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The Importance of FDA Regulation on Herbal Medicine - page 3 / 10





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that all drugs had to be proven safe and effective before being sold on the market.

Unfortunately, even after 40 years, the cost of testing herbs for medicinal value is

extremely high. A Tufts University report showed it takes an average of 12 years and

$231 million to develop a new drug (Tyler 22). Because of the high cost of proving an

herb has medicinal value, manufacturers removed labels stating any value, placing the

herb in the “food category” with no government restrictions and leaving “little on the

label except the name of the herb” (Tyler 22).

Making the situation even more difficult is the lack of a definitive volume to

determine safety, quality, purity, and uses of botanicals. For the past 30 years, the

Botanical Codex Committee of the American Society of Pharmacognosy has been trying

to produce such a volume, but has had little success due to the lack of funds (Tyler 24).

Moreover, the FDA’s regulatory power has been sharply curtailed by the Dietary

Supplement Health and Education Act of 1994. As Linda Marsa explains, this act was

passed because consumers and politicians thought the FDA was going to take away their

freedom to use vitamins. The FDA was able to get little help from Congress: “The only

concession the FDA wrestled from Congress was that supplement manufactures couldn’t

claim that a product prevents mitigates treats or cures a specific disease (then it would be

considered a drug)” (Marsa).

Another problem is that manufacturers have implied medicinal benefits without

actually stating the herb will help. One instance of an herb being sold with implied, but

not tested, medical benefits is kava root, which has unknown side effects that could be

dangerous (Kluger and Khur). Kava, a member of the pepper family, was first

discovered by Captain Cook in the Polynesian Islands in 1769. The Polynesians believed

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