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:
The Aristolochic Acid Chronicles continue.
I’m in touch with some scientists, concerned acupuncturists, and people with kidney disease who would still like to use safe TCM herbs. All are very aware of the scary reality of Aristolochic Acid, found in some species of Chinese herbs (or their look-alike substitutes) such as Mu Tong (Akebia/Aristolochia), Xi Xin (Asarum), and Fang Ji (Stephania/Aristolochia). The Aristolochic Acid herbs should be totally out of the supply chain now, so I hope this is largely for historical interest.
I was doing some more PubMed surfing and found this recent study of Chinese herbalists in Taiwan, showing that there is a significant increased risk of getting kidney, bladder, and liver cancer from working with Chinese herbs over a period of years.
I’m back from a fabulous Hawaiian vacation. It’s great that Aloha has several nuanced meanings, including hello and goodbye.
The ancient Taoists talked of the Islands of the Immortals in the Eastern Sea (they called them Peng Lai). Hawaii is a pretty close match. No snakes! There were no mammals until humans introduced them. The effort to combat stowaway rats by introducing the mongoose didn’t go so well, either (rats are nocturnal, the mongoose is diurnal, never the twain shall meet). After a very busy December, it was great to take a break. I highly recommend a Hawaiian vacation, especially if you live where it is cold and snowy for months.
My break gave me time to contemplate my path: my business, blog, projects, personal health… To be honest, I even considered taking down this blog to focus more on making money. I would really like to pay off my student loans and spend more time in Hawaii. Writing about Traditional Chinese Medicine (TCM) and Complementary and Alternative Medicine (CAM) from a critical and consumer-protection perspective has taken much time but hasn’t increased my income at all. Probably the opposite has occurred. The thing is, I am not doing this for the money. I was very clear with myself when I chose the TCM/Taoism path 20 years ago that it was not about making money. At the time, I felt I was on a spiritual path to help people with natural medicine, help the planet through increasing humanity’s respect for nature, and grow as an individual by learning and practicing what I called “Taoist arts and sciences.”
Deep down I am still influenced by Taoist and Zen philosophy, but have become increasingly skeptical of groups, belief systems, and teachers claiming to be Taoist or Zen. I don’t really want to be seen as a “Taoist” or “Zennist.” The principles of observing nature, not being attached to ideas, beliefs, or things, and not resisting change are still core to my internal attitude. However, I identify these principles more with science and logic than a religion which seeks to avoid reincarnation or attain immortality.
My dear Uncle, a Montana libertarian who has been involved in law and politics for decades, sent me this note today. I wrote a response and thought to share it with my blog readers, as it touches on many of the sensitive issues surrounding freedom, science, and the herbal medicine business. Even though I doubt he needs anonymity, I made it so.
I am attaching a copy of a solicitation I received from the Center for Inquiry
with which they are attempting to have me donate to them. As stated in this solicitation, it is on their agenda to “demand that homeopathic (treatments) go through the same rigorous scientific and medical scrutiny that all other FDA approved medicines go through.”I believe having all new treatments submit to
the FDA monopoly would be horrible. It is nice to know who our enemies are.
Your Uncle Continue reading
Today via Twitter I learned that an Oregon herb company I knew nothing about got in big trouble with the FDA. This was hot on the heels of an anonymous blog comment from an acupuncturist dismissing some of my consumer protection warnings as being a personal vendetta from my insecure shadow side.
GRAPHIC IMAGE WARNING: Several disturbing images of people who used Herbal Black Salves to treat their own face cancers, leading to disfiguring chemical burns and missing noses, are included below.
Let’s take a look at this new FDA case together, and I’ll let you know where I stand.
I’m also an Oregon herb company, an herbalist with a Master’s Degree, and have researched the FDA’s Food, Drug, and Cosmetics act in detail for years while trying to responsibly grow my business. It’s possible that some day I’ll get a warning letter from the FDA, though that seems unlikely as I actually try to learn and follow their rules.
Integrative Therapeutics is one of the giants in the “high-end” supplements world. They were formed by the merger of several already big companies, including Naturopathic Formulations (NF), Tyler Encapsulations, and some others.
When I was in acupuncture school in Portland, I was friends with one of the NF family members, and was sad when NF was sold to a non-Oregon large conglomerate. Still, I try to adapt to reality before complaining. I added 352 Integrative Therapeutics items to my catalog and was careful to follow their highly restrictive Internet Reseller Policy.
One aspect of meeting the Integrative Standard is to sell such products online at or above the suggested retail prices. Any advertisements, discounts, rewards programs, coupons, special offers, sales, promotions, etc. must explicitly state “Not valid on Integrative Therapeutics’ products” and products must check-out at or above suggested retail pricing. (from the Integrative Therapeutics Internet Policy)
I’ll be removing all of their items after I write this post.
As usual, the Internet is very hard to control. Integrative Therapeutics has been unable to enforce their internet policy of “no Amazon, no discounts,” which means their products are available at a discount on Amazon and elsewhere. Their policy (excerpted below) specifically says Amazon is not OK and discounts are not OK.
Like most bloggers, I appreciate comments my readers share. It’s good know I have readers who find my posts thought-provoking, whether or not they agree with me. Here are some recent comments which deserve more space for proper response than the comments format permits:
From: Arthur Grollman MD on Kidney Failure and Bladder Cancer due to Aristolochic Acid, is Xi Xin/Asarum implicated? What would Zhang Zhong Jing do?
As the (American) co-author of the PNAS paper that stimulated this thoughtful blog, I commend those who wrote it for the constructive criticism it contains and its wise recommendation that Asarum in the form of Xin Xin should
never be used in TCM, as the toxic component (aristolochic acid) accumulates in the body in the form of carcinogenic aristolactam-DNA adducts. In other published research, we have detected these adducts 40-50 years after the Aristolochic acid containing herb was last taken.
How fabulous to get a comment from a co-author of this study! Thank you, Dr. Grollman for stopping by. I realize that he is probably also thrilled that an acupuncturist has paid attention and taken his findings seriously. How sad to think that some acupuncturists remain determined to dodge the science and law and continue prescribing these herbs just because they are in some very old books… I have written many posts about the herbs which contain Aristolochic Acid and how these events have crossed my path. ”Sleuthing Beverly Hames’ Kidney Failure” is the one I’d recommend most. There are thousands of Traditional Chinese Medicine patients around the world who now have this DNA damage (detectable for 50 years!) which vastly increases their cancer risk. Most of them don’t know about it, so they aren’t looking out for the early signs of kidney and bladder cancer. Acupuncturists should note that some US-based herbal supplement manufacturers who knew their products caused kidney failure never did recalls or notified acupuncturists to throw away their existing stock and warn patients to stop using it. So much for trust and prevention…