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The Importance of FDA Regulation on Herbal Medicine - page 4 / 10





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that it had mind-altering effects, which is also the belief of many Americans. After ABC

News ran a story about kava root, Americans widely accepted this as a safe, effective

substitute for Valium, although there has not been sufficient evidence of kava’s safety or

efficiency (Kluger and Khur). The FDA has found that kava’s active ingredient is

kavalactones, which affects the limbic system or the “emotional center of the brain.”

Doctors have found that even temporary, heavy use of kava can cause yellow, flaking

skin; the long-term effects are unknown. However this fact does not slow the sale of

kava in the U.S., which is now a $3 million market (Kluger and Khur). The FDA has

allowed the sale of kava in the U.S. as long as the manufacturers promote this product as

a supplement. The manufacturers cannot cite any specific medical benefits until more

studies have been conducted (Kluger and Khur).

Along with kava root, there are many other herbs that have unknown side effects

and benefits, but consumers must blindly choose nutritional supplements because the

FDA’s authority has been strictly restricted. Appropriate labeling, consistent

manufacturing standards, and reasonable evidence of safety are rules the FDA needs to

have the authority and funding to establish. As Consumer Reports states:

Consumers have won a high level of safety for the food and drug, and a

high level of protection against misleading ads. Reputable sellers of

dietary supplements are trying to meet those same standards for safety and

honesty. We should recognize that more and more people believe

supplements are useful remedies, and ensure that they are safe and

effective. (“Alternative-Medicine”)

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