FDA finally issues cGMP guidance for Health Supplements

After many months of discussion FDA Issues Dietary Supplements Final Rule has been issued (Friday 22 June 2007). This tightens the loop hole used by some lower quality manufacturers. Raising the quality bar to a minimally acceptable level without undue cost is strongly supported. For 80% of manufacturers this has no ramification as they already follow cGMP. Read more about it here:  

The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

Read more at www.fda.org where you will also find the complete 800page guidance document

David Seckman, executive director and CEO of the Natural Products Association said:

We’ve waited nearly 13 years for this important regulation and are anxious to thoroughly review it and let members know exactly what it will mean to them…. With recent concerns raised about the safety of food ingredients, implementation of this regulation will help to bolster consumer confidence and keep standards high throughout the industry.

MyHealthMyWorld and all at Natural Health Formula Co-op agree.

 

22 June 2007 | Uncategorized | Comments