Posted July 16, 2019

FDA Warns Seller of Magnesium and CBD

On July 9, 2019, the FDA issued a warning letter to Ceba-Tek, Inc. following a facility inspection which found the company's products, including its Desert Harvest Magnesium with Super-Strength Aloe Vera to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices (cGMP) for dietary supplements. 

These violations include failure to establish specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch , as required by federal regulations.

Desert Harvest Magnesium with Super-Strength Aloe Vera was found to be misbranded because the product label lacked information required by federal regulations , including the part of the aloe vera plant used in the product and contact information and/or address of the manufacturer, packer, or distributor. The product label also falsely states that Desert Harvest Magnesium with Super-Strength Aloe Vera is "100% cGMP compliant."

(See ConsumerLab.com's Reviews of Magnesium Supplements and Aloe Supplements for tests of related products.)

During its inspection, the FDA also found that the company was processing a CBD/Hemp product that was not yet labeled. The agency commented: "FDA has stated that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which CBD has been added. FDA has further stated that CBD products are outside the statutory definition of a dietary supplement. Finally, an unapproved new drug cannot be distributed or sold in interstate commerce."

See ConsumerLab.com's CBD Oils and Hemp Extracts for tests of related products. Also see our answer to the question: Is CBD oil (cannabidiol) effective and safe? Is it legal?

See related recalls and warnings:

FDA Warns Seller of Reishi, Joint Supplements, Ginseng & More for Pesticides, Other Violations

Seller of Astaxanthin, Cinnamon, Pine Bark and More Warned for Manufacturing Violations

FDA Warns Seller of Joint Health Supplements & More for Manufacturing Violations

Seller of Prostate, Immune Supplements & More Warned for Manufacturing Violations

Seller of Liquid Aloe & Mineral Supplement Warned for Manufacturing Violations

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

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