FDA Issues Supplement Guidance

The U.S. Food and Drug Administration (FDA) launched a new initiative to educate consumers about the risks and benefits of dietary supplements. The initiative, named “Supplement Your Knowledge,” was released June 2 with the intent to “educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements.”

According to the FDA, more than 50% of Americans use dietary supplements. These supplements can be recommended by a medical professional, or are taken of the consumer’s own volition. However, the agency stated that a comprehensive understanding of the risks and benefits of dietary supplements is still needed.

Most consumers do not know that, unlike all food and drugs that come into the U.S., the FDA has little authority over the manufacture, distribution, advertising, or sale of nutritional supplements. In fact, the FDA is not even allowed to preemptively screen nutritional supplements for effectiveness or to ensure that the supplement’s ingredients list is accurate. For this reason, nutritional supplements are required to display the disclaimer, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The FDA’s Supplement Your Knowledge fact sheet acknowledges the agency’s lack of power over supplement companies. Under the subheading, “How are Dietary Supplements Regulated?,” the agency states, “FDA does not have the authority to approve dietary supplements or their labeling before they are sold to the public.” Furthermore, the FDA states that they may not even know about new supplements since companies “can often introduce a dietary supplement to the market without notifying FDA.”

Rather than preemptively analyzing dietary supplements to ensure they are safe before they enter the U.S. marketplace as they do with all food, drugs, and medical devices, the FDA instead states that the “FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace.”

The agency is not powerless to act against supplement companies. In the event that a supplement is found to be unsafe, the FDA can take steps to either correct the issue or remove the supplement from the market. One downside of this method is that it does require consumers to already be suffering ill effects from a supplement before the agency has the jurisdiction to investigate.

The FDA also warned consumers about adverse effects that can occur while taking supplements. According to the agency, dietary supplements “may contain ingredients that can have strong effects in the body” and could result in a negative reaction. The FDA stated that these kinds of reactions are especially likely if consumers:

  • Take more of a supplement than is recommended by the packaging.
  • Combine two or more different supplements.
  • Combine prescription or over-the-counter medications with supplement use.
  • Take supplements as an alternative to a prescribed medication.

In the event that a supplement is involved in an adverse event, the FDA recommends reporting the event via the agency’s Safety Reporting Portal.

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