The American Society of Health-System Pharmacists (ASHP) believes that the widespread, indiscriminate use of dietary supplements presents substantial risks to public health and that pharmacists have an opportunity and a professional responsibility to reduce those risks. ASHP recognizes that patients may choose to use legally available dietary supplements, but believes that the decision to use substances that may be pharmacologically active should always be based on reliable information about their safety and efficacy. The current regulatory framework governing dietary supplements does not provide consumers or health care providers with sufficient information on safety and efficacy to make informed decisions. Furthermore, standards for product quality are currently inadequate. ASHP recognizes the concerns raised by the dietary supplement industry regarding regulating dietary supplements as nonprescription drugs because of the industry’s inability to patent product ingredients. Still, ASHP urges Congress to amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) to require that the Food and Drug Administration (FDA) develop a regulatory scheme to ensure that dietary supplements are safe and effective. ASHP believes that dietary supplements, at a minimum, should (1) receive FDA approval for evidence of safety and efficacy, (2) meet manufacturing standards for identity, strength, quality, purity, packaging, and labeling, and (3) undergo mandatory postmarketing reporting of adverse events, including drug interactions.
ASHP strongly encourages in vitro and clinical studies of interactions between dietary supplements and medications. Because of the demonstrated risk of these interactions, ASHP discourages the concurrent use of dietary supplements and drug therapy, especially those therapies for which failure may have irreversible consequences (e.g., immunosuppressive therapy, cancer chemotherapy, treatment for human immunodeficiency virus infection, anticoagulation therapy, and hormonal contraceptive therapy).
ASHP believes that the criteria used to evaluate dietary supplements for inclusion in health-system formularies should be as rigorous as those established for nonprescription drugs and that the self-administered use of dietary supplements during a health-system stay may increase risks to patients and liabilities to health care professionals and institutions.
ASHP urges pharmacists and other health care practitioners to integrate awareness of dietary supplement use into everyday practice and encourages pharmacists to increase efforts to prevent interactions between dietary supplements and drugs. ASHP also supports the education of pharmacists and other health care practitioners in the taxonomy, formulation, pharmacology, and pharmacokinetics of dietary supplements and believes that such education should be required in college of pharmacy curricula.
Dietary supplements are defined in DSHEA as products “intended to supplement the diet” that contain vitamins, minerals, herbs or other botanicals, amino acids; “a dietary substance for use by man to supplement the diet by increasing the total daily intake”; or “a concentrate, metabolite, constituent, extract, or combinations of these ingredients.”1
Evidence of variability in dietary supplement content2–8 has spurred efforts to standardize products. Current federal regulations regarding the manufacture of dietary supplements are not adequate.9 Some manufacturers voluntarily follow good manufacturing practices (GMPs) devised by their own trade groups (e.g., the National Nutritional Foods Association GMP Certification Program10), and the U.S. Pharmacopeia (USP) has created voluntary standards for a handful of dietary supplements.11 Manufacturers that wish to carry the “USP approved” seal on their product labels have to subject their products to testing by USP. The creation of these voluntary programs reflects a widespread concern, even on the part of dietary supplement manufacturers, that production processes must be regulated. Although FDA has had the authority to establish dietary supplement GMPs for almost a decade, it issued its first proposed rule on the topic in 2003. 12
DSHEA does not require FDA to review evidence of the efficacy or safety of dietary supplements, so manufacturers have no burden to prove that their products are effective or safe. Although dietary supplement labeling cannot claim activity in the treatment of a specific disease or condition, claims that suggest an effect on the “structure or function of the body” are allowed.1 For example, dietary supplements containing echinacea can be labeled as supporting immune health (as a “function”) but cannot be labeled as preventing or ameliorating colds (treating a disease). Regardless of this distinction between function and treatment, consumers are bombarded by the lay press (and even some scientific literature) with what can only be described as specific-disease indications for dietary supplements (e.g., glucosamine for osteoarthritis, black cohosh for menopausal symptoms, and St. John’s wort for depression).
The health claims allowed in dietary supplement labeling by current interpretation of DSHEA create further confusion for consumers. FDA’s attempt to hold these health claims to the same scientific standard required for conventional foods was struck down in Pearson v. Shalala, so FDA must permit dietary supplement labels to carry “qualified” health claims based on equivocal scientific evidence.13
Although DSHEA does require that dietary supplements be safe, it does not require prospective testing to ensure safety. To remove a product from the market, FDA must prove that the product is unsafe. Under DSHEA, some dietary supplements that were banned from the U.S. market because of concerns about their safety have been allowed to return (e.g., sassafras tea, dehydroepiandrosterone). Demonstrably unsafe products have made their way onto the market, and fatal adverse reactions have been reported.14,15
Establishing the safety record of dietary supplements has been complicated by the lack of systematically collected data about their adverse reactions. The MedWatch system has been used to a limited extent to report adverse events related to dietary supplement use, but, nine years after the passage of DSHEA, FDA is still developing an adverse-reaction-reporting system for dietary supplements. Despite the limited data, however, the number of case reports of interactions between dietary supplements and medications is growing.16–21 The safety of dietary supplements for special populations (e.g., children, pregnant women, people with impaired organ or immunologic function) has also not been demonstrated.
Dangers to Public Health
It has been estimated that 40% of the U.S. population uses dietary supplements often and that almost twice as many have used at least 1 of the estimated 29,000 dietary supplements on the market.22 Out-of-pocket expenditures on dietary supplements total approximately $18 billion annually.23 Such widespread and indiscriminate use of dietary supplements presents five dangers to the public health:
- Some dietary supplements are inherently unsafe when ingested orally (e.g., chaparral, ephedra, comfrey, tiractricol, aristolochic acid, pennyroyal).24–28
- Lax regulation of dietary supplement manufacturing presents the risk of contamination or adulteration with harmful substances, including carcinogens,29–32 and of dangerous variability in active ingredient content among products.2–8
- The use of dietary supplements may compromise, delay, or supplant treatment with therapies of proven efficacy.16–21,25
- Dietary supplements may present dangers to special populations (e.g., children, pregnant women, patients undergoing surgery, patients with impaired organ or immunologic function).
- Spending on dietary supplements represents an enormous health-related expenditure of unsubstantiated value.33
Since the mid-19th century, the federal government has exercised its responsibility to protect Americans from hazardous or adulterated foods and medicines. ASHP believes that, with the passage and implementation of DSHEA, the federal government has abandoned its duty to create a regulatory scheme for dietary supplements that adequately protects the health of consumers. Under DSHEA, consumers and health care practitioners are not provided with the information they need to use dietary supplements safely. To reduce the dangers posed by the current regulatory framework, Congress should amend DSHEA to
- Require that dietary supplements undergo FDA approval for evidence of safety and efficacy,
- Mandate FDA-approved dietary supplement labeling that describes safe use in a clear, standardized format, including the potential for interaction with medications and cautions for special populations,
- Require FDA to promulgate and enforce GMPs for dietary supplements,
- Require that dietary supplements meet FDA-established standards for identity, strength, purity, and quality, and
- Empower FDA to establish and maintain an adverse-event-reporting system specifically for dietary supplements, and require dietary supplement manufacturers to report suspected adverse reactions to FDA.