Posted October 17, 2012

Herbal Supplement Company Warned For Manufacturing Violations and Drug Claims

On October 2, 2012, the FDA issued a warning letter to Amazing Herbs Nutraceuticals following a facility inspection which found violations of Current Good Manufacturing Practices (CGMPs) for dietary supplements. These violations cause the company’s products to be adulterated because they were prepared, packed, or held under conditions which do not meet regulations for the manufacturing of dietary supplements.

Additionally, a review of the company’s websites, product literature and books found statements made about two dietary supplement ingredients used in Amazing Herb products to be drug claims.

Amazing Herbs products containing bitter melon were promoted for the treatment of diabetes, viruses, malaria, cold, flu and psoriasis. For example, the label for Amazing Herbs GlyMordica Bitter Melon supplement states the product is an “all-natural sugar-diabetes support supplement.”

Products containing black seed, or Nigella sativa, were promoted for the treatment of asthma, polio, hypertension and cardiovascular disorders, AIDS and cancer. The company’s book, Black Seed: Nature’s Miracle Remedy states, “Black Seed heals every disease except for death.”

Learn more about Bitter Melon and conditions such as Asthma, AIDS, Psoriasis and Diabetes in ConsumerLab.com’s Encyclopedia of Natural Products.

For more information about this warning letter, use the link below.