Posted September 5, 2015

Maker of Multivitamin and Fish Oil Warned for Manufacturing Violations

On July 22, 2015, the FDA issued a warning letter to Westar Nutritional Corp. dba Viva Life Science, Inc., following a facility inspection which found the company's products, including Viva Kids Plus, Viva Ez Kids, B-Easy, LipoGuard, and SelGuard, to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish specifications for the identity of each component that you use in the manufacture of a dietary supplement, and to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by federal regulations.

In addition, statements on the company's website made about   LipoGuard and SelGuard , were found to be drug claims. For example, LipoGuard was promoted with statements such as "An FDA report cites the LipoGuard® study by Dr. Morcos as the only one out of 24 comparisons to actually lower LDL (bad) cholesterol in clinical test subjects...

SelGuard was promoted with statements such as " A clinical study on SelGuard has been published in the peer-reviewed journal, Anticancer Research, and the abstract was presented at the 1999 Annual Convention of the American Association of Cancer Research (AACR)."  

The FDA noted that scientific publications cited by companies in order to sell products constitute a drug claim if the citation refers to a disease.

See ConsumerLab.com's Reviews of Multivitamin and Multimineral Supplements, Fish Oil and Omega-3 Supplements and Selenium Supplements for tests of related products.

See Related Warnings:

Maker of Joint Supplement Warned for Manufacturing Violations

Maker of B-12 Energy Supplement Warned for Manufacturing Violations

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

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

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