FDA regulations for the Dietary Supplements industry now require cGMP

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 August 24, 2007. To minimize disruption to the industry, the FDA is employing a phase-in plan. Companies with more than 500 employees must be compliant by June 2008, companies with fewer than 500 but more than 20 employees must be compliant by June 2009, and companies with fewer than 20 employees must be compliant by June 2010.

Sources:

FDA Backgrounder:
www.cfsan.fda.gov/~dms/dscgmps7.html

FDA FactSheet:
www.cfsan.fda.gov/~dms/dscgmps6.html

FDA Press Release:

www.fda.gov/bbs/topics/news/2007/new01657.html