Posted April 16, 2014

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

On March 21, 2014, the FDA issued a warning letter to Aloe Man International Corp., following a facility inspection which found the company's products, GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator 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 conduct at least one appropriate test or examination to verify the identity of a component of a dietary ingredient and failure to prepare and follow a written master manufacturing record for each unique dietary supplement formulation.

In addition, statements made on the company's website about GAP Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator were found to be drug claims. 

GAP Pills contain garlic, aloe and parsley. They were promoted with statements such as, "Our GAP Pills is one of the best blood cleaners on the market. GAP Pills helps the body to cleanse the blood. We found that when you cleanse the blood, you can: Lower the blood pressure, Lower the sugar level, Lower the cholesterol levels and get good circulation." 

GAP Liquid was promoted with statements such as "The GAP Liquid is one of the best blood cleansers on the market and, as you know, when you clean your blood you can lower the Blood Pressure, lower the Cholesterol, lower the Sugar Level.

(See ConsumerLab.com's Reviews of Garlic Supplements and Aloe Supplements for tests of related products.)

The Body Healer contains vitamins A, B, C, D, calcium, potassium, magnesium, manganese and iron. It was promoted with statements such as "[C]an be put on the skin, and can be dropped in the eyes, ears, or nostrils to help the body to heal itself." 

(See ConsumerLab.com's reviews of Vitamin A Supplements, B Vitamin Supplements, Vitamin C Supplements, Calcium Supplements, Magnesium Supplements and Iron Supplements for tests of related products.)

The Big C was promoted with statements such as "[H]elps to get rid of fluid and swelling in the brain." 

Super Cleanser was promoted with statements such as "[E]limination of inflammation... supports the body's own ability to fight pain, and clear congestion, obstruction, and accumulation." 

Maximum Desire was promoted with statements such as "[F]ight off... impotence.

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

SOC contains "an abundance of herbs that provide large amounts of organic potassium chloride." It was promoted with statements such "It is very important to have enough potassium chloride present in the blood to keep fibrin... in the blood... If not, the fibrin can leave the blood... and can cause such things as fibroids, fibrocystic breast, sarcoidosis, fibromyalgia, etc.

High Thyroid Regulator and Low Thyroid Regulator were promoted with statements such as "[S]upports the body in its ability to regulate an overactive thyroid." 

The company's Dr. Johnson's Formula-C, Dr. Johnson's Body Healer, and The Aloe Man's Immuno Force were also found to be misbranded because the labels failed to contain information required by federal regulations. 

See Related Warnings:

Seller of Aloe and Vitamin C Supplements Warned for Manufacturing Violations

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