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321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling," said FDA in their letter to Guangzhou Huli based in Chicago

This was primarily achieved through inhibition of NF-B activation, leading to decreased MLCK expression, while promoting the expression of atrexin and ZO-1 (Zhao et al., 2021)