Protecting Consumers in the Wake of the U.S. Dietary Supplement Health and Education Act

By Foote, Jerald C

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.14,18

* A similar situation has occurred with the 2001 FDA warning to manufacturers of products containing comfrey (Symphytum offidnde and related species).19 Adverse events regarding the hepatotoxic potential of comfrey have been known for decades, and the products are still available.14,20

Should the allied health professional believe that recent FDA actions are sufficient to protect consumers? As demonstrated, under the DSHEA, problematic dietary supplements have been marketed and consumed, often for many years, before FDA interventions. The DSHEA has allowed information regarding the efficacy of certain dietary supplements to be available to consumers, and certainly allied health professionals would have access to the medical literature and research related to this efficacy. Yet it is the lack of premarketing and formal postmarketing safety evaluations that contribute to the difficulty evaluating the safety and thus the overall utility of dietary supplements. The concern for the allied health professional, because practice must occur in the current regulatory environment, is how to properly protect consumers. The purpose of this report is to demonstrate to allied health professionals that if they are going to take responsibility for their patient’s safety when addressing dietary supplement use, they must possess the appropriate pharmacologie and toxicologie skills necessary to do so.

Supplement Evaluation Is Not An Easy Task

At a time when so many individuals are using dietary supplements, it is likely that the allied health professional will be asked to evaluate these products. It is also possible that a substantial number may be recommending and/or selling dietary supplements. However, the evaluation of a dietary supplement as an appropriate treatment takes pharmacologie and toxicologic skills that may be beyond the basic competency of some allied health professionals.

For example, although the term “dietary supplement” may imply that these products would in fact be part of a patient’s diet or nutrient requirements, many of the products sold as “dietary supplements” are not nutrients (in fact, none of the dietary supplements for which the FDA has issued warnings are nutrients). For the few dietary supplements that are nutrients, they are typically taken in amounts or for purposes that make them pharmacologic agents. Two common examples include the dietary supplements vanadium and yohimbe (Pausinystalia yohimbe). Vanadium is a trace metal being investigated for its possible nutritional essentiality and its role as a pharmacologie agent, especially in the treatment of diabetes.21 The pharmacologic doses used in research and dietary supplements make the clinical evaluation of vanadium difficult in light of its potential toxicity.22-24 Yohimbe is an 32-adrenergic antagonist that has been investigated as a pharmacologic drug for decades but was shown to cause rapid changes in blood pressure, psychosis, anxiety, gastric distress, insomnia, palpitations, and tachycardia and interact with prescription medications.25,26 As a “dietary supplement,” it is marketed as an aphrodisiac and aid to weight loss and exercise performance.26

A quote by the late American herbal authority Varro Tyler speaks to the use of botanical dietary supplements such as yohimbe, “It cannot be emphasized strongly enough that herbs in their medicinal sense are drugs.”27 Therefore, if many of the dietary supplements are not taken or used as nutrients, then they are being used as pharmacologic agents and their evaluation should be consistent with their use.

To properly evaluate pharmacologic agents, the allied health professional would need to have and understand the pharmacologic and toxicologic profile for each of the products. For the majority of dietary supplements, and for some allied health professionals, this could be a difficult step. In fact, for many dietary supplements, there is such a lack of credible scientific information that no practitioner could easily recommend their use. Also, even for the few dietary supplements where there is some evidence of efficacy, these products in most instances are best considered experimental treatments. The lack of adequate safety data should preclude any health professional from considering the dietary supplement part of an established treatment protocol. Experimental treatments, especially experimental pharmacologic treatments, require clinical skills and necessitate legal and ethical responsibilities that may be beyond the basic competency skills of some allied health professionals.

However, the current regulatory environment under the DSHEA almost demands that the allied health professional understand at least the safety or toxicity of dietary supplements used by their patients. Unfortunately, even this step may be a problem, because a perusal of some common herbal texts could be of little help. A 2002 comparison of selected herbal reference texts with published toxicologic reports revealed that the texts often lacked sufficient information to adequately assess safety.28 Therefore, allied health professionals who casually recommend products in which inadequate safety information is available may not be practicing evidence- based medicine.

However, if the allied health professional is conscientious about practicing within the framework of science and ethics, and practicingevidence-based medicine, then clients of these individuals can often be forewarned about potential problems. This is especially true for androstenedione, ephedrine alkaloids, comfrey, and aristolochic acid-containing herbs. Before a client’s use of these products, a thorough review of the scientific literature would reveal to the allied health professional that the risk/benefit profile make them inappropriate treatments. Thus, it is possible, although sometimes difficult, to protect clients from adverse events. However, the necessary review of the scientific literature and development of a risk/benefit profile require the allied health professional to be proactive and competent in the pharmacologic and toxicologic skills necessary to make safety decisions.

