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Posted April 17, 2018

Seller of Osha and Cayenne Supplements & More Warned for Manufacturing Violations

On March 21, 2018, the FDA issued a warning letter to Secret Garden of Health & Healing, LLC, following a facility inspection which found a number of the company's products, including Osha Root and Cayenne, 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, failure to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record, and failure to collect samples of each lot of packaged and labeled supplement.

In addition, certain statements made about the products on the company's website and on product labels were found to be drug claims. For example, Osha Root was promoted with statements such as "...has been used by Native Americans for eons when they had a cough or sore throat." 

Cayenne was promited with statements such as "Historically used to clean out arteries and stop bleeding." 

Several of the company's products were also found to be misbranded because their labels included drug claims, incorrect information, or were missing information required by federal regulations. 

See related recalls and warnings:

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Liquid Aloe & Mineral Supplement Warned for Manufacturing Violations

FDA Reports Prevalence of Salmonella In Retail Spices

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

To read the complete recall, use the link below.