Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted November 10, 2020
FDA Warns Seller of Digestive Enzymes, Nattokinase, and More
On October 27, 2020, the FDA issued a warning letter to World Nutrition, Inc. following a review of the company's website, which found statements made about some of the company's products, including Vitalzym Extra Strength, Vitalzym Systemic and Digestive Formula (Vitalzym Original Hybrid Formula), Vitalzym Cardio, Vitalzym Digest, Vitalzym Xe, Nattovita, Ketsumeisei, Probiotic 10/50 by Vitalzym, Flexera, and PuraCell to be drug claims.
For example, Vitalzym Systemic and Digestive Formula (Vitalzym Original Hybrid Formula) was promoted with statements such as "Serrapeptase, the primary systemic enzyme ingredient [in the product], is... known for its ability to control inflammation, regulate the immune system, remove excess plaque and fibrous tissues."
(See ConsumerLab's Digestive Enzyme Supplements Review for tests of related products.)
Nattovita was promoted with statements such as "This proprietary blend combines the power of nattokinase with vitamin K2, CoQ10, and B vitamins necessary for managing inflammation."
(See ConsumerLab's Nattokinase Supplements Review for tests of related products.)
In addition, these products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.
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