The Gary Null Blog

After our Action Alert on the FDA’s move against intravenous vitamin C, a number of rumors have sprung up. Today we want to sort through the confusion. As we reported to you last week [1], the US Food and Drug Administration recently sent a warning letter [2] to McGuff Pharmaceuticals, ordering it to stop manufacturing and distributing intravenous vitamin C. The warning letter lists several issues, but the issue of concern falls under the subheading Unapproved New Drug and Misbranding Violations. The FDA letter tells the firm, “You manufacture and market unapproved new drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§ 355(a) and 352(f)(1)] of the Act”—that is, the Federal Food, Drug, and Cosmetic Act, or FD&C.