'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, the US Food and Drug Administration recently sent a warning letter 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.
The letter goes on to specify which “unapproved new drugs” are being targeted: various formulations of injectable (intravenous) vitamin C, magnesium chloride, and B complex 100.
In our discussions with the acting director of the Compliance Branch of the FDA, ANH-USA confirmed that the FDA’s determination of intravenous vitamin C as an unapproved drug is completely unrelated to other issues raised in the warning letter. We mention this because widespread rumors are circulating that this particular firm was targeted for reasons that would not relate to other firms, and that other manufacturers of IV C would not be affected. This is simply not true. According to the acting director, the FDA has gone through an internal process whereby they determined injectable vitamin C to be an unapproved drug.'
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