Posted February 13, 2014

Maker of Cholesterol and Workout Supplements Warned For Manufacturing Violations, Drug Claims and Unapproved Ingredient

On January 31, 2014, the FDA issued a warning letter to Exclusive Supplements Inc. following a facility inspection which found the company's products, including BioRhythm Olio, BioRhythm ReGenerate, BioRhythm Androbolix, BioRhythm Androbolix 300 and Whole Gains Mango, are 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 product specifications for the identity, purity, strength, and composition of finished dietary supplements and failure to prepare a written Master Manufacturing Record related to packaging and labeling operations.

In addition, statements made about BioRhythm Olio and BioRhythm ReGenerate on the company's website were found to be drug claims.

BioRhythm Olio contains vitamin E, olive oil, conjugated linoleic acid, alpha-lipoic acid, omega-3 fatty acids DHA and EPA, linoleic acid, GLA, and oleic acid. It was promoted for weight loss and lowering cholesterol with statements such as, "Supports reduction of "bad" cholesterol," and "Research indicates a diet that includes olive oil yields less overall disease and lower mortality rates."

(See's Reviews of Vitamin E Supplements, Alpha-Lipoic Acid Supplements, ALA and GLA Supplements, Omega-3 Fatty Acid Supplements and Cholesterol-Lowering Supplements for tests of related products.)

BioRhythm ReGenerate contains bovine colostrum, Mucuna pruriens, Cissus quadrangularis, puncturevine, and 20-hydroxy-ecdysone. It was promoted to increase lean muscle, decrease fat and improve energy with statements such as, "Cissus quadrangularis ... has already proven to be an excellent healing aid by significantly reducing the average recovery time in major injuries as well as reducing the pain associated with minor tears or inflammation."

BioRhythm Androbolix contains Tribulus terrestris, protodioscine, saponins, 6,7-dyhydroxybergomottin (DHB) and 4-etioallocholen-3,6,17-trione, an unapproved new dietary ingredient. It was promoted as a muscle-enhancer and testosterone booster.

(See's Reviews of Muscle-Enhancing Supplements and Sexual Enhancer Supplements for tests of related products.)

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