Posted January 16, 2016

Seller of Liver, Lung Support Supplements Warned for Drug Claims

On January 4, 2016, the FDA issued a warning letter to Tibetan Herbal Balance, Inc., following a facility inspection which found the company's products, including  Liver Assist, Lung Support and Respibalance to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish specifications to sufficiently assure that products received for packaging or labeling as a dietary supplement were adequately identified and consistent with the purchase order, and failure to maintain records of any material review and disposition decision on a returned dietary supplement , as required by federal regulations.

In addition, testimonials about these products on the company's website were found to be drug claims. For example, Lung Support was promoted with statements such as "My son with COPD was greatly improved with your Lung Support, no longer on OXYGEN. Thank you " and  Respibalance was promoted with statements such as "I just wanted to tell you that your product is great! I ordered the Respibalance and I have not needed my inhalers now for the past month. I am able to sleep great and no longer wheeze all night!"  

See Related Warnings:

Maker of Vitamin K, Vitamin A & More Warned for Manufacturing Violations, Drug Claims

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below