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Regulation of herbs remains
inconsistent in the U.S. today. In 1994, Congress passed the Dietary Supplement
Health and Education Act (DSHEA). This law defines dietary supplements
as plant extracts, enzymes, vitamins, and hormonal products that are available
to the consumer without prescription. (6) Currently, there are no Food
and Drug Administration (FDA) regulations that are specific to dietary
supplements that establish a minimum standard of practice for manufacturing
dietary supplements. At present, the manufacturer is responsible for establishing
its own manufacturing practice guidelines to ensure that the dietary supplements
it produces are safe and contain the ingredients listed on the label.
Some manufacturers report
that they follow the Good Manufacturing
Practices (GMPs). GMPs are a variety of practices that ensure quality
such as raw materials quality assurance; standards for cleanliness and
safety; and in-house testing. GMPs are a more immediate and consistent
way to control quality since they provide continual measures of quality
that can uncover problems and fluctuations as they occur. Industry GMP
standards are usually subject to an independent outside audit for compliance.
Although a coalition of industry trade associations developed adraft version
of GMPs, they are not currently enforced. The National Nutritional Foods
Association (NNFA) however developed a new GMP that they deem to be effective
and appropriate. The NNFA GMP Certification Program went into effect in
1999. All NNFA supplier members are required to comply with NNFA's GMP
standards to receive the NNFA GMP seal in product literature and on labels.
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