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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted July 16, 2019
FDA Warns Seller of Magnesium and CBD
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.
Report a Problem
If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. Please select from one of these options:
Dietary Supplement or Nutritional Product Problem Report
If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused an unexpected, adverse reaction, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their Safety Reporting Portal at https://www.safetyreporting.hhs.gov.
Please complete the form below as accurately as possible. You may need to check the label on the product.
Thank you for submitting your report.
Generic Drug Problem Report
If you believe that a generic drug has not acted like the original drug, we would like to know about it. We are collecting and organizing this information and may publish it. We might test the product in the future. You may also want to report the problem to the U.S. FDA through their MedWatch program at the FDA MedWatch website.
Please complete the form below as accurately as possible. You may need to check the label on the drug.
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