XanGo Brochures Draw FDA Warning Letter For Unsubstantiated Claims
This article was originally published in The Tan Sheet
Executive Summary
An FDA Warning Letter citing unapproved new drug claims for XanGo Mangosteen juice that XanGo said were made by a third party underscores the agency's position on the responsibility supplement manufacturers assume for unsubstantiated label statements
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FDA on labeling
Under the Food, Drug & Cosmetic Act "'labeling' is not limited to labels on the immediate containers for your products," FDA reminds Osceola, Wisc.-based supplement marketer NeuroScience. Claims in brochures on weight control, attention deficit hyperactivity disorder and depression position the firm's products as unapproved new drugs, FDA says in an Oct. 11 letter. Claims cited by the agency include, "neurotransmitter imbalances can trigger ADHD" and "if an imbalance is detected, the technical staff at NeuroScience works with your healthcare provider to develop a Targeted Amino Acid Therapy protocol to address the imbalance." FDA sent a letter to Xango Sept. 20 regarding claims made in third-party brochures for XanGo mangosteen juice (1"The Tan Sheet" Oct. 9, 2006, p. 12)...
FDA on labeling
Under the Food, Drug & Cosmetic Act "'labeling' is not limited to labels on the immediate containers for your products," FDA reminds Osceola, Wisc.-based supplement marketer NeuroScience. Claims in brochures on weight control, attention deficit hyperactivity disorder and depression position the firm's products as unapproved new drugs, FDA says in an Oct. 11 letter. Claims cited by the agency include, "neurotransmitter imbalances can trigger ADHD" and "if an imbalance is detected, the technical staff at NeuroScience works with your healthcare provider to develop a Targeted Amino Acid Therapy protocol to address the imbalance." FDA sent a letter to Xango Sept. 20 regarding claims made in third-party brochures for XanGo mangosteen juice (1"The Tan Sheet" Oct. 9, 2006, p. 12)...
FDA on labeling
Under the Food, Drug & Cosmetic Act "'labeling' is not limited to labels on the immediate containers for your products," FDA reminds Osceola, Wisc.-based supplement marketer NeuroScience. Claims in brochures on weight control, attention deficit hyperactivity disorder and depression position the firm's products as unapproved new drugs, FDA says in an Oct. 11 letter. Claims cited by the agency include, "neurotransmitter imbalances can trigger ADHD" and "if an imbalance is detected, the technical staff at NeuroScience works with your healthcare provider to develop a Targeted Amino Acid Therapy protocol to address the imbalance." FDA sent a letter to Xango Sept. 20 regarding claims made in third-party brochures for XanGo mangosteen juice (1"The Tan Sheet" Oct. 9, 2006, p. 12)...