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March 24, 2008
PUYALLUP, Wash.Many dietary supplements that claim to benefit men seeking to enhance erectile function and performance also claim they are safe and effective; however, they are often adulterated with approved pharmaceutical ingredients (API) putting the patient at risk by possibly interacting with certain medications and dangerously lower their blood pressure. Portland, Ore.-based Life Span Labs, LLC, claimed to perform quality assurance procedures and conduct preclinical toxicology studies for its product 112 Degrees, a product for men containing five vitamins, four minerals, one amino acid and five botanicals. Before marketing the product, Life Span Labs performed preclinical toxicology research, 10 studies in total; an evaluation of these studies determined that each study had been performed in a Good Laboratory Practices (GLP)- and FDA-compliant laboratory. They also conducted numerous quality assurance assays and test for ingredient and formulations, a total of 12, based on production records of both the manufacturer and distributor. A safety assessment found Life Span Labs has an active quality assurance and analytical program in place with the ability to discover the kinds of adulteration of male sexual performance supplements that triggers FDA investigation. The tests also concluded the toxicology studies and standard operation procedure performed on 112 Degrees made it unlikely that there is any API contamination.
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