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07 Aug 2018


These days, due to a busy and stressful lifestyle, people have erratic dietary habits and are more prone to diseases. A balanced diet is the best medicine for primary prevention of disease. Many dietary supplements are now being used as prevention and treatment of chronic diseases. The nutraceutical market in India has boomed in recent years at about US $ 2 Billion in 2010.[1] The term nutraceutics was coined by Dr. Stephen DeFelice, founder and chairman of the Foundation for Innovation in Medicine (FIM), Cranford, New Jersey. According to Dr. Stephen, the term nutraceutics is defined as a product that is extracted from food which is used for medicinal purpose in prevention and treatment of chronic diseases. [1]

Many nutritional supplements, antioxidants, vitamins and minerals are used in the management of diseases like cardiovascular diseases, parkinsonism, obesity, cancer, diabetes and allergy. Most commonly consumed products are fish oil, glucosamine, pre/probiotics, melatonin, coenzyme Q10, cranberry, ginseng, ginkona, green tea extracts. Fish oil contains unsaturated omega–3 fatty acids which improve heart function and vision. Anthocyclidine, flavones, flavonones like components are extracted from tea, citrus fruits, v egetables, soya beans and have been proven in reducing the risk of cancer from their antioxidant free radical scavenging activity. Yogurt contains lactobacillus that maintains gastrointestinal health. Insoluble fibers from wheat bran reduce risk of breast and colon cancer.

Nutravigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement or medical food”.
Nutravigilance is required due to…

  • Lack of premarketing data and product information for dietary product like shelf life and stability
  • Health care professionals generally unaware about side effects of dietary supplements
  • If any adverse effect occurs with product use, it can be explained by a number of concomitant products, and causality relationship between the adverse event and product cannot be explained
  • Many manufacturers take raw material from other companies that increases the chances of contamination
  • Currently, no stringent regulations available for nutraceutics

One study failed to prove the beneficial antioxidant effects of high dose minerals in patients who had previous history of myocardial infarction. In that trial, a total of 124 subjects, out of 1708, experienced serious adverse drug reactions.[2] Another published article showed no role of vitamin E and A in the prevention of lung cancer. Incidence of cancer was more in patients taking vitamin A compared to control population. [3] FDA in collaboration with the center for food safety and nutrition (CFSAN) conducted a study from 1-Jan-2006 to 31-Dec-2006 by diverting calls from California poison centre regarding nutraceutical products.[4] A total of 275 complaints were received during that year with 8 patients hospitalized and 3 out of the 8 patients required hospitalization in intensive care unit (ICU). [4] Rhabdomyolysis has also been reported due to concomitant administration of herbs and minerals with drugs. In 2 cases of bleeding with NSAIDs due to concomitant administration with ginkona (mild epistaxis occurred) and fish oil (post spinal surgical hemorrhage) have also been reported. [4] 100 adverse events reports have been reported with folic acid from January 2004 to December 2013 at FARES (FDA adverse event reporting system). Among all reports, shortness of breath is higher with reporting odds ratio (ROR) of 1.56 than all other adverse events.[5]
More Examples:

In 2008, more than 200 cases of selenium poisoning had occurred due to multivitamin tablets. First case of acute hepatitis had been observed in May 2013 by FDA.[5] From May 2013 to Feb 2014, total 97 cases have been reported with Oxyelite pro. [6] It takes almost one year to prove Oxyelite pro’s dangerous effect on the liver. Out of 97, 47 patients required hospitalization and 3 patients underwent liver transplant surgery while one patient died due to acute hepatitis.[6] Many dietary products are nephrotoxic causing toxicity by immune mediated nephrotoxicity, nephrolithiasis (caffine, calcium supplement, cabbage, spinach), rhabdomyolysis (cascara sargada, comfry, DHEA, green tea, kava turmeric).

Adulterants and contaminants with NSAIDS known for anti-inflammatory properties cause vasoconstriction with interstitial nephritis, renal injury and renal failure. FDA has issued warning against hydrocutproducts (Garcinia cambogia) by one company due to serious liver injury reports which was widely used as a weight-loss supplement.
Regulation says…

“The manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States (referred as the ‘responsible person’) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement”.[7]

In Canada, nutrient supplements are regulated by food and drug regulations (FDRs). [7] As far as India is concerned, Indian law does not signify any legal status to nutraceutics. In EU, the European Food Safety Authority (EFSA) look after legislation and regulation related to food supplements.[7]

As far as regulations are concerned, nutraceutics haven’t been properly regulated till now. But for safe guarding the customer’s safety, proactive reporting of adverse drug events is paramount. Nutravigilance will play a crucial role by preventing potential uncertain infliction of nutrient supplements. The harm can be reduced by obeying good manufacturing practices during production of the nutrient supplements and reporting adverse events in concern of patients’ safety when therapeutic decisions are made. Data generated by reports will help in effective communication between health care professionals and people and educate everyone to interpret the fruitfulness and risk of food supplements that they consume.

  1. Global Nutraceutical Industry: Investing in Healthy Living, FROST & SULLIVAN, FICCI.
  2. Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805.
  3. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study Group. N Engl J Med. 1994 Apr 14;330(15):1029-35.
  4. Haller C, Kearney T, Bent S, Ko R, Benowitz N, Olson K. Dietary supplement adverse events: report of a one-year poison center surveillance project. J Med Toxicol. 2008 Jun;4(2):84-92.
  5. http://www.usada.org/substances/supplement-411/realize-safety-issues-exist/selenium-overdose-multivitamin/
  6. Chatham-Stephens K, Taylor E, Chang A, Peterson A, Daniel J, Martin C, Deuster P, Noe R, Kieszak S, Schier J, Klontz K, Lewis L. Hepatotoxicity associated with weight loss or sports dietary supplements, including OxyELITE Pro™ – UnitedStates, 2013. Drug Test Anal. 2016 Jul 1.
  7. Abdel-Rahman A, Anyangwe N, Carlacci L, Casper S, Danam RP, Enongene E, Erives G, Fabricant D, Gudi R, Hilmas CJ, Hines F, Howard P, Levy D, Lin Y, Moore RJ, Pfeiler E, Thurmond TS, Turujman S, Walker NJ. The safety and regulation of natural products used as foods and food ingredients. Toxicol Sci. 2011 Oct; 123(2):333-48.

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