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Posted October 24, 2012

Manufacturer of Green Tea, Vitamin E, Omega-3 and Cranberry Supplements Warned For Manufacturing Violations, Misbranding and Drug Claims

On October 16, 2012, the FDA issued a warning letter to dietary supplement manufacturer Advanced Nutritional Technology Inc., following an inspection of the company's facility which revealed violations of Current Good Manufacturing Practices (CGMPs) for manufacturing, packaging labeling and holding operations. These violations cause the dietary supplements manufactured by Advanced Nutritional Technology to be adulterated because they have been prepared, packed or held under conditions that do not meet CGMP regulations.

Several of the company's dietary supplements were also found to be misbranded or promoted as drugs.

Advanced Nutritional Technology's Co Enzyme Q10 was found to be misbranded because the label did not include a supplement facts panel, did not identify the product as a dietary supplement and did not include a company address or phone number, as required by federal regulations. In addition, statements made about the product on the company's website were found to constitute drug claims. It was promoted to treat high blood pressure, Alzheimer's disease and Parkinson's disease, and protect against heart attack and cancer.

(See's Review of CoQ10 Supplements for tests of related products.)

Ultra Diabless contains bitter melon and green tea, and was promoted for the treatment of blood sugar, glucose intolerance and for lowering LDL cholesterol.

(Another manufacturer was recently warned for making claims of blood sugar control about Bitter Melon. See's Review of Green Tea Supplements for tests of related products. )

Nutr-E-Sol contains a "unique form of vitamin E that is absorbed directly through the intestinal wall without the use of bile for emulsification," according to Advanced Nutrition's website. It was promoted for the treatment of Cystic Fibrosis, Crohn's Disease, Short Bowel Syndrome, and Biliary Cirrhosis. 

Nutr-Epo contains evening primrose oil and was promoted for the treatment of arthritis, allergies, eczema, inflammation and cardiovascular disease.

Super G contains borage oil, which the company stated was high in omega-6 fatty acids and gamma linoleic acid. It was promoted for arthritis, allergies, eczema and inflammation.

(See's reviews of Vitamin E Supplements and Black Currant, Borage, Evening Primrose, and Flaxseed Oil Supplements for tests of related products.)

Formula 3/6/9 and Super EPA 2000 contain omega-3 fatty acids and were promoted for lowering cholesterol and blood pressure and reducing the risk of heart disease and stroke. The company website also stated that omega-3's "dramatically reduce the risk of death, subsequent heart attacks, and stroke" in individuals who have had a previous heart attack.

(See's Review of Fish Oil and Omega-3 Supplements for tests of related products.)

Crangel contains cranberry extract and was promoted for the treatment of cystitis and urinary tract infections.

For more information about this warning letter, use the link below.