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Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplement manufacturers have the responsibility to substantiate the safety of the dietary ingredients used in the manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not misleading. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. The FDA accomplishes its responsibilities through monitoring safety literature, dietary supplement adverse event reports, and product information, such as labeling, claims, package inserts, and accompanying literature.

Good Manufacturing Practices

As part of DSHEA, Congress gave the Secretary of Health and Human Services and the FDA by delegation, the express authority to issue regulations establishing current good manufacturing practice requirements (CGMPs) for dietary supplements. The FDA has issued a final rule establishing requirements for the production of dietary supplements. This rule:
  • Requires certain activities in manufacturing, packaging, labeling and holding of dietary supplements to ensure that a dietary supplement contains what it is labeled to contain and is not contaminated with harmful substances such as pesticides, heavy metals, or other impurities.
  • Requires certain activities that will ensure the identity, purity, quality, strength, and composition of dietary supplements, which is a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.
Vitamin Testing and other independent agencies test the effectiveness (potency and quality) of certain vitamins. As long as the manufacturer follows the DSHEA’s ‘good manufacturing practices’, there is no current legal requirement for formal vitamin testing.
This article was published on Monday 04 February, 2008.
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