Posted August 30, 2012

FDA Warns of Medical Claims Made For Numerous Chinese Herbal Products

On August 15, 2012, the FDA warned Dragon Herbs that promotional statements made on the company’s website constitute drug claims for twenty herbal products, including CardioPro 2000, Cordyceps, Duanwood Reishi, Gynostemma, Ginseng and Astragalus Combination, Dang Gui and Gelatin, Sweet Relief, Remove Stagnation, Bupleurum and Dragon Bone, Amolo Tea, Activated Minor Bupleurum, Standardized Scute, Salacia, Shou Wu Formulations, Ant Essence Capsules, Ten Complete Supertonic, Super Adaptogen, Endocrine Health, Supreme Protector, and Super Pill. The FDA also warned that these products were misbranded due to inadequate directions for use.

CardioPro 2000 contains the herb Gynostemma pentaphyllum, and was promoted for boosting the immune system and cardiovascular benefits, including lowering LDL cholesterol. Cordyceps is a mushroom used in traditional Chinese medicine and was promoted as having anti-tumor activity and regulating blood pressure. Duanwood Reishi contains the mushroom Ganoderma lucidum and was promoted for the treatment and prevention of angina, lowering LDL cholesterol, and “attacking” cancer cells. Gynostemma, or Gynostemma pentaphyllum, is a traditional Chinese herb and was promoted for the treatment of inflammation, high cholesterol, obesity and arthritis.

Dragon Herbs promoted its Ginseng and Astragalus Combination for restoring the immune system in chronic disease.

(Learn more about Cordyceps and Astragalus in the Encyclopedia of Natural Products and see ConsumerLab.com’s Review of Ginseng Supplements for tests of products with similar ingredients.)

The company’s Dang Gui and Gelatin formula contains the herb Angelica sinensis and was promoted for the treatment of bleeding and miscarriage.

(See ConsumerLab.com’s articles on Endometriosis and Dysmenorrhea to learn more about the use of some of these herbs for related conditions.)

Sweet Relief was promoted for treating blood sugar imbalance. Remove Stagnation contains a blend of herbs including Ligusticum chuanxiong rhizome, white peony root, dong quai root and achyranthes root and was promoted for the treatment of poor circulation. Bupleurum and Dragon Bone contains cinnamon and ginger along with the common Chinese herb bupleurum root and “dragon bone,” which is powdered, fossilized animal bone. The formula was promoted for the treatment of drug and alcohol withdrawal symptoms.

Amolo Tea contains the Asian fruit Phyllanthus emblica and was promoted for the treatment of “light” hypertension and blood sugar levels in diabetics.

In addition, Dragon Herbs recommended in its product catalog a number of “immune-boosting formulas” for HIV positive people, including Shou Wu Formulations, Ant Essence Capsules, Ginseng and Astragalus, Ten Complete SuperTonic, Super Adaptogen, Endocrine Health, Supreme Protector and Super Pill.

Learn more about many of the herbs listed above in ConsumerLab.com’s Encyclopedia of Natural Products article on Traditional Chinese Herbal Medicine. For more details regarding the FDA’s warning letter, use the link below.