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Shen Min Hair Regrowth Claims Targeted In FDA Warning Letter

This article was originally published in The Tan Sheet

Executive Summary

Biotech Corp.' s Shen Min Activator with Minoxidil and Shen Min Topical solution are new drugs due to their intended use for hair growth and hair loss prevention, FDA says in a July 27 warning letter to the company.

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Sombra warning letter

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

Sombra warning letter

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

Sombra warning letter

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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