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The FDA and Herbal Supplements

• The FDA classifies herbal supplements as foods rather than medicines, which means they are not held to the same strict standards for testing, manufacturing, or labeling that apply to pharmaceutical drugs.
• Today, many supplement labels highlight how certain herbs may affect functions in the body. However, they are not allowed to claim that these products can treat, cure, or prevent specific medical conditions. This is because herbal supplements are not required to undergo clinical trials or meet the rigorous standards that prescription or over-the-counter medications must follow.
• For instance, St. John’s wort is a widely used herbal supplement often associated with mood support. A product label might state that it “helps enhance mood,” but it cannot legally claim to treat depression.
• Another key difference is that herbal supplements are not standardized in the same way as medicines. The term “standardized” may appear on labels, but its meaning can vary greatly from one manufacturer to another, making consistency across products uncertain.