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" ... The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts. Thus, the social media post misbrands DICLEGIS within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. . . These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated. ... "