US FDA DIETARY SUPPLEMENT 2007 DSHEA UPDATE
Effective June 2010, FDA completed the three phase implementation on the cGMP's Dietary Supplements rule finalization. All manufacturers and distributors must assure the raw materials used meet the requirements for:
- identity
- purity and quality
- strength
- composition of dietary supplements
- microbiological testing, to assure free from pathogenic bacterium (i.e. E coli, Salmonella etc.)
- allergen or toxins that are inherently present in the plant or animal source
cGMP compliance finalized rules include that all companies from less then 20 employees to greater 5000 employees. According to the FDA's finalized rules, violations of the regulations are violations of the law and can lead to both civil and criminal penalties.
The final rule aims to avoid wrong ingredients; too much or too little of a dietary ingredient; improper packaging; improper labeling; or contamination problems due to natural toxins, bacteria, pesticides, glass, lead, or other substances. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
MANUFACTURER RESPONSIBILITIES:
- Manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed.
- Manufacturers must make sure that product label information is truthful and not misleading.
- Manufacturers are only permitted to make certain types of claims, and may not make false or misleading claims of any kind.
- Manufacturers must abide by current Good Manufacturing Practices (cGMPs).
- Manufacturers must submit to FDA all reports that they receive of serious adverse events associated with a product that they manufacture.
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