The Role of the Allied Health Professional

If allied health professionals are going to incorporate dietary supplement evaluations into their scope of practice, then product evaluations need to be based on science and evidence-based medicine. By necessity, this includes evaluating both safety and efficacy data and taking appropriate clinical measures to assure client safety. Waiting for FDA action or assuming that industry has produced a safe product will not suffice, nor will the misunderstanding that these products can be casually recommended because they can be sold with few legal implications. The allied health professional will need to be prepared to ask for and evaluate pharmacologic and toxicologic information.

An indication that some allied health professionals will need to complement their background with pharmacologic and toxicologic skills was seen in the 2000 publication entitled A Healthcare Professional’s Guide to Evaluating Dietary Supplements.29 This special report, compiled by both the American Pharmaceutical Association and the American Dietetic Association, illustrated that allied health professionals who address dietary supplement use need to take responsibility for the patient safety that accompanies it. Also, the 2004 publication Dietary Supplements : A Framework for Evaluating Safety, by the Institute of Medicine and the National Research Council, demonstrates the need for and provides some dietary supplement pharmacologic and toxicologic information.30 This publication is intended for use by the FDA and the dietary supplement industry, but the methods used to evaluate product safety will be of interest to the allied health professional. No publication, however, can be completely effective until the allied health disciplines embrace the changes needed to assure patient safety.

Allied health professionals may need to develop relevant clinical skills in dietary supplement pharmacology and toxicology. These steps may be as simple as a practitioner reading and reviewing the scientific literature and incorporating this information into practice or may involve formal changes in educational preparation, practice standards, or continuing education opportunities. In any instance, with the current regulatory environment, the process requires the allied health professional and possibly the professional organization to become proactive. Products cannot be recommended or sold by allied health professionals who lack an understanding of the implications that a loosely regulated pharmacologic agent requires. Also, it demonstrates clinical naivete to assume that poorly understood products provide an entrepreneurial business opportunity.

Having the FDA take subsequent action against products that consumers have used with the approval of any allied health professional undermines consumer confidence and puts patients at unnecessary risk. Allied health professionals are in a position to make a stand regarding dietary supplements and their clinical application, but they must not rely solely on government regulations to help determine their safety. They also should not allow the popularity of the products to keep them from making sound scientific and ethical decisions. An argument can be made that the DSHEA places consumers in a vulnerable position. Misconceptions regarding the skills necessary to evaluate these “dietary supplements” should not exacerbate the problem. Currently, there are no “scope-of-practice” limitations placed on dietary supplements by the DSHEA, and information and advice regarding these products are available from a variety of lay and professional sources. Each of the different allied health disciplines will need to determine the level of competency needed by its members to ensure consumer safety. There is no doubt that this will be influenced by each discipline’s different academic background and role in health care. However, more than a decade has passed since the introduction of the DSHEA; it is time for allied health professionals to complement their skills accordingly or make appropriate referrals. It is also time for the qualified allied health professional to understand that these individuals need to do so.

REFERENCES

1. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition: What dietary supplements are you taking? Does your health care provider know? It matters, and here’s why. December 2004. Available at: http://www.cfsan.fda.gov/~dms/ds-take.html. Accessed August 23, 2005.

2. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition: Overview of dietary supplements. January 3, 2001. Available at: http://vm.cfsan.fda.gov/-dms/ds-oview.html. Accessed August 23, 2005.

3. Bass IS, Young AL: Dietary Supplement Health and Education Act: a legislative history and analysis. Washington, DC: The Food and Drug Law Institute; 1996:p ii.

4. Fontanarosa PB, Rennie D, DeAngelis CD: The need for regulation of dietary supplements-lessons from Ephedra. JAMA 2003; 289:1568-1570.

5. U.S. Department of Health and Human Services: HHS launches crackdown on products containing andro: FDA warns manufacturers to stop distributing such products. Press release March 11, 2004. Available at: http://www.fda.gov/bbs/topics/news/2004/ hhs_031104. html. Accessed August 23, 2005.

6. Yesalis YE: Medical, legal, and societal implications of androstenedione use JAMA 1999; 281:2043-2044.

7. Blumenthal M: President signs new law banning designer steroids dietary supplements: DHEA exempted from ban. Herbalgram 2005; 65:58-59.

8. U.S. Department of Health and Human Services, U.S. Food and Drug Administration: FDA News: FDA issues regulation prohibiting sale of dietary supplements containing ephedrine alkaloids and reiterates its advice that consumers stop using these products. February 6, 2004. Available at: http://www.fda.gov/bbs/topics/NEWS/ 2004/ NEW01021.html. Accessed August 23, 2005.

