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Sombra warning letter

This article was originally published in The Tan Sheet

Executive Summary

Sombra Natural Pain Relieving Gel to "treat aches, pain, swelling, inflammation, soreness of muscles and joints caused by sports injuries, stiffness, sprains and arthritis" is a "new drug" because FDA has no information proving it is generally recognized as safe and effective, an Aug. 4 FDA warning letter to the company says. Sombra was sent a previous warning letter July 14 for making unsubstantiated natural claims and not meeting Good Manufacturing Practice standards (1"The Tan Sheet" Aug. 16, p. 10). After receiving the first letter, the company requested an extension for replying. FDA granted the extension in its Aug. 4 letter, allowing Sombra to respond to deviations to GMPs by Aug. 30
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