FDA Finds Ginseng Product Contamination

MINNEAPOLISFDA is checking contamination levels in popular herbal supplements, which calls for extra vigilance from product manufacturers to ensure proper testing protocols are in place.

FDA recently found an American ginseng supplement from Hsu S Ginseng Enterprises was contaminated with the pesticides chlorpyrifos and pentachlorobenzonitriles, according to a warning letter FDA Minneapolis District Director Gerald J. Berg sent the company president Paul C. Hsu. FDA collected a sample during its Nov. 3 to Dec. 3, 2010, inspection, and tests revealed the product was adulterated within the meaning of the section 402(a)(2)(B) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 342(a)(2)(B). The agency said the Act holds a no-tolerance policy for the pesticide chemical residues found in the supplement.

This is of particular importance to ginseng producers, as ConsumerLab.com found five out of 11 ginseng (both American and Asian) products it tested in August 2010 were contaminated with lead and/or pesticides or contained less ginseng than expected from label claims. Read more about those test results here.

The FDA test of Hsus product was conducted on a sample (number 501236) labeled Root to Health, American Ginseng, Herbal Supplement, 500 Veggie Capsules 500 mg. each, Net Wt. 250 g. (8.82 oz.), Hsus Ginseng Enterprises Inc., P.O. Box 509, Wausau, WI 54402-0509, Lot#022109-1170, EXP:03/13."

In the warning letter, FDA put liability in the hands of Hsu, 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." Further, FDA warned failure to comply with the act may result in regulatory action, including seizure of products and/or injunction of the company.

Hsus problems didnt stop there, as FDA noted the 2010 inspection also found a number of deficiencies of cGMP (current good manufacturing practice) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111).  These include:

Finished product release specifications for ginseng encapsulated products did not include that finished products meet identity, strength, purity, composition or contamination limits per 21 CFR 111.70(e).

The companys training records did not include who was trained, training topics covered, who provided the training, course length and if training objectives were successfully met per 21 CFR 111.12(c).

Copies of the batch records for both the American Ginseng 500 Veggie Capsules Herbal Supplement and the Bee Pollen & American Ginseng 100 Capsules Herbal Supplement were not available per 21 CFR 111.610(a) and (b).

Lastly, FDA noted the expiration date placed on product labels of 500 Veggie capsules should be supported by data per 72 FR 34752 at 34856, June 25, 2007, and advised Hsus to continue to work with it customers to provide supporting data for the expiration dates placed on products.