On June 22, the U.S. Food and Drug Administration announced that it was releasing a final rule establishing requirements for current good manufacturing practices (cGMP) for dietary supplements.
The rule applies to companies involved in manufacturing, packaging, labeling, and storing dietary supplements.
The final rule requires quality control procedures, testing ingredients, and testing finished products. It also introduces recordkeeping requirements.
Manufacturers will be required to evaluate the identity, purity, strength, and composition of their dietary supplements. Any supplements that contain contaminants, or that do not contain the dietary ingredient(s) they are labeled as containing, the FDA will consider them adulterated or misbranded.
The final rule aims to:
- Ensure that dietary supplements are produced in a quality manner
- Ensure that dietary supplements do not contain impurities
- Ensure that dietary supplements are accurately labeled
- Prevent inclusion of the wrong ingredient(s)
- Prevent inclusion of too much or too little of the dietary ingredient(s)
- Prevent contamination
- Prevent improper packaging
The final cGMP will be effective
FDA Backgrounder:
www.cfsan.fda.gov/~dms/dscgmps7.html
FDA FactSheet:
www.cfsan.fda.gov/~dms/dscgmps6.html
FDA Press Release:
