The term “nutraceutical” refers to any standardized, pharmaceutical-grade nutrient used as a dietary supplement or food additive. The most common nutraceutical compounds include vitamins, minerals, botanicals, extracts, proteins, amino acids, and enzymes. At the consumer level, nutraceuticals fill entire aisles and stores with common supplements including Omega-3 fish oils, lutein, Echinacea, glucosamine, melatonin, curcumin, and green tea extracts. Although the term nutraceutical is not a discrete category recognized by FDA, nutraceuticals are regulated as food supplements and additives. As the world populace clamors for ever-expanding alternatives to improve performance, reduce symptoms, and prevent disease, the nutraceutical industry has expanded exponentially in recent years.
Coincident with the expansion has come increasing FDA scrutiny over labelling claims and product safety. Nutraceutical labels must have labeling that accurately reflects the product’s benefits without misleading the consumer. Inaccurate, overzealous, or outright spurious health claims will lead to FDA scrutiny, as will the absence of appropriate disclaimers. The products themselves must also be safe for consumption, a point well-illustrated by the L-tryptophan disaster that led to over 2000 lawsuits in the late 1980’s.
Given the inherent diversity of dietary supplements and additives, expert witnesses in nutraceutical litigation span the gamut from Sports Physiology to Pharmacology and Medical Toxicology.