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US FDA Title 21 CFR PART 111 -- Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding operations for
Dietary Supplements Pocket Guide
In June
2007, the FDA issued the Dietary Supplement Current Good
Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111. In
essence, the final rule requires that the proper controls be in
place for dietary supplements during manufacturing, packaging,
labeling, and holding operations. The move was in response to
concerns about substandard dietary supplement manufacturing
practices, as well as mislabeling practices.
The 21 CFR 111 ruling addresses the quality of the manufacturing
processes for dietary supplements and the accurate listing of
supplement ingredients. It does not limit consumers' access to
dietary supplements; nor does it address the safety of the dietary
supplement's ingredients, or their effects on health, when proper
manufacturing techniques are used. The rule applies to all domestic
and foreign companies that manufacture, package, label or hold
dietary supplements, including those involved with testing, quality
control, and dietary supplement distribution in the U.S.
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