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July 9, 2012

The Consequences of Ineffective Regulation of Dietary Supplements

Author Affiliations

Author Affiliations: Departments of Medicine and Immunology, Baylor College of Medicine, Houston, Texas (Dr Marcus); Departments of Pharmacological Sciences and Medicine, School of Medicine, Stony Brook University, Stony Brook, New York (Dr Grollman).

Arch Intern Med. 2012;172(13):1035-1036. doi:10.1001/archinternmed.2012.2687

Prior to enactment of the Dietary Supplement Health and Education Act (DSHEA)1 in 1994, the regulatory category of dietary supplements included substances used to treat nutritional deficiencies, such as vitamins and minerals. The DSHEA expanded that category to include botanicals and other traditional medicinal products, thereby excluding these products from effective regulation by the US Food and Drug Administration (FDA).

Under DSHEA, manufacturers of dietary supplements are not required to provide premarketing evidence of safety or efficacy or, prior to 2007, to report adverse events. After 1994, sales of supplements rose rapidly, and in 2007, consumers spent $14.8 billion out of pocket for nonvitamin, nonmineral products such as herbals.2 Increased consumption of supplements was accompanied by reports of serious adverse events and adulteration of dietary supplements by prescription drugs and heavy metals.3

It is important for internists to understand the growing health problems caused by nonvitamin, nonmineral dietary supplements and the need to take action to protect the public.

Limitations in fda oversight

A report by the Government Accountability Office (GAO)4 examined how the FDA has responded to information about serious adverse events and its ability to identify and act on concerns about the safety of dietary supplements and to educate consumers about this problem. Between January and October 2008, the FDA received 596 reports of serious adverse events and 352 voluntary reports of moderate or mild adverse events. However, the FDA believes that adverse events are significantly underreported and estimates that the annual number of all adverse events is 50 000.4

The report noted the magnitude of the regulatory problem: the number of dietary supplements on the market rose from 4000 in 1994 to approximately 75 000 in 2008. Even when the agency identifies an unsafe product, it lacks authority to mandate its removal from the market because it must meet the very high legal requirement to demonstrate “significant or unreasonable” risk. That is why it took the FDA more than 10 years to remove from the market ephedra-containing herbal weight-loss products that had caused hundreds of deaths and thousands of adverse events.

An article by Cohen5 in this issue of the Archives describes a recent danger resulting from inadequate regulation. Dietary supplements containing 1,3-dimethylamylamine (DMAA), an amphetamine derivative, are legally sold in the United States. Severe adverse effects associated with DMAA include seizures and death, and it is banned in other countries. As explained by Cohen, it remains on the market owing to a loophole in the regulations allowing for products that are known to be naturally found botanicals, despite the fact that this claim is based on a single flawed study.

In addition, the GAO report noted that that the labeling of dietary supplements often is inadequate and that consumers are poorly informed about the nature and regulation of these products.4 Surveys revealed that most consumers are unaware that health claims for dietary supplements are not approved by the FDA.6 Moreover, the term dietary supplements confuses consumers concerning the medicinal nature of botanicals and other nonvitamin, nonmineral products and conceals their potential for causing serious adverse events.

Deceptive marketing

A second GAO report7 examined whether deceptive or questionable marketing practices were being used by vendors of dietary supplements and whether popular herbals were contaminated with harmful substances. Investigators also examined advertising for products sold online, and, posing as elderly customers, they asked sales staff of retail stores about health benefits of herbal supplements and their potential for interactions with over-the-counter and prescription drugs.

The investigation revealed that websites frequently made unsound and illegal claims that a dietary supplement cured or prevented serious diseases. Investigators posing as customers were informed by sales staff at retail outlets that they could take supplements instead of prescription medicines.


The FDA recently issued a warning to consumers about the dangers of adulterated dietary supplements, and FDA commissioner, Margaret Hamburg, MD,8 sent a letter regarding the problem to supplement manufacturers. She noted that the FDA has issued consumer warnings about nearly 300 products and remarked that “These tainted products can cause serious adverse events, including strokes, organ failure and death.”8

More effective regulation

Claims for the efficacy of botanical products made by manufacturers and advocates of complementary and alternative medicine are based on their long history of use and an unscientific distinction between “natural” and synthetic medications rather than on sound scientific evidence. Rigorous controlled trials of popular herbals supported by the National Institutes of Health and other independent sources of funding have found most botanical supplements to be ineffective.

The FDA recently issued a draft of new guidance9 to help the agency evaluate the safety of new ingredients of dietary supplements, a proposal that is vigorously opposed by the supplement industry. Acting through their professional societies, internists should strongly support the new guidelines, and they should urge Congress to revise DSHEA to give the FDA the authority required to effectively regulate dietary supplements. In particular, the FDA should have authority to mandate immediate withdrawal of dangerous supplements from the market. In addition, Congress should provide the FDA with the personnel and resources needed to protect the public.

The European Union (EU) has taken a more active role than the United States to ensure the safety and quality of herbal medicines.10 The Traditional Herbal Medicinal Products Directive10 of 2004 established a regulatory process requiring herbal medicinal products to obtain authorization for marketing in the EU. The authorization process requires evidence of safety and scientific support for health claims.

Consumer education

Dietary supplements are generally self-prescribed, but consumers are unable to make truly informed decisions about their use. Most information on supplements readily available in the media and on the internet is misleading: it overstates their efficacy and minimizes their potential toxic effects. For example, the PDR for Herbal Medicines11 resembles the Physicians' Desk Reference12 for prescription and over-the-counter drugs. However, the latter volume contains FDA-approved information about efficacy and potential adverse events, whereas the former contains only promotional material provided by manufacturers.

Physicians should provide guidance to patients about the use of dietary supplements. Unfortunately, physicians' knowledge of this subject often is limited13 because, in part, education about dietary supplements in many academic institutions is provided by advocates of complementary and alternative medicine in integrative medicine programs. The poor quality of integrative curricula concerning dietary supplements and other alternative therapies was reviewed recently.14

In summary, the consequences of DSHEA for consumers include the expenditure of tens of billions of dollars annually on ineffective and potentially dangerous dietary supplements. Internists and other health care professionals have paid insufficient attention to problems that may affect the 18% of the population that uses nonvitamin, nonmineral supplements.2

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Article Information

Correspondence: Dr Marcus, Department of Medicine, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030 (dmarcus@bcm.tmc.edu).

Financial Disclosure: None reported.

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