As a pharmaceutical consultant and a long-standing member of the American Association of Pharmaceutical Scientists (AAPS), I was very interested in the Opinion article authored by Larry Augsburger.1 His goal to strive to ensure nutraceutical/dietary supplement product quality, standardization, safety, efficacy, and purity is laudable, and who can disagree with that. However, I believe my colleague missed a most important point in any discussion of these products, and that is the scientific definition of a dietary supplement or nutraceutical as compared to a drug requiring Food and Drug Administration review and approval based on scientific studies before marketing to consumers.
To call melatonin, hypericin (St. John's wort), and DHEA, for example, dietary supplements or nutraceuticals under the umbrella of the Dietary Supplement Health and Education Act of 1994 is highly questionable. Because a marketer so labels products containing these active pharmacological agents as "dietary supplements" or "nutraceuticals," it is apparently ...