Question

Many prescription drugs are derived from natural plant products. Numerous other plant substances, including caffeine and nicotine, have effects in the human body as well. There is also a wide array of plant products, in the form of pills, powders, or teas, marketed as herbal medicines. Some people prefer taking these "natural' products to pharmaceuticals. Others use herbal supplements to boost energy, promote weight loss, strengthen the immune system, relieve stress, and more. The U.S. Federal Drug Administration, which approves pharmaceuticals, is also responsible for regulating herbal remedies. What does the label “FDA- approved” on an herbal remedy mean? How does that compare to FDA approval of a drug? The FDA website is a good place to start your research. (Note that the FDA classifies herbal remedies as dietary supplements.)

Answer 1

If the FDA approves a drug or a 'herbal remedy', it means that the agency has determined that the benefits of the product outweigh the known risks for the intended use.

Herbal supplements, also called botanicals, are a type of dietary supplement. But herbal supplements generally are not subjected to similar scientific scrutiny and are not strictly regulated like medications by FDA.

Herbal supplements fall under a category called dietary supplements. The rules for dietary supplements are as follows:

• Manufacturers may not seek FDA approval before selling dietary supplements.
• Companies can claim that their products address a nutrient deficiency, support health or are linked to body functions — if they have supporting clinical research.
• Companies aren't allowed to make a specific medical claim.
• Manufacturers must follow good manufacturing practices and meet quality standards.