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Posted June 7, 2013

Seller of Red Rice Yeast With CoQ10, Respiratory Supplement And More Warned For Manufacturing Violations and Drug Claims

On February 25, 2013, the FDA issued a warning letter to Altasource, LLC, dba Meta Labs LLC, following a facility inspection which found the company's dietary supplements, including Respiratory Response, African Mango, Coffee Black Salve, Meta-Cell, Conjugated Linoleic Acid and Red Yeast Rice with CoQ-10, to be adulterated because they were were prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practices regulations for dietary supplements.

These violations include failure to make and keep written procedures for the responsibilities of the quality control operations, failure to establish laboratory control processes that are reviewed and approved by quality control personnel, and failure to prepare and follow a written master manufacturing record for each unique dietary supplement formulation.

In addition, statements made on Meta Labs' website about Respiratory Response, African Mango, Coffee Black Salve, and Meta-Cell were found to be drug claims.

Respiratory Response contains tylophora, Ophiopogon japonicas, astragalus, Codonopsis pilosula, cordyceps, bupleurum, Angelica sinensis, Chinese licorice root, long pepper, ginger, and prince ginseng. It was promoted for smoker's cough, asthma and emphysema with statements such as "Traditionally used to treat airway constriction due to asthma and other respiratory conditions."

(See's Review of Ginseng Supplements for tests of related products.)

African Mango was promoted for a variety of conditions, including high cholesterol, diabetes and diarrhea, with statements such as "highly effective in sequestering cholesterol and taking it out of your body," and "Clinical studies also support the pit of African mango as a treatment aid for obesity and elevated levels of low-density lipoprotein, or LDL cholesterol."

(See's Review Article on African Mango Supplements for more information about this ingredient and see the Review of Cholesterol-Lowering Supplements for tests of related products.)

Coffee Black Salve is a topical cream that contains coffee extract, caffeine extract, aloe vera extract, stearic acid, glycerol monostearate, dimethicone, cetly acetate, acetylated lanolin alcohol, grape fruit extract, vitamin A, vitamin D and vitamin E. It was promoted for age spots, skin blemishes and skin cancer, with statements such as "Coffee Black Salve's caffeine cancer protection occurs inside the skin cells after exposure to the ultraviolet rays."

(See's Reviews of Green Coffee Bean Extract Supplements, Vitamin A Supplements, Vitamin D Supplements and Vitamin E Supplements for tests of related products.)

Meta-Cell is a topical cream that contains glutathione and super oxide dismutase. It was promoted for repair from injuries with statements such as "A combination that can help your body repair damage caused by …radiation, disease, infections, drugs, … aging, injury, trauma, and burns? Well, Meta-Cell Cream…has been specially created by Meta Labs just for that purpose!"

(See's answer to the question, Do glutathione supplements work to prevent aging or for other conditions? for more information.)

Respiratory Response, African Mango, Conjugated Linoleic Acid and Red Yeast Rice with CoQ-10 were found to be misbranded because the labels fail to provide information required by federal regulations.

See's Reviews of Red Yeast Rice Supplements and CoQ10 Supplements for tests of related products.