FDA WARNING_LETTER - Prestige Chinese Teas Company, Inc. - April 09, 2013

On December 31, 2013, the FDA issued a Warning Letter to Prestige Chinese Teas Company, Inc. following an inspection from April 2-9, 2013. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The company's websites (www.pcteas.com and www.teastohealth.com) were found to promote products like Ginseng Lin-Chi TuoCha tea, Premier LIN-CHI Plus capsules, E-TEA Herbal Drink, E-TEA Capsules, and Herbal Eczema Capsules with therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B) of the Act. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating section 505(a). Furthermore, these drugs are misbranded under section 502(f)(1) due to inadequate directions for layperson use.

Additionally, several dietary supplement products, including Dieters’ Herbal Drink X-Strength, Dieters’ Herbal Drink Regular Strength, Dieters’ Herbal Drink capsules, E-Tea Herbal Drink tea bags, E-Tea Herbal Drink capsules, and Premiere LIN-CHI