The FDA is the ultimate guardian of preventing misleading information and claims. At the same time, it’s a huge roadblock to products that may have merit and efficacy. Proving efficacy in fact, is not always possible, especially within the costly FDA guidelines and within a reasonable time frame.
The recent opinion article on this in USA Today highlights the FDA’s efforts to “take action against unscrupulous actors who are marketing unlawful products related to this outbreak.” Dr. Hahn further points out that there are no FDA approved products to prevent, treat or cure COVID-19. That’s true. But that doesn’t mean that there are products, herbal or otherwise that aren’t effective.
It simply means that these products haven’t gone through the rigorous and expensive FDA protocol and therefore cannot make claims. In fact, a number of herbal compounds have demonstrated significant anti-viral efficacy in the lab and at times anecdotally. Now consider what it would take to prove efficacy. One would have to have a significant number of volunteer patients and infect them with the virus. Half would get a placebo and half would get the proposed product. I don’t think that’s going to happen. Not any time soon. Imagine the cost to perform this test, then the liability associated with it. And at the end, would there be a proprietary product to make up for the cost? Not likely, as the herbal world is rather unprotected from a patent standpoint with some limited exceptions.
Just because the product isn’t FDA approved, doesn’t mean it isn’t effective. However, claims should never be made for untested products. Never. Supportive documentation, including laboratory data and researcher credentials should be displayed so that the consumer can make an intelligent choice.
Richard Goulding, M.D.