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Posted January 13, 2018

Seller of Depression, Prostate Supplements & More Warned for Manufacturing Violations, Drug Claims

On August 21, 2017, the FDA issued a warning letter to Irmo-Vita, LLC, following a facility inspection which found that several of the company's products, including Hysta-Min, Man-Affirm, Phung-EX, and Bacto- EX 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 specifications for the identity of components that are used to manufacture a dietary supplement, and failure to establish product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplements to ensure the quality of the dietary supplement, as required by federal regulations.

Several of the company's products were also found to be misbranded because the labels did not include certain required information. For example, the label for Bacto-EX did not include a serving size, the number of servings per container, or a statement identifying the product as a "dietary supplement". 

In addition, certain claims on the Irmo-Vita website and product labels were found to be drug claims. For example, the Kardi-Air label states "Beneficial for depression ...erectile dysfunction." 

(See ConsumerLab.com's Review of Sexual Enhancer Supplements for tests of related products. Also see the answers to the following questions:

Which Supplements Help With Depression and Anxiety? >>

Which Supplements Help With Erectile Dysfunction? >>

The label for Pro-Prosta states "... Helps body's own ability to remove foreign materials from the prostate." 

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

See related warnings:

Seller of BrainAlert Warned for Manufacturing Violations, Drug Claims

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

Seller of Meal Replacement, Protein Drinks, Cranberry and More Warned for Manufacturing Violations

To read the full warning letter, use the link below.