Posted July 31, 2018

FDA Warns Seller of Joint Health and Cholesterol Supplements

On July 13, 2018, the FDA issued a warning letter to GC Natural, following a facility inspection which found a number of the company's products, including Red Pyrola Plus + Advanced Joint Formula Capsules, CSDP GOLD Capsules, Rejeune Optimal Kidney & Liver Support Extract balls, C. Mori Optimal Respiratory System Support Extract balls, and Evodia Extract Powder, 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 and follow written procedures for the responsibilities of the quality control operations and failure to establish specifications for dietary supplement labels.

In addition, statements made about some products on the company's website or on product labels were found to be drug claims. For example, "Red Pyrola's Main Ingredients...[are] great for inflammation in joints and chronic pain." 

(See ConsumerLab.com's Review of Joint Health Supplements for tests of related products).

A claim for CSDP GOLD Capsules states "...good for those who have a hard time with cholesterol, blood pressure, and diabetes." 

(See ConsumerLab.com's Review of Cholesterol-Lowering Supplements for tests of related products)

Rejeune Optimal Kidney & Liver Support Extract balls claimed to be "...great for Lumbar, Knee, and sexual problems." 

(See ConsumerLab.com's Review of Sexual Enhancer Supplements for tests of related products)

The products Red Pyrola Plus +, Red Pyrola, Youth Factor+ for Women, CSDP Gold, CSDP, C. Mori, Evodia Extract, Rejeune and Sinus Health were also found to be misbranded because the labels fail to identify the part of the plant from which each botanical dietary ingredient in the product is derived. 

See Related Warnings:

Seller of Apple Cider Vinegar, Joint Supplements & More Warned for Drug Claims

FDA Warns Seller of Milk Thistle, Chromium, Joint Supplements & More for Manufacturing Violations

Seller of Male Enhancement, Prostate Supplements & More Warned for Drug Claims

FDA Warns Seller of Arthritis, Blood Pressure, Diabetes Supplements For Making Drug Claims

FDA Warns Seller of Supplements for Allergies, Joint Pain, Bone Health, and More

To read the full warning letter, use the link below: