FDA Sends Another Warning Letter for H1N1

Tea for H1N1?

FDA has just posted a Warning Letter that was sent last July for Unapproved/Uncleared/ Unauthorized Products Related to the H1N1 virus. It is clear that problems continue from companies attempting to profit from public concern over H1Ni. It is not clear why it took FDA ten months to release the Warning Letter. What caught my eye was that this product was under the guise of traditional Chinese herbal therapy and that the instructions for use was “Flu Prevention Tea.” Many products are imported into the United States with the instructions “to make tea,” and little else. During the early 1990s I worked as a laboratory technician in the FDA San Francisco District Laboratory. We encountered many herbal products with the simple labeling “to make tea.” Some were legitimate herbal medicines and some were infested with what we casually referred to as “filth” because of insects and rodent hairs. There were also some fraudulent therapies.

Legitimate Inquiry into Alternative Therapies

The worst case I saw was a dried mushroom known as Ganoderma lucidum that was used as an unapproved HIV/AIDS therapy, at an exorbitant price. You can still buy the stuff on the internet for $139.95, although not as a AIDS cure. There was no way you could make tea from it. Unfortunately, because of obvious scams, some people have used the opportunity to disparage all alternative therapies. There are many legitimate, licensed acupuncturists who use Chinese herbal medicines. There are legitimate organizations that advocate Homeopathy including the American Association of Homeopathic Pharmacists. And some zealots, masquerading as “quackbusters,” are targeting legitimate research to investigate alternative therapies. We need more, not less, “adequate and well controlled” research into alternative therapies conducted under the review of registered IRBs. Still, the best therapy for H1N1 is a flu shot along with soap and water to wash your hands.

Consumers have a right to access to legitimate alternative therapies. Researchers have a right to conduct IRB approved research under FDA regulations. And FDA has the responsibility to protect consumers from clearly fraudulent therapies that pop up every time we have a public health emergency like H1N1. I think this is should be a clear public health goal. There is a link on the right column to find Fraudulent H1N1 Therapies (scroll down, beneath the calendar).

On The Blogroll: There is some interesting information on the European Medicines Agency GCP Inspections website.

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