A new study out of Australia looked at 26 different Traditional Chinese Medicine (TCM) products purchased from stores. They performed three types of analysis: heavy metal screening, toxicological analysis, and DNA sequencing. They found that 92% of the products tested had at least one type of contaminant.

This adds to a growing list of studies and revelations about how poorly the supplement industry is regulated, and raises further concerns about the overall quality of herbal and supplement products.

A 2008 study found that about 20% of ayurvedic herbal products contained heavy metal contamination, often at levels high enough to be toxic.

A 2013 study published in the BMC found that:

“Although we were able to authenticate almost half (48%) of the products, one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30/44 of the products tested and only 2/12 companies had products without any substitution, contamination or fillers.”

A 2014 study published in JAMA found that half of the product recalled by the FDA for being adulterated with banned drugs were dietary supplements, including up to one third of products purchased online. Further, when the FDA followed up they found that 6 months after they had issued a recall for adulterated supplements, two-thirds were still on the market and still contained the banned drugs.

These studies and other incidents have raised concerns among some regulators that the self-regulating “honor system” that is currently in place for supplements in most countries perhaps is not working as intended.

This new study is likely to add fuel to the fire. To go into more detail, they found:

Genetic analysis revealed that 50% of samples contained DNA of undeclared plant or animal taxa, including an endangered species of Panthera (snow leopard). In 50% of the TCMs, an undeclared pharmaceutical agent was detected including warfarin, dexamethasone, diclofenac, cyproheptadine and paracetamol. Mass spectrometry revealed heavy metals including arsenic, lead and cadmium, one with a level of arsenic >10 times the acceptable limit.

None of this should be surprising to anyone who has been paying attention to the supplement industry and its critics. TCM has long incorporated animal products into their magical potions, including products from endangered species. Rhino horn, tiger bones, and bear gallbladder are common ingredients. This tradition is based largely on the notion of sympathetic magic, or the notion of a life force. Some essence or aspect of the animal is hoped to be conferred by consuming it.

Heavy metal contamination may have two sources – accidental contamination from poor production methods, and deliberate adulteration for alleged health benefits. Regardless of the source, these exist in some samples at high enough doses to cause toxicity.

The third category of contaminants is the most telling – deliberate adulteration with pharmaceuticals. This suggests that the producers of these TCM products are not sincere. They don’t really believe in their magic, and are cheating by including drugs that actually work, or at least create the illusion of working. For example, it is common to include a stimulant, like ephedrine, in herbal supplements to give the consumer a quick buzz that will convince them the product is working.

This, of course, is a serious danger, especially since these drug ingredients are not listed on the label. From the list above, diclofenac should not be taken by people with kidney problems. Warfarin is a blood thinner and should only be taken under close monitoring to manage the risk of severe bleeding. Dexamethasone is a steroid that can have many side effects, especially if taken chronically.

Response from Proponents

The response from proponents in the herbal supplement industry or TCM industry has always been, essentially, “Nah ah.” Really, that’s it, naked denial. They have sometimes challenged the methods used in the analysis, but not convincingly.

This case is no exception:

National President of the Federation of Chinese Medicine Society of Australia Professor Tzi Chiang Lin said he did not believe such findings would be widespread across the industry.

“Of course, there are some people … that are not that good and they might be making something not very nicely,” he said. “[But you] can not [put] blame on the whole profession, it will be one or two individuals. It may be one or two cases [that have] happened, but not many,” he said. Professor Lin said the TGA’s current regulatory regime is “perfect”.

The study did not show that contamination was the exception, it showed that it is the rule – 92% of products had some form of contamination, 50% were deliberately adulterated with drugs.

Of course the industry thinks that current regulation is “perfect” because they basically have a free ride. They are free to commit fraud without consequence.

As I have written before, when regulations allow an industry to sell fake products with fake claims and little oversight, based largely on the honor system, it should not surprise anyone that the industry attracts con artists.

Conclusion

This new study from Australia is not an isolated study, but one of a chain of published research that shows serious problems in the international supplement industry. Contamination, adulteration, product substitution, and inaccurate labeling are rife within the industry.

In addition, there is precious little evidence that any of these products, even as advertised, are of any health benefit. So essentially we have billions of dollars wasted for risk without any real benefit.

They have survived largely by flying below the regulatory radar. They do this because their collective marketing campaign has convinced the public and regulators that supplements are safe because they are “natural” or because they have been in long traditional use. Neither of these assumptions are warranted.

The perception of low risk has also led to a regulatory environment that essentially is based on self report and the honor system.

What regulators and the public need to know is that reality is very different from what they have been sold. The industry is largely based on lies and deception. That their products are “natural,” “ancient,” or “traditional” is meaningless and should not be a substitute for effective regulation.

We are beginning to see a glimmer of recognition of these facts.