Dietary Supplements: How Family Physicians Can Address Safety Concerns by Working with the FDA.

The nation’s physicians rely on the U.S. Food and Drug Administration (FDA)—the first consumer health protection agency created following the Pure Food and Drug Act of 1906—to safeguard all medical products prescribed for our patients. However, the FDA continues to have only limited oversight of more than 85,000 dietary supplements of uncertain effectiveness or safety, often used by patients without their family physician’s knowledge. That is why it was troubling to hear of the death of a healthy 18-year-old Ohio student attributed to an acute cardiac arrhythmia from an unintentional overdose of caffeine.1,2 The student athlete ingested about 1 teaspoon of a powdered caffeine product to enhance exercise performance, inadvertently consuming the equivalent of more than 30 cups of strongly brewed coffee in a single dose. Members of Congress and a respected food safety group, the Center for Science in the Public Interest, have called for FDA action to ban all bulk caffeine products sold directly to patients.3,4 In December 2014, the FDA announced that it was looking into this product safety issue and working on next steps.5 Since then, it has issued warning letters to several powdered caffeine manufacturers and updated its dietary supplements web page to include information on safety concerns for powdered caffeine products.6 Caffeine is regulated by the FDA as a food additive, dietary supplement, and drug, and it remains available for sale online in formulations that are dangerous because of the inability of our patients to determine a safe dose without a measuring scale. Promoted widely for its noticeable ergogenic effect during high-intensity exercise (e.g., weight training), powdered caffeine is used by adolescent athletes in the hope of enhancing workout performance.7-9 The 100to 300-g containers sold online for $20 or less include 10 to 30 lethal doses of powdered caffeine. Your patients are likely using some type of dietary supplement, whether they tell you or not. More than one-half of U.S. adults consume a dietary supplement daily, with use growing steadily over the past decade.10 Many supplements that claim to enhance specific elements of health (e.g., stamina, sexual performance, bone joint health, mental acuity) are found to be ineffective for the purported benefit or found to be toxic, harmful, or even deadly.11,12 Few patients or physicians understand that the FDA does not have the authority under current law to approve or monitor dietary supplements in the same rigorous fashion as its postmarket surveillance of prescription drugs.13 In contrast, consider the antihypertensive medication that you prescribed today. The FDA can assure you and your patient that the drug dispensed by the pharmacy is of the quality, security, and integrity expected in the United States—safe when used as specified in the prescribing information approved by the FDA. The Dietary Supplement Health and Education Act (DSHEA) of 1994 made supplement manufacturers responsible for ensuring that their products are safe, essentially using an honor system. The supplement that your patient is taking under DSHEA is presumed to be safe and effective; manufacturers do not need FDA approval before selling their product. The FDA mainly depends on physicians and patients to recognize and report unexpected safety issues. This must occur before any steps can be taken to evaluate the safety signal, create a risk mitigation plan, warn the public of newly discovered safety concerns, and, if risk mitigation fails, remove the supplement from the market.14 Under authority recently granted by Congress, the FDA can now require dietary supplement manufacturers to report a serious adverse event when they become aware Editorials