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Posted May 10, 2013

Seller Of Sexual Enhancement and Hormonal Balance Supplements Warned For Manufacturing Violations

On April 26, 2013, the FDA issued a warning letter to Pristine Bay, L.L.C. dba Vianda, following a facility inspection which found the company's Enzyte, Ogoplex, and Avlimil Complete 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 establish finished product specifications for the identity, purity, strength, and composition of finished dietary supplements, failure to perform any quality control operations and failure to report a serious cardiovascular-related adverse event associated with Enzyte within 15 days.

The FDA describes Pristine Bay as a "distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements" released for distribution under its own name, but warns the company that "Although, your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplements it places into commerce (or causes to be placed into commerce) are not adulterated for failure to comply with dietary supplement CGMP requirements."

Enzyte contains red ginseng, ginko biloba, grape seed extract, horny goat weed, Muira puama, niacin and zinc. It was promoted for sexual enhancement.

Ogoplex contains zinc, Swedish flower pollen extract, saw palmetto berry extract, and tomato lycopene concentrate. It was also promoted for sexual enhancement.

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

Avlimil contains soy isoflavones, black cohosh root extract, sage leaf, red raspberry leaf, cayenne pepper, damiana leaf, ginger root, licorice root and valerian root. It was promoted for women's hormone balance and libido.

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

See Related Warnings:

Enzyte "Male" Supplement Found to Affect Heart

Feds Seek Millions from Seller of Enzyte Sexual Enhancement Supplement

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