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Article: Native Remedies, LLC, Boca Raton, FL, Oct. 12 (CFSAN).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
- Article from:
- Warning Letter Bulletin
- Article date:
- November 1, 2006
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Copyright informationCOPYRIGHT 2006 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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CFSAN reviewed your Native Remedies' website and determined that the products Triple Complex Diabetonic, Insulate Plus and Vizu-All Plus were being promoted for conditions that caused the products to be considered drugs.
The unsubstantiated therapeutic claims on Native Remedies' website to which the agency objected include, but were not limited to: "Use Insulate Plus regularly to: [b]alance blood sugar levels in order to reduce or remove the need for insulin or hypoglycemic medications.... [i]mprove circulation to the feet and hands which ...