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Posted June 5, 2020

Seller of CBD, Sleep Aids, and Cold & Flu Products Warned for Manufacturing Violations

On April 28, 2020, the FDA issued a warning letter to The Dragontree Apothecary LLC, which found the company's Sleep Support, Anxiety Relief, Cold & Flu Relief, and Inflammation Relief 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 the required specifications for quality control of the dietary supplement and failure to prepare and follow a written master manufacturing record for each dietary supplement to ensure uniformity of the finished batch from batch to batch, as required by federal regulations.

In addition, the products Cold & Flu Relief, Inflammation Relief, Anxiety Relief, Sleep Support, Muscle Melt Liniment, Muscle Melt Balm, Muscle Melt Patch, CBD Headache Relief, CBD Sleep Support, and CBD Muscle Melt Balm on the company's website were found to be misbranded because they do not contain adequate directions for intended use. 

See's CBD & Hemp Extract Supplements, Lotions, and Balms Review for tests of related products.

Also see our answers to the questions Which supplements can help me sleep? and Do any supplements help prevent or treat a cold?

See related recalls and warnings:

FDA Warns Seller of CBD Lotions, Patches, Tinctures and Pet Products

Seller of Cold and Flu Supplements, "SuperFood" & More Warned by FDA

FDA Warns Seller of Magnesium and CBD

Maker of Cough and Sleep "Remedies" Warned for Drug Claims

Maker of Energy, Weight Loss, Sleep and Vitamin D Supplements Warned for Manufacturing Violations

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