In Brief: Soberup warning letter
This article was originally published in The Tan Sheet
Executive Summary
Soberup warning letter: Grand Junction, Colo.-based C&G Marketing and Manufacturing receives FDA warning letter Nov. 5 stating that the name and claims for the sobriety aid establish the product as an unapproved drug. Claims made in promotional fliers include: "Soberup...helps to detoxify alcohol from the system, which can help reduce its effects!" The product is subject to the final rule for overindulgence products, which says that no ingredient is safe and effective for use in an OTC drug either as a sobriety aid or to minimize or prevent inebriation, the warning letter notes. FDA requests that C&G immediately stop distribution of Soberup and notify the agency of the steps taken to correct the violations...
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Soberup warning letter: Grand Junction, Colo.-based C&G Marketing and Manufacturing receives FDA warning letter Nov. 5 stating that the name and claims for the sobriety aid establish the product as an unapproved drug. Claims made in promotional fliers include: "Soberup...helps to detoxify alcohol from the system, which can help reduce its effects!" The product is subject to the final rule for overindulgence products, which says that no ingredient is safe and effective for use in an OTC drug either as a sobriety aid or to minimize or prevent inebriation, the warning letter notes. FDA requests that C&G immediately stop distribution of Soberup and notify the agency of the steps taken to correct the violations.... |