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The Importance of FDA Regulation on Herbal Medicine - page 2 / 10





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The Importance of FDA Regulation on Herbal Medicine

In 1937, the S.E. Massengill Company of Bristol, Tennessee, marketed Elixir

Sulfanilamide, consisting of 8.8% of the drug and 72% diethylene glycol, or antifreeze.

Elixir Sulfanilamide caused 105 deaths due to acute kidney failure before its poisonous

character was recognized. SE Massangill was only one of the many corrupt drug

manufacturers in the early 1900s (Tyler 18-19). Unfortunately, the practices of the early

pharmaceutical manufactures have been adopted by present-day manufacturers of herbal

remedies and nutritional supplements.

For centuries, people have used herbs as medicine. Herbal medicine was first

recorded by the Chinese in a book called Nei Jing around 300 BCE. Since the Chinese,

many cultures have used herbal medications. In our culture, herbal medicines have made

a comeback, with the sales of last year totaling over $3.2 billion (Marsa). For the last

three years, sales have jumped 15 to 20 percent annually (Marsa). Even with sales this

high, there have been very few tests ensuring the safety and efficiency of the herbs being

sold. Manufacturers have also been known to mislead the consumer by mislabeling

herbs, like stating the family of an herb instead of its specific genus and species. Many

users assume that herbs are “natural” and, therefore safe, but buying herbal medication

has become dangerous for the unsuspecting consumer. Although many people take

pleasure in the freedom to use herbal medication without regulations, herbs need to be

regulated because some are dangerous, the doses are unknown, often the labels are

misleading, and they can interfere with prescription medications, foods, and other herbs.

Because pharmaceutical fraud was very high in the early 1900s, a situation that

hasn’t since changed, the government knew it had to act. In 1962, the government stated

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