FDA Supplemental GMP Regs: Slow Boat to China

  • by: |
  • 06/22/2007
Thirteen years in the making...GMP requirements for supplements and herbal products.

From http://www.thetansheet.com

Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.

FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.

The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."

The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.

While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.

Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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