New FDA Regulations for Dietary Supplements - Sponsored Whitepaper

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For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.

New FDA regulations for the dietary supplement industry aim to eradicate consumer concern and health risks associated with these products. Dietary supplement manufacturers and distributors are now required to follow Good Manufacturing Practices (GMPs) similar to those of the pharmaceutical industry. The FDA 21 Code of Federal Regulations (CFR) Part 111 was established to insure the identity, purity, quality, strength, and composition of dietary supplements and applies to those involved in the manufacture, packaging, labeling or holding of a dietary supplement, with the exception of retail establishments selling directly to consumers.

The federal government is taking a tiered approach to enforcement: companies with more than 500 employees were required to become compliant by June 2008; companies with 21-499 employees must become compliant before June 2009; and companies with fewer than 20 employees will need to be compliant by 2010...
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