Screening of Nutraceuticals and Functional Foods

Screening of Nutraceuticals and Functional Foods

1. Definitions, terminology and the evaluation problem

• A functional food has no single globally accepted definition; in broad terms it is a food that provides health benefits beyond basic nutrition — i.e. beyond supplying energy and essential nutrients (Vogel/Hock 4e, Part XVIII, pp.4019–20).
• Drivers for functional-food development: growing evidence for the role of specific foods/ingredients in disease prevention and risk reduction, consumer desire for "self-medication", an ageing developed-world population, and the rising burden of obesity and lifestyle diseases such as type 2 diabetes (Vogel/Hock 4e, Part XVIII, p.4019).
• FOSHU (Food for Specified Health Use) — Japan's MHLW (Ministry of Health, Labour and Welfare) was the first regulator to formally define functional foods (1991); FOSHU = "foods composed of functional ingredients that affect the structure and/or function of the body and are used to maintain or regulate specific health conditions" (e.g. gastrointestinal health, blood pressure, blood cholesterol) (Vogel/Hock 4e, Part XVIII, pp.4019–20).
• FUFOSE (European Commission Concerted Action on Functional Food Science in Europe, 1999) working definition: foods "satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects", relevant to improved health/well-being and/or reduction of disease risk (Vogel/Hock 4e, Part XVIII, p.4019).
  • FUFOSE crucially stipulated that functional foods must remain foods and demonstrate effects at amounts normally consumed in the diet — "not pills or capsules" (Vogel/Hock 4e, Part XVIII, pp.4019–20).
• Contrasting regulatory stances embedded in the definitions (Vogel/Hock 4e, Part XVIII, pp.4020, Table 1):
  • FOSHU (Japan) does not exclude capsule/tablet dosage forms, whereas FUFOSE (Europe) explicitly does — a key scoping difference when designing an evaluation dossier.
  • American Dietetic Association (2009): whole, fortified, enriched or enhanced foods with a potentially beneficial health effect when consumed as part of a varied diet at effective levels.
  • Institute of Medicine — Food & Nutrition Board (IOM/FNB 1994): any food or food ingredient providing a health benefit beyond the traditional nutrients it contains.
  • Health Canada (1998): food similar in appearance to conventional food, consumed as part of the usual diet, with demonstrated physiological benefit and/or reduced chronic-disease risk.
  • FSANZ (Australia/New Zealand): conventional-appearance food modified to serve physiological roles beyond simple nutrient provision.
  • IFIC (2011): foods or dietary components that may provide a health benefit beyond basic nutrition.
• Nutraceutical — nutraceuticals and functional foods are conventionally treated together under the "beyond basic nutrition" umbrella; the discriminating axis is dosage form and claim, not chemistry. India's FSSAI gives the sharpest statutory line (see §12.1): a nutraceutical is a purified/concentrated bioactive presented for a physiological/health benefit, distinct from a health supplement (concentrated nutrient sources in dosage form) and from a drug (FSSAI 2016 Nutraceutical Regulations) [FSSAI].
• The core evaluation problem — unlike a single-molecule drug, a functional food/nutraceutical may be a whole food, a fortified food, or a purified isolate, and often a multi-component matrix of increasing complexity; this dictates that the screening/evaluation strategy must be matrix-dependent, not one-size-fits-all (Vogel/Hock 4e, Part XVIII, pp.4021, 4035).