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Posted November 11, 2014

Seller of Sexual, Muscle Enhancement Supplements Warned for Manufacturing Violations and Drug Claims

On August 26, 2014, the FDA issued a warning letter to GE Pharma LLC following a facility inspection which found the company's products, including Fire Burn, Fire Storm, Creatine, Amino Fire, Nitric Fire, Jet Fire, Oxy Fire, HGH, Cissus, Hydro shield, Performa-Test, Raspberry Ketones, Fire Drol, BCAA 1500, Crea Fuse, and Liquid Fire, 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 identify personnel to be responsible for quality control operations, and failure to establish and follow written procedures for packaging and labeling operations.

In addition, statements made on the company's website about Performa Test were found to be drug claims.

Performa Test was promoted for sexual enhancement with statements such as "[R]aise total and free testosterone levels" and " [H]elps blood sugar stabilization [sic], boosting libido."

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

Fire Burn, Fire Storm, Amino Fire, Jet Fire, Oxy Fire, Raspberry Ketones, HGH, Fire Drol, BCAA 1500 Cissus, and Liquid Fire products were also found to be misbranded because the labels failed to provide information required by federal regulations.

(See ConsumerLab.com's Reviews of Weight Loss Supplements, Muscle Enhancing Supplements, and see the Review Article on HGH Supplements for more information about this ingredient.)

See Related Warnings:

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

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

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below.