Posted September 17, 2013

Seller of Omega-3 and Joint Supplements Warned for Manufacturing Violations and Drug Claims

On August 29, 2013, the FDA issued a warning letter to Y.S. Health Corp., following a facility inspection which found the company's products, including HiBee Heart'n Brain Ultimate Omega-3, Arth 2000+ For Joint Flexibility & Pain Relief, Your HiBee Royal 1500, HiBee Rocky Mountains Bee Propolis 500mg and ROCKY HEALTH Mega Albumin 1000 to be adulterated because they were packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to make and keep written procedures for the responsibility of quality control operations, to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement (specific to labeling and packaging operations) and failure to establish written procedures to fulfill the requirements related to product complaints.

In addition, statements made about HiBee Heart'n Brain Ultimate Omega-3 and Arth 2000+ For Joint Flexibility & Pain Relief capsules on the Y.S. Health's website were found to be drug claims.

HiBee Heart'n Brain Ultimate Omega-3 was promoted for inflammation, arthritis, heart disease and cancer with statements such as "Research shows that omega-3 fatty acids reduce inflammation and may help lower the risk of chronic diseases such as heart disease, cancer and arthritis," and "A key component of the omega-3 EPA... inhibit blood clotting and prevent cardiovascular disease."

(See's Review of Fish Oil and Omega-3 Fatty Acid Supplements for tests of related products.)

Arth 2000+ For Joint Flexibility & Pain Relief capsules contains Kre-Alkalyn, a form of creatine, glucosamine, white willow bark and Boswellia serrata extract. It was promoted for the treatment of arthritis with statements such as "Reduces Pain... Helps Inflammation... Improves mobility."

(See's Reviews of Creatine Supplements and Glucosamine, Chondroitin and MSM Supplements for Joint Health for tests of related products.)

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