9. Bent S, Tiedt TN, Odden MC, et al: The relative safety of ephedra compared with other herbal products. Ann Intern Med 2003; 138:468-471.

10. U.S. Food and Drug Administration: Ephedra and ephedrine for weight loss and athletic performance enhancement: clinical efficacy and side effects. Evidence Report/Technology Assessment Number 76. Available at: http://www.fda.gov/bbs/topics/NEWS/ephedra/ summary.html. Accessed August 23, 2005.

11. Blonz E: Ephedra ruling exposes weakness of federal law. The San Diego Union-Tribune May 25, 2005:p E-2.

12. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition: Kava-containing dietary supplements may be associated with severe liver injury. March 25, 2002. Available at: http://www.cfsan.fda.gov/~dms/addskava.html. Accessed August 23, 2005.

13. Centers for Disease Control and Prevention: Hepatic toxicity possibly associated with kava-containing products-United States, Germany, and Switzerland, 1999-2002. Morb Mortal Wkly Rep 2002; 51(47):1065-1067.

14. Dangerous supplements: still at large. Consum Rep. 2004; 69(5):12-17.

15. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutritional Products, Labeling and Dietary Supplements: Letter to industry associations regarding safety concerns related to the use of botanical products containing aristolochic acid. April 19, 2001. Available at: http://www.cfsan.fda.gov/~dms/ds- botl4.html. Accessed March 15, 2004.

16. Kessler DA: Cancer and herbs. N Engl J Med 2000; 342:1742- 1743.

17. Nortier JL, Martinez MC, Schmeiser HH, et al: Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engi J Med 2000; 342:1686-1692.

18. Gold LS, Slone TH: Aristolochic acid, an herbal carcinogen, sold on the web after FDA alert. N Engi J Med 2003; 349:1576.

19. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition: FDA advises dietary supplement manufacturers to remove comfrey products from the market. July 6, 2001. Available at: http://www.cfsan.fda.gov/-dms/dspltr06.html. Accessed August 23, 2005.

20. Westendorf J: Pyrrolizidine alkaloids-general discussion. In: DeSmet PAGM, Keller K, Hansel R, et al (eds). Adverse Effects of Herbal Drugs. Volume 1. New York, NY: Springer-Verlag; 1992:pp 193- 206.

21. Mukherjee B, Patra B, Mahapatra S, et al: Vanadium-an element of atypical biological significance. Toxicol Lett 2004; 150:135- 143.

22. Thompson KH: Vanadium and diabetes. Bio/actors 1999; 10(1) :43-51.

23. Clarkson PM, Rawson ES: Nutritional supplements to increase muscle mass. Crit Rev Food Sci Nutr 1999; 39:317-328.

24. Fragakis AS: The Health Professional’s Guide to Popular Dietary Supplements, 2nd ed. Chicago, IL: American Dietetic Association; 2003: pp 387-392.

25. DeSmet PAGM: Yohimbe alkaloids-general discussion. In: DeSmet PAGM, Kellei K, Hansel R, et al (eds). Adverse Effects of Herbal Drags. Volume 3. New York, NY: Springer-Verlag; 1997: pp 181-205.

26. Fragakis AS: The Health Professional’s Guide to Popular Dietary Sup’ piements, 2nd ed. Chicago, IL: American Dietetic Association; 2003: pp 47-M78.

27. Tyler VA: Herbs of Choice: The Therapeutic Use of Phytomedici\nais. New York, NY: Pharmaceutical Products Press; 1994: p 1.

28. Haller CA, Anderson IB, Kim SY, et al: An evaluation of selected herbal reference texts and comparison to published reports of adverse herbal events. Adverse Drug React Toxicol Rev 2002; 21:143-150.

29. ADA/APhA Release Special Report: A Healthcare Professional’s Guide to Evaluating Dietary Supplements. Available at: http://www/ aphanet.org/news/DietSupp.html. Accessed June 1, 2004.

30. Committee on the Framework for Evaluating the Safety of Dietary Supplements, Food and Nutrition Board, Board on Life Sciences: Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press; 2004.

Jerald C. Foote, PhD, RD

Dr. Foote is Assistant Professor, Food & Human Nutrition, Human Environmental Sciences, University of Arkansas, Fayetteville, AR.

Received September 29, 2005; revision accepted March 13, 2006.

Address correspondence and reprint requests to: Jerald C. Foote, PhD, RD, Human Environmental Science, HOEC 118, Fayetteville, AR 72701. Tel 479-575-4599; fax 479-575-7171; e-mail: jcfoote@uark.edu.

Copyright Association of Schools of Allied Health Professions Spring 2007

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