Global Advisory Services, Healthcare Consulting

Nutraceuticals Defined

The term "nutraceutical" was coined from "nutrition" and "pharmaceutical" in 1989 by Stephen DeFelice, MD, founder and chairman of the Foundation for Innovation in Medicine in Cranford, NJ. Nutraceuticals are generally defined as any food or food ingredient that is considered to have a beneficial effect on health. The term has since been adopted by the food marketing industry to describe any food product or supplement that may have a functional or physiological effect that may be beneficial.

As a result, the description nutraceutical is broadly used and can refer to anything from a vitamin supplement pill, to an energy enhancing drink, and more recently to foods which are claimed to have beneficial physiological effects. The following offers specific examples of the types of nutraceuticals available in the four major categories:

Dietary Supplements

Herbs or Botanicals

Functional Foods

Medicinal Foods

Although by definition nutraceuticals are classified as food products, use of the term nutraceutical and the claims attributed to their properties often leads to some disagreement as to whether nutraceuticals should be classified as medicinal products. While this may change in the future, current regulations do not require the same government efficacy and testing standards mandated for pharmaceuticals and other medicinal products.

However, nutraceutical manufacturers are limited to "health claims" about their products and not "medicinal claims." If a manufacturer implies a claim about a nutraceutical's medicinal benefit, the product is required to comply with the same regulatory requirements for medicinal products with respect to safety, efficacy, testing, and marketing.