FDA Warning Highlights Need for Vigilance in Purity Testing

By CNCA on Jun 10 2011 | Comments | |

Chinese Medicine

A recent warning letter from the Food and Drug Administration (FDA) to a manufacturer of contaminated Ginseng supplements underscores the need for manufacturers to conduct more stringent testing to ensure that their supplements have maximum freedom from contaminants.

In the letter, the FDA reported that inspectors found ginseng supplements contaminated with the pesticides chlorpyrifos and pentachlorobenzonitriles. Chlorpyrifos disrupts the nervous system causing nausea, dizziness and confusion. Exposure to pentachlorobenzonitriles may cause skin, eye and lung irritation.

The FDA cited their no-tolerance policy for the pesticide chemical residues saying, “It is your responsibility to ensure that your establishment is in compliance with all requirements of the federal regulations. Moreover, it is your responsibility to produce safe products."

This isn’t the first time that ginseng contamination--or similar issues with other herbals-- have been reported. In 2010, the independent testing lab, Consumerlab.com reported that five out of eleven ginseng supplements selected for testing were contaminated with lead and/or pesticides or contained less ginseng than reported on their labels. Consumerlab.com reported a history of quality problems with ginseng supplements dating back to 2000.

Last year a Congressional investigation of herbal dietary supplements found that 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits.

Ginseng and many other herbal supplements may be exposed to pesticides, herbicides, and other environmental toxins prior to harvest. These contaminants have been found in domestic and imported samples at similar frequencies which dispels a common myth that domestic sources are safe. According to a 2004 FDA report, 60% of 62 imported ginseng samples were found to be contaminated compared with 57% of 79 domestic samples.

FDA regulations require manufacturers to verify the identity of raw ingredients-- in this case, that the ingredient is indeed ginseng. But the regulations do not require supplement makers to test for what shouldn’t be there unless there is a “reasonably anticipated contaminant” likely to be present. Therefore quality testing for all contaminates known to be common to any specific herbal product should be a part of all manufacturers’ quality assurance protocols. In practice, however, manufacturers can pretend that there isn’t a potential for contamination and simply not test for it.

“Far too few manufacturers go beyond the minimum of identity testing to consistently include testing for common contaminants,” said CNCA Director, Neil Reay. “CNCA uses independent labs to test all raw ingredients beyond what is required by the FDA and rejects all raw materials that do not meet our standards. And, every bottle bears a quality pledge that lists the tests performed on that product,” said Reay. The quality pledge on a bottle of CNCA ginseng reads: Independently tested for authenticity, potency, heavy metals, solvent residue, herbicide & pesticide residue, aflatoxins, stability and bacteria, yeast and mold counts.

FDA warning letters are a constant reminder that supplement users need to choose their supplement brands carefully and only after researching their quality standards and testing protocols. To learn more about how to choose the best quality supplements, review our series of Supplement Savvy articles.