Dietary supplement is one of the fast growing product in the market. According to the 1994 US dietary supplement health and education act (DSHEA), “Dietary supplement” is defined as “Food”. A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement a diet. Therefore, stringent regulation by the regulatory agency is deemed unnecessary (USP, 2009). Thus, concluding that dietary supplements are safe, is easily undebatable or accepted by many. ”Food” is necessary for body function, yet scientists agreed “dietary supplements” does not completely fulfill all the nutritional facts in food (Kurtzweil, 1998). Moreover, if in any account, all food, and its by-products are safe, it is still dangerous to assume that there is no correlation between food and diseases. The fact is not all food is safe. Some food or its by-products produce allergens that can cause adverse events. In fact, scientists have established lots of food-disease correlations. For instance, cancer society linked red-meat consumption with some colorectal cancer (Varki, 2008). Red meat contains N-glycolylneuraminic acid (Neu5GC), a known carcinogenic compound. On the other hand, there are several crop plants that contain toxic compounds. Cassava (Manihot esculenta), a popular African/South America food crop contains Cyanide which can cause death or paralysis, and soy products, also produces allergen. Onion and garlic may cause kidney failure or destruction of red blood cells when ingested by pets (Littlehampton Vet. Clinic. 2011).

Many have asked, can dietary supplement’s limited regulations likely lead to a slow and progressive health disaster? For now, the answer is not conclusive because there are several facts that are missing from dietary supplement’s safety insert. Regulatory agency do not require clinical trials or efficacy/safety trial before any dietary supplement enters the market. Thus, in many cases, there are no data assessment for either the synergetic or antagonistic effects of most dietary product (USP, 2009). Furthermore, the possibility of iatrogenic effects of dietary supplement cannot fully be assessed without controlled trials. Lack of efficacy and safety evaluation for most dietary supplements makes it difficult in quantifying dietary supplement’s potency or safety concerns. Consequently, lack of substantial scientific evidence undermines the danger a dietary supplement may pose.

In 2010, some Fish oil supplements were withdrawn from the market because they contain polychlorinated biphenyls (PCB), a known carcinogen and compound linked to birth defects (Hardy, 2011). In 2008, USA today reported that 600 people had adverse events from dietary supplement (Perez, 2008). Another observational study conducted by Palmer, E., et.al suggested that out of 1466 dietary supplement complaints, 53% or 784 complaints had an adverse event symptoms (Palmer, Haller, Mckenney, et.al. 2003). Furthermore, they indicated that 489 (62%) of those that had symptoms, showed 50% certainty that the adverse effect came directly from dietary supplement (Palmer, Haller, Mckenney, et.al. 2003). Hence, without a broader clinical study including dissolution and disassociation tests, adverse events associated with dietary supplements are mistaken as a minor problem. Obviously, Palmer, E., et.al did not think the effects are minor as they concluded, “Dietary supplements are associated with adverse events that include all levels of severity, organ systems, and age groups. Associations between adverse events and ingredients are difficult to verify if a product has more than one ingredient and because of incomplete information systems. Research into hazards and risks of dietary supplements should be a priority.” (Palmer, Haller, Mckenney, et.al. 2003). One the other hand, a study conducted by Haller, et. al., indicated that most adverse events associated with some dietary supplement are minor events. However, they strongly suggested that active surveillance is still necessary to oversee and facilitate regulation of dietary supplements (Haller, Kearney, Bent, et.al. 2008).

Many consumers take dietary supplements without informed knowledge of any potential health hazard from the product. In many cases, a dietary supplement contain many ingredients than drugs. In addition, dietary supplements tend to suggest or infer to unproven claims, a recipe for a potential public health disaster. If not all the majority of the supplement carry some type of unproven claims, which many believes, the claim is meant to draw people in to use the product. For instance, calcium-containing supplement usually phrase a suggested claim in reducing osteoporosis, a claim that only a regulatory agency-approved medicinal product should make (Kurzweil, 1998). Another instance of suggestive claim is with vitamins containing a high dose of folic acid for the reduction of risk of neural tube defect-affected pregnancy (Kurzweil, 1998). In addition, Vitamin C effects on scurvy prevention or treatment is one of the proven link between dietary supplement and disease related claims (Kurzweil, 1998). Hence, public health welfare may be better protected by initiating conditional clinical study on safety/efficacy of dietary supplements.

References

Haller, C., Kearney,T., Bent, S., et.al. (2008). Dietary supplement adverse events: report of a one-year poison center surveillance project. J Med Toxicol.4 (2):84-92. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18570167.

Hampton T. (2007). Postmarket “pharmacovigilance” program on alert for adverse events from drugs. JAMA. 298(8), 851–852. Retrieved from http://jama.ama-assn.org.ezp.waldenulibrary.org/cgi/reprint/298/8/851?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Postmarket+%22pharmacovigilance %22+program+on+alert+for+ad verse+events+from+drug.

Hardy, L. (2011).  List of Toxic Ingredients Used in Vitamin Supplements.  Retrieved from http://www.livestrong.com/article/500223-list-of-toxic-ingredients-used-in-vitamin-supplements/.

Kurtzweil, P. (1998).  An FDA guide to dietary supplements. FDA Consumer, 32(5), 28–33. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search .ebscohost.com/login.aspx?direct=true&db=a9h&AN=1081895&site=ehost-live&scope=site.

Littlehampton Vet. Clinic. (2011). COMMON TOXIC FOODS. Retrieved from http://www.littlehamptonvet.com/#/toxic-foodproducts/4549656610.

Mahoney, M. R., & Sargent, D. J. (2007, January 20). Adverse-event rates: Journals versus databases. Lancet, 369(9557), 171–172. Retrieved from            http://ezp.waldenulibrary.org/login?url=http://proquest.umi.com.ezp.waldenulibrary.org/ pqdweb?did=1203632841&sid=1&Fmt=4&clientId=70192&RQT=309&VName=PQD.

Palmer, E., Haller, C., Mckenney, E., et.al. (2003). Adverse events associated with dietary supplements: an observational study.  Lancet,361(9352):101-6.  Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/12531576.

Perez, A. (2008). Dietary supplements cause 600 ‘adverse events’. USATODAY. Retrieved from http://www.usatoday.com/news/health/2008-09-22-supplements-adverse-eventN.htm.

Strom, B. (2006). How the US drug safety system should be changed. JAMA, 295(17), 2072–2075. Retrieved from http://jama.ama-assn.org.ezp.waldenulibrary.org      /cgi/reprint/295/17/2072?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=How+the+US+drug+safety+system+should+be+changed&searchid=1&FIRSTINDE  X=0&resour

USP. (2009). White Paper: Access to Good Quality Dietary Supplement. Retrieved from http://www.usp.org/sites/default/files/usp_pdf/EN/members/dietarySupp lements.pdf.

Varki, A. (2008). How Eating Red Meat Can Spur Cancer Progression: New Mechanism Identified. Sciencedaily.com. Retrieved from http://www.sciencedaily.com/relea ses/2008/11/081113181428.htm.