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Posted April 17, 2018

FDA Warns Seller of Echinacea, Iron, Aloe Supplements & More for Manufacturing Violations

On March 30, 2018, the FDA issued a warning letter to Ozark Country Herbs following a facility inspection which found a number of the company's products, including Echinacea-Goldenseal, Natural Iron, and Aloe-Vera Goldenseal Salve, 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, Echinacea-Goldenseal was promoted with statements such as "May be beneficial for all viral infections, stomach disorders, inflammation, and skin disorders." 

(See ConsumerLab.com's Reviews of Echinacea Supplements and Berberine and Goldenseal Supplements for tests of related products.)

Natural Iron was promoted with statements such as "May be beneficial for anemia...digestive problems, and acne." 

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

Aloe-Vera Goldenseal Salve was promoted with statements such as "Heals and prevents infection in minor burns, cuts and wounds." 

(See ConsumerLab.com's Review of Aloe Liquids, Gels, and Supplements for tests of related products.)

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:

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

Seller of Liquid Aloe & Mineral Supplement Warned for Manufacturing Violations

Seller of Echinacea Warned Manufacturing Violations, Drug Claims

Seller of Vitamin C, Iron and Detox Supplements Warned for Violations, Drug Claims

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

To read the complete recall, use the link below.