Warning Labels

The 300 million (Siegle, 2008) dietary supplement users are unwitting participants in quite possibly the largest randomized control study regarding the safety of dietary supplements. This de facto participation is made evident by the 37 L-tryptophan users whose deaths in 1989 highlighted a dose-response relationship that resulted in the recognition of 60,000 global eosinophilia-myalgia syndrome cases (Rieber et al., 2010). This is continuously reinforced as supplement users are validating their dissatisfaction with conventional treatments, their desire to control their own health care, and agreement with the philosophy of prevention and ideas of alternative therapies (Astin, 1998) while risking exposure to chemicals, contaminants, and toxins (van Breemen et al., 2008). The rapid development, production, and distribution of dietary supplements (van Breemen et al., 2008) fuels this desire and contrasts the lengthy process of prescription drug development, manufacture, testing, and FDA review and approval and expense (USFDA, 2007) that results in conventional prescription drugs. In addition, supplement users are simultaneously confronted with over-the-counter and prescription drug recalls of Tylenol, Benadryl, Meridia, Multaq, Paxil, Propofol (USFDA, 2011) and documentation of their debilitating side-effects that misguidedly reinforces the concept of “natural” as safer. This precarious cycle is aptly illustrated by the progression of willow bark as a traditional and “natural” analgesic and antiinflammatory drug, the extraction of salicylic acid from the willow bark, and chemical synthesis into acetylsalicylic acid (aspirin). Subsequently, aspirin is implicated in case-control studies as contributing to Reye’s syndrome (Glasgow, 2006). Thus, depicting that conventional medications also carry risks associated with use and safety issues are prevalent among all types of ingestibles. The contentious issue remains as the impression that dietary supplements are safer has not been adequately dispelled. Perhaps, a more extensive warning label informing the consumer of their automatic enrollment in a supplement control study would adequately impress upon the possibility of unknown, yet potentially hazardous side-effects.



Astin, JA. (1998) Why patients use alternative medicine: Results of a national study. JAMA 279, 1548-1553.



Glasgow JF. (2006) Reye’s syndrome, the case for a causal link with aspirin. Drug Safety 29,12, 1111-1121.



Belohradsky BH. (2010) AHR activation by tryptophan—Pathogenic hallmark of Th17-mediated inflammation in eosinophilic fasciitis, eosinophilia–myalgia-syndrome and toxic oil syndrome. Immunology Letters 128, 2, 154-155.



Siegle, L. (2008, February 17). How Healthy are Dietary Supplements?. The Observer. http://observer.guardian.co.uk.


U.S. Food & Drug Administration. (2007) CDER 2007 Update: Improving Public Health Through Human Drugs. Retrieved January 19, 2010, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess

U.S. Food & Drug Administration. (2011) Enforcement Reports. Retrieved January 19, 2010 from http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm



Van Breemen, R.B., Fong, H.H., & Farnsworth, N.R. (2008) Ensuring the Safety of botanical dietary supplements. The American Journal of Clinical Nutrition 87, 2, 509S-5013S