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.
Further, because McGuff was unable to show (a) that this form of vitamin C was exempt because it had been grandfathered in under the FD&C, or (b) that they were in compliance with new drug approval protocols, the FDA ordered them to discontinue manufacturing and distributing intravenous vitamin C immediately.
What we still don’t know is the extent to which FDA is targeting IV C. The acting director told ANH-USA that any other company unable to show an exemption or prove that it has taken IV C through the drug approval protocols would be subject to a similar order to cease production and distribution. What she would not tell us was when or whether they intend to move on other manufacturers and distributors. We know that FDA has a history of targeting specific products, such as estriol and natural desiccated thyroid. Sometimes they begin with one company in an effort to scare other companies into shifting business practices, and sometimes they send letters to multiple companies at once. At other times, they speak to companies behind the scenes without issuing official warning letters of public record.
The good news is that so far, it appears FDA has gone no further than this initial firm. It’s possible that FDA merely intended to test the waters with this first company, and that public reprisal via your messages has them rethinking their strategy. It’s also possible that FDA intended to target this one company alone, although we should reiterate that the language in the warning letter would apply to all other companies currently making or distributing IV C.
There is some more potentially helpful news. Injectable vitamin C is both manufactured by companies in bulk and on an individual prescription basis by compounding pharmacies. It appears that FDA may have targeted the manufacturing end of things, rather than the compounding pharmacies. Although IV C alone has not been approved as a new drug, it is a component of other drugs which have already been approved and which have USP monographs. This is important, because it means that intravenous C can arguably continue to be made by compounding pharmacies even if the FDA targets the remaining manufacturers of IV C.
It would be devastating to lose widespread access to IV C, but ANH-USA does not believe it will disappear completely, because compounding pharmacies could still make it. So it’s not time to stockpile intravenous vitamin C just yet! We must, however, remain vigilant.
ANH-USA is continuing to receive information about IV C daily. We will continue to monitor FDA’s actions, and as always, we will update you as we learn more.