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Are drugs safer than dietary supplements?

Rebecca S. Reeves
Nutrition & Dietetics
The Food and Drug Administration (FDA) considers all new drugs to be unsafe until they are proven safe by clinical trials, and the FDA must approve any new drug before it can be legally sold in the US. The FDA approval process requires that any new drug be proven in a series of clinical trials. These studies must show "substantial evidence"  that the drug is both safe and effective for each of its intended uses.  Once the FDA approves the drug. it must be manufactured under carefully monitored conditions and packaged with complete information on the best dose and schedule.

In 1994 the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which placed them under different regulations than drugs. They are considered safe until proven otherwise.  The DSHEA says that dietary supplements cannot contain anything that may have a significant unreasonable risk of illness or injury. But manufacturers are not required to test new ingredients or supplements in clinical trials which would help find risks or potential interactions with drugs or other substances.  Dietary supplements are found unsafe only after they cause harm. This is the reverse of the way prescription and non-prescription drugs are treated.

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.