Protecting Consumers in the Wake of the U.S. Dietary Supplement Health and Education Act
Foote, Jerald C., Journal of Allied Health
The Dietary Supplement Health and Education Act of 1994 has given allied health professionals the responsibility of assisting consumers with the use of dietary supplements. Problematic dietary supplements have been marketed and consumed, often for many years, before interventions by the Food and Drug Administration, and the clinical evaluation of these products takes pharmacologic and toxicologic skills that may be beyond the basic competency skills of some allied health professionals. Allied health professionals are in a position to make a stand regarding dietary supplements and their clinical application, but to do so they may need to complement their pharmacologic and toxicologic skills accordingly. J Allied Health 2007; 36:57-60.
MORE THAN A DECADE has passed since the implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation gave the United States a new legal category for the thousands of products sold as dietary supplements. It may also have, albeit unknowingly, given allied health professionals the responsibility of assisting consumers with the use of dietary supplements. An example is seen in the consumer education materials produced by the Food and Drug Administration (FDA), which encourage consumers to "check with your health care provider before taking a supplement."1
However, a clinical evaluation of many of the products can be difficult, because the DSHEA contained no provisions regarding FDA approval before marketing, thus allowing dietary supplements to be sold without prior proof of safety or efficacy.2 A legal analysis of DSHEA stated, "This new law reverses 45 years of increased FDA regulation of health related products prior to marketing."3 The dietary supplement industry is now responsible for the premarket safety evaluation of these products. This regulatory situation appears to place consumers at risk,4 and recent FDA actions demonstrate this predicament.
* In March 2004, manufacturers of the dietary supplement androstenedione were given an FDA warning to stop distributing the product.5 Androstenedione is an androgenic/anabolic steroid that had been sold as a dietary supplement since shortly after the introduction of the DSHEA.6 Interestingly, new legislation, apart from the DSHEA, was introduced in 2005 to help control the sale of androgenic/anabolic steroids sold as dietary supplements.7
* In February 2004, the FDA announced it would ban the sale of dietary supplements containing ephedrine alkaloids.8 Dietary supplements containing ephedrine alkaloids have been associated with a variety of adverse events, including psychiatric illness, heart attack, stroke, seizure, and death.9,10 These products were sold before the DSHEA, yet their use became widespread after introduction of the DSHEA.8 Unfortunately, a recent court ruling casts doubt on the ability of the DSHEA to keep ephedra products off the market.11
* In 2002, the FDA issued a consumer advisory regarding the use of dietary supplements containing kava (Piper methysticum).11 Kava consumption has been associated with severe hepatic toxicity, including 11 documented cases of liver failure and subsequent liver transplantation.13 Unfortunately, these toxicity reports occurred at least 1 year before the FDA advisory, and kava products are still being manufactured and sold today.14
* In 2001, the FDA issued an alert for herbal products containing aristolochic acid.15 The toxicity of this compound was well established. For more than a decade, adverse event reports have been appearing in the literature describing the carcinogenic and nephrotoxic potential of medicinal herbs containing aristolochic acid.16 More than 100 cases of rapidly progressing nephropathy have been followed up, with approximately one half of the patients developing advanced end-stage renal disease or undergoing renal transplantation.15,17 As with kava, products containing aristolochic acid are still available to consumers. …