Usana fda aproved
USANA HEALTH SCIENCES IS NOW AN FDA‐REGISTERED FACILITY USANA Meets Compliance To New Drug Standards
SALT LAKE CITY – July 11, 2011 – USANA Health Sciences, Inc. (NYSE: USNA) today announced it has obtained the U.S. Food and Drug Administration’s “Drug Establishment Registration,” allowing the company to manufacture over‐the‐counter (OTC) drugs and holding it to a standard well above what is required of a dietary supplement manufacturer. While nutritional companies in the United States are not expected to follow pharmaceutical Good Manufacturing Practices (GMPs), USANA believed it was an important, logical step to acquire government registration proving their long‐ standing commitment to producing the highest quality products. USANA manufactures over 90% of its products in‐house, including all of its tableted nutritional supplements. As an FDA‐registered facility, USANA now has the ability to manufacture OTC drugs as well. All products manufactured under this license will be subject to very rigorous FDA drug manufacturing GMP guidelines going well beyond those required to manufacture nutritional supplements. “Few companies voluntarily submit themselves to increased scrutiny, but since we operate in 15 countries including Australia, where dietary supplements are highly regulated by the Therapeutic Goods Administration (TGA), our base manufacturing standards are extremely high,” says USANA Chief Executive Officer, Dave Wentz. “So while obtaining FDA registration won’t affect our day‐to‐day operations, it will help further assure our users of the quality of our products.” For many years USANA has voluntarily modeled our production on pharmaceutical GMPs and consistently obtained third‐party certification as a way to ensure the safety and efficacy of its nutritional products. ...
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