FDA WARNING_LETTER - Prime Health Products - September 10, 2014

On July 29, 2015, the FDA issued a Warning Letter to Prime Health Products, Toronto, Ontario, Canada, following a website review (www.sensiblehealth.com) in June 2015 and an inspection of their dietary supplement manufacturing facility from September 8-10, 2014.

The FDA determined that numerous products, including Liver/Gallbladder Flush 4-Pack, Chinese Bitters, Gold Coin Grass, Coptis, Curcuma, Chrysanthemum, Meta Plus, Shou Wu Tea, Taheebo Tea, Kidney Tea, Plantago Seeds, Black Sesame Seeds, Boat-Fruited Sterculia Seeds, Prime Herbal Mouthwash, and Mu Shang Aluminum-Free Herbal Deodorant, are unapproved new drugs due to disease treatment/prevention claims on their website and labels. These products are not generally recognized as safe and effective for their stated uses, violating Sections 201(g)(1)(B), 201(p), 301(d), and 505(a) of the Act. Additionally, Chinese Bitters, GCG, Coptis, Curcuma, Chrysanthemum, Kidney Tea, Shou Wu Tea, Taheebo Tea, and Plantago Seeds are misbranded under Section 502(f)(1) for lacking adequate directions for layperson use.

Furthermore, Chinese Bitters, GCG