The U.S. Food and Drug Administration (FDA) has injectable vitamin C on its radar, according to a recent Action Alert from the Alliance for Natural Health-USA (ANH), an organization that works to protect consumer access to natural health products. ANH’s announcement that the FDA recently informed a pharmacy that it could no longer manufacture or distribute injectable vitamin C is creating reaction and protest on the Internet.
Intravenous vitamin C, often combined with other vitamins, is used by many naturopaths and other integrative health practitioners to treat conditions such as chronic fatigue syndrome, mononucleosis and the flu.
According to the group’s Action Alert, the FDA’s recent action is “is wiping out one of the best potential treatments for these conditions.”
“There are so many dangerous drugs out there that the FDA should be focusing on [instead of injectable vitamin C],” says ANH Executive Director Gretchen DuBeau. In its Alert, DuBeau’s group calls for readers to contact the FDA to “stop the war” on intravenous vitamin C.
Legal experts say FDA is simply enforcing the law
Industry experts are quick to point out that the FDA is simply enforcing the law.
“The FDA's reasoning is likely that IV vitamin C is not an approved drug for the intended uses of treating flu and cancer,” says Susan Brienza, an attorney with Ryley, Carlock and Applewhite. “Dietary supplements must be ingested, so an IV product would necessarily be a drug.”
All unapproved new drugs are banned by the FDA, so the agency’s mandate that a pharmacy discontinue manufacturing and distributing injectable vitamin C “should not come as a surprise,” Brienza adds.
Is the FDA’s reported crackdown on injectable vitamin C indicative of the agency’s current or future stance toward dietary supplements?
“Injectable anything, whether it’s vitamin C, interferon, et cetera, makes it, per the letter of the law, a drug, so I don’t think this has anything to do with the natural products industry,” says Daniel Fabricant, vice president of global government and scientific affairs for the Natural Products Association.
“Rather, I would think that, per the warning letter, the agency is just ensuring that any new drugs introduced in the market, whether by intent or lack of knowledge of our country’s food and drug laws, go through the proper approval process to protect the person who matters most: the consumer.”