Reading FDA warning letters and recall notices is highly recommended for anyone in the supplement or herb business. It can be discouraging for anyone who wants to legally introduce new dietary supplements to the market. This is partly because the laws and requirements are so complex, and partly because so many products currently on the market are clearly illegal and escape enforcement.
I’ve written several posts about Aconite (called Fu Zi in Chinese) in Traditional Chinese Herbal Medicine. Aconite is a powerful and toxic plant with some poorly understood narcotic alkaloids. The earliest Chinese herbals recognized that it could easily kill, and documented its use in China as poison on arrowheads. They also found that if it was prepared properly (mainly by boiling for a long time) and given in small enough doses, it had dramatic effects on some disease states. While it is used in tiny amounts in a few fairly common formulas, some modern practitioners, inspired by the 1800s Szechuan Fire School and a new Classical Chinese Medicine movement, are currently recommending Aconite in larger doses for a wider variety of patients.
Hong Kong researchers have found that Aconite prescribed by TCM practitioners is responsible for more adverse reactions requiring hospitalization than all other Chinese herbs combined. There is no antidote for Aconite poisoning; supportive care is given with hope that the body can process the toxins and survive.
Given this reality, if Aconite is given to a modern patient at the very minimum the patient deserves informed consent which includes being made aware of the cardiac symptoms of an adverse reaction. I have personally never called for banning of Aconite, but I see fewer and fewer instances where it seems reasonable or safe to recommend it. At one point I was so libertarian that I felt heroin and cocaine should be legal and freely available. I’m no longer that extreme. It is unrealistic to expect most people to sort through claims, promotions, research, facts, and deceptive advertising before deciding to try something which could result in death or permanent disability. There is a role for consumer protection beyond what occurs in a free market discourse. Unfortunate as it may be, the FDA is the first line for consumer protection against fraudulent and dangerous drugs and supplements in the USA.
As I was surfing the FDA warning letter databases for TCM-related matters, this letter popped up from the year 2000:
