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Nutraceuticals – What is the real story?

When we hear the term nutraceutical bounced around, many of us also think of dietary supplements or functional foods. However, the term, which has no meaning in regulations or in the law, was originally conceived in 1989 by Dr. Stephen DeFelice, founder and chairman of the Foundation for Innovation in Medicine (FIM), from the terms “Nutrition” and “Pharmaceutical.” According to DeFelice, a nutraceutical can be defined as a “food” (or part of a food) that provides medical or health benefits. A similar term, also with no legal or regulatory definition, is functional food and is defined by IFT[1] as “foods or food components providing specific health benefits beyond basic nutrition.” Then, as today, these terms may only be used for marketing purposes, but may not appear on a label.

So what is the difference among dietary supplements, food ingredients, and nutraceuticals or functional foods? Dietary supplements are intended to supplement the diet, not replace a meal, and are typically consumed in pill, capsule, tablet, and liquid form. A dietary supplement may not be added to food unless it has also been approved as a food ingredient (i.e., a substance that may be added to food). Any ingredient, whether touted as a functional food or nutraceuticals, may only be added to food once it has been approved via a food additive petition or the generally recognized as safe (GRAS) process. And, although added to foods and marketed to imply that it provides some type of health and/or medical benefit, no statement may be made on the label to this effect.

Over the past decade, nutraceuticals have boomed because of the rising costs of pharmaceuticals and the media hype on how wonderful it is too take something referred to as a “natural medicine.”  But the question to many still remains, “Are they safe?”

First and foremost, proven safety of any dietary supplement or an ingredient added to food (including nutraceuticals) should be based on its intended use and consumption levels and both criteria should have substantiated scientific data to document these safety claims. But, as a consumer, how can you tell?

Any new ingredient after October 15, 1994 must abide by the Dietary Supplement Safety Act (DSHEA) by submission of a New Dietary Ingredient Notification (NDIN) to the FDA. Alternatively, because the rejection rate for NDINs hovers around 70%, many manufacturers are opting to go the route of the Generally Recognized As Safe (GRAS) process because the decision on what is safe is taken out of the hands of the FDA. Also, because the GRAS process involves demonstrating safety to the higher standard of “reasonable certainty of no harm,” many manufacturers have used this “extra” assurance of a safe product as a marketing advantage.

So, will nutraceuticals continue on their path of being the modern-day way to stay healthy? With billions of dollars spent every year by consumers, and with no slow down in sight, it seems evident that more people are choosing nutraceuticals over pharmaceuticals. However, one thing should be on the top of every person’s list when deciding what to produce or consume, and that is “safety first.”


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