Vigilance System for Food Supplements

Bioactive Agents
Bioactive agents are extra-nutritional constituents, naturally present in low concentrations in foods and that have positive effects on health. Penny M. Kris-Etherton, PhD, RD Kari D. Hecker, MS, RD, Andrea Bonanome, MD Stacie M. Coval, MS, Amy E. Binkoski, Bs, RD, Kirsten F. Hilpert, BS, Amy E. Griel, Med, Terry D. Etherton, PhD.

Antioxidants
Antioxidants are substances that act against free radicals and prevent the damage that they cause. They have the ability to reduce adverse effects caused by oxidants, neutralizing them before they reach the biological targets, thus preventing the damaging chain reactions that they trigger, as well as preventing the formation of reactive oxygen species - aggressive to biological structures. A. Azzi, K.J.A Davies, F.Kelly, Free radical biology - terminilogy and critical thinking, FEBS Lett, 588 (2004) 3-6.

Adverse Event
Any unwanted manifestation that occurs in an individual after taking a food supplement or nutraceutical, even if there is no suspicion of a causal link between the event and product.

Unexpected Adverse Event
Any unwanted symptom, not described in the scientific literature felt after taking the food supplement - including symptoms whose nature, intensity or developments differ from those described in the bibliography.

Pharmacovigilance
Study of the safety of drugs in commercialization, and the clinical practices within the community.

Nutraceutical
Nutraceuticals are food supplements used as carriers of bioactive agents in a concentrated form in food. They're used to promote health in dosages that exceed those found in foods. ** Zeisel SH. Regulation of "nutraceutic." Science. 199 9; 285:185-186.

Responsible for marketing
Entity responsible for marketing the food supplement or nutraceutical.

Food supplement
Food intended to supplement the normal diet, and that are concentrated sources of nutrients or other substances with nutritional or physiological effect, alone or combined, marketed in the form assayed, such as capsules, tablets, pills and similar forms, sachets of powder, ampoules, drop dispensing bottles and other similar forms of liquids or powders. "