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The Importance of FDA Regulation on Herbal Medicine - page 7 / 10





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Kay emphasizes the need for people to know what they are taking, how much to take, and

if it will interfere with anything else they are taking. In many cases, a plant in the genera

has been studied, “but not the specific species that are being used medicinally” (Kay


What must be done about unregulated herbal medicines? There are several steps

that must be taken. First, Dr. Varro E. Tyler, a distinguished professor of pharmacognosy

at Purdue University’s School of Pharmacy and Pharmacal Sciences, has suggested four

steps for guiding the FDA-regulation of manufacturers:

  • 1.

    Establish a legal standard for the quality and safety of herbs through a volume.

  • 2.

    Implement the proper botanical name to identify the specific plant source, which is necessary for “[p]ermitting certification of the identity and quality of an herb” (Tyler 25).

  • 3.

    Create herbal regulations proving the herb safe and effective.

  • 4.

    Eliminate herb sales to treat specific ailments if the efficiency has not been proven (Tyler 24).

Although these steps will take time, energy, and money, they are necessary to ensure

efficacy and safety for consumers. In addition to these four steps, we need to give the

FDA the power and resources to enforce herbal regulation.

In conclusion, herbal medication without regulation is very dangerous.

Consumers need to know what they are buying, proper dosages, how to prepare

medicines, and which herbal medicines will interfere with prescription drugs, foods, and

over-the-counter products. Unfortunately, as in the case of the S.E Massengill Company

of Bristol, Tennessee, back in 1937, manufacturers today have become equally

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