Letter: Response to concerns on injectable Vitamin C and other injectable nutrients
Dear Concerned Consumer,
Thank you for your e-mail expressing concerns about FDA’s December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
Unlike oral vitamin C—which could be a dietary supplement— these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market.
Since FDA announced its Unapproved Drugs Initiative in June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval requirements for safety and efficacy.
The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been manufactured under sub-standard conditions, may contain too much or too little (if any) active ingredients, and may not have necessary labeling information and warnings.
FDA's drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
Again, we thank you for your input and hope that we were able to address your concerns.
The U.S. Food and Drug Administration