertising-marketing/health-claims. Accessed 24 Mar. 2026.

Hughes, Elinor. “Food with a Function.” Chemistry World, 7 Sept. 2012, www.chemistryworld.com/features/food-with-a-function/5397.article. Accessed 24 Mar. 2026.

Institute of Medicine (US). Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification. National Academies Press, 2003.

“Letter to the Dietary Supplement Industry Regarding the DSHEA Disclaimer.” U.S. Food and Drug Administration, www.fda.gov/food/information-industry-dietary-supplements/letter-dietary-supplement-industry-dshea-disclaimer. Accessed 24 Mar. 2026.

“Medical Foods: Guidance Documents & Regulatory Information.” U.S. Food and Drug Administration, www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/medical-foods-guidance-documents-regulatory-information. Accessed 24 Mar. 2026.

Mestrovic, Tomislav. “What Are Nutraceuticals?” News Medical Life Sciences, 26 Nov. 2022, www.news-medical.net/health/What-are-Nutraceuticals.aspx. Accessed 24 Mar. 2026.

“Office of Dietary Supplements.” National Institutes of Health, ods.od.nih.gov/. Accessed 24 Mar. 2026.

Palthur, M. P., et al. “Nutraceuticals: A Conceptual Definition.” International Journal of Pharmacy and Pharmaceutical Sciences, vol. 2, no. 3, 2010, pp. 19–27.

Varghese, Tincy, and P. Mishal. “Scrutinizing the Term ‘Nutraceutical’—a Global Regulatory Perspective.” Nutraceutical Business Review, 21 July 2014, nutraceuticalbusinessreview.com/scrutinising-the-term-nutraceutical-a-global-regulatory-perspective-100047. Accessed 24 Mar. 2026.

“What’s New in Dietary Supplements.” U.S. Food and Drug Administration, www.fda.gov/food/dietary-supplements/whats-new-dietary-supplements. Accessed 24 Mar. 2026.

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