Guidelines on supplements
Looking for better health?
All of us want to feel better, but the modes and methods of execution are different. Some people are looking for easier solution like a PILL, however the others try to change the life style with better, more nutrient dense foods, more regular and more strenuous exercise and proper supplementation.
The principle, “Let food be thy medicine, and medicine be thy food”, advocated by Hippocrates (460–377 BC), the well-recognized father of modern medicine, emphasizes the synergy between nutrient dense food and human health.
Today we will concentrate on regulatory body for supplements or nutraceuticals, term, introduced by Dr. Stephen DeFelice, founder and chairman of the Foundation of Innovation in Medicine in around 2000. Dr. DeFelice defines nutraceutical as any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.
Simply, Nutraceuticals means, NUTRITIVE + PHARMACEUTICAL: A food stuff (as a fortified food or dietary supplement) that provides health benefits.
It is a dietary or herbal supplement that contains products derived from food and natural sources. Popular types of supplements include, but are not limited to, weight loss and weight management supplements, memory and focus enhancers, and sports nutrition supplements.
Nutraceuticals are natural, bioactive chemical compounds that have health-promoting, disease-preventing or general medicinal properties. This category encompasses vitamins, minerals, herbal supplements, and certain animal products. In addition, nutraceuticals also include “functional foods” – i.e. foods that tout a specific health benefit based on their ingredients
In the USA, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of rules when compared with those covering “conventional” foods and drug products. Nutraceuticals are governed by DSHEA.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) created a regulatory framework for dietary supplements that included provisions establishing current good manufacturing procedures, mechanisms for pre-market safety notifications for new ingredients, and a mechanism for establishing claims used in product labeling. According to DSHEA, it is the manufacturer’s responsibility to ensure that a nutraceutical is safe before it is marketed.
FDA is authorized to take action against any unsafe product after it reaches the market. Manufacturers have to make sure that the information on the product label is truthful and not misleading, but they are not obliged to register their products with the FDA nor get FDA approval before producing or selling nutraceuticals.
Nutraceuticals are clearly not drugs, but active substances that will potentiate, antagonize, or otherwise modify any physiological or metabolic function.
On the other hand a nutraceutical is evidently a food component that maintains, supports, and normalizes any physiologic or metabolic function, but one that also potentiates, antagonize, or otherwise modify physiologic or metabolic functions.
Dietary supplements are not substitutes for proper nutrient dense meals and do not represent diet.
The most important aspect to supplements is their safety and here is an example of probiotics requirements:
Scientifically valid names for the genus and species should be used on the label and that the organisms should be identified below the species level to the strain.
The number of viable microorganisms per serving.
Properties of the organism that are dependent on the fermentation medium and growth conditions.
Phylogenetically related microbes that are pathogens that produce mammalian toxins.
The ability of the Life Microbial dietary ingredients to persist in the gastrointestinal tract.
The resistance of the Life Microbial dietary ingredients to clinically important antibiotics with special attention given to any transferable genetic elements encoding antibiotic resistance genes.
The incredible potency of herbs, roots, extracted foods requires for us to be rather vigilant about the safety of our supplements and pay attention to labels, presence of governmental certification, like DIN (Drug Identification Number) number for USA and NPN (Natural Product Number) for Canada.
If any of you are interested in Health Canada Food and Drugs act, please contact me and I will be more than happy to forward you the copy of the document.
One of the greatest physicians, Paracelsus states:
“The art of healing comes from nature, not from the physician. Therefore the physician must start from nature, with an open mind. Attributed to Phillip von Hohenheim (aka Paracelsus), 1493–1541.”
I cannot wait to hear your thoughts.
1. The American Journal of Medicine (2005) 118, 1087-1093 International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 2, Issue 3, 2010
2. Dietary Supplements: A Framework for Evaluating Safety
3. Committee on the Framework for Evaluating the Safety of the Dietary Supplements, National Research Council This PDF is available from the National Academies Press at: http://www.nap.edu/catalog/10882.html
4. Indian Journal of Pharmacology 2003; 35: 363-372
5. International Journal of Pharmacy and Pharmaceutical Sciences
ISSN- 0975-1491 Vol 2, Issue 3, 2010
6. Drug Information Journal, volume 43, pp 71-85, 2009
7. TOXICOLOGICAL SCIENCES 123(2), 333–348 (2011)
8. Safety assessment of probiotics for human use. Gut Microbes 1, 1–22.
9. http://www.hc-sc.gc.ca/ Health Canada