Which of the following statements would most likely NOT be allowed on the label of a dietary supplement?

A. Labeling is not always reliable and herbal products should be used with caution. Herbal products are not subject to the same rigorous regulations and testing as pharmaceutical drugs. Therefore, their labeling may not always be accurate or comprehensive. Patients need to be aware of potential risks, interactions, and variations in potency associated with herbal products. Education helps patients make informed decisions and use these products safely.

B. Herbal products are approved under strict FDA regulations. This statement is false. Unlike pharmaceutical drugs, herbal products are regulated as dietary supplements in the United States and are not subject to the same level of scrutiny and approval processes by the FDA. While the FDA regulates the manufacturing and labeling of dietary supplements, including herbal products, the standards are not as strict as those for prescription or over-the-counter medications.

C. There are so few side effects, and they can be purchased without a prescription. This statement is misleading and potentially dangerous. Herbal products can indeed have side effects and interactions with medications, and their safety profiles vary widely. Additionally, the availability of herbal products without a prescription does not necessarily imply safety. Patients need education to understand potential risks and benefits associated with herbal product use.

D. The manufacturer has repeatedly demonstrated effectiveness. This statement is unsubstantiated and may not be true for all herbal products. Unlike pharmaceutical drugs, herbal products often lack extensive scientific evidence supporting their effectiveness for specific indications. While some manufacturers may conduct studies to support their products' efficacy, the evidence may be limited or inconclusive. Patients need education to critically evaluate claims of effectiveness and make informed decisions about herbal product use.

A. May improve cardiac function: This statement avoids claiming to diagnose, treat, cure, or prevent disease. It uses general language about supporting heart health, which is permissible.

B. May reduce pain and inflammation: Similar to option A, this statement avoids disease claims and uses general terms about pain and inflammation, which is allowed.

C. Helps promote a healthy immune system: This follows the same principle. It avoids disease claims and uses general language regarding the immune system.

D. Reduces blood pressure and the risk for stroke: This statement specifically mentions a disease (stroke) and claims to reduce its risk. Dietary supplement labels are not allowed to make disease claims. They can only make general claims about supporting bodily functions.