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Two weeks ago I detailed the pervasive problem of poor quality supplements. The main reason for this seems to be weak regulatory standards that prioritize the rights of manufacturers to sell supplements over the rights of consumers to buy safe, high quality, properly-labelled products. Call it “health freedom“, where the freedom belongs to producers, who in many countries are largely freed from most of the quality and safety regulations that are in place for licensed prescription and non-prescription pharmaceuticals. The result of weak regulation is that few supplements sold on the market today have been properly tested for safety or effectiveness, and there are few quality standards for the production of these products.

Not surprisingly, there are persistent signs that consumers may face real risks to their health from using these products. Now a new study from Australia confirms what past studies have already shown: adulterated and contaminated herbal remedies are the rule, rather than the exception. They often contain undeclared ingredients ranging from potential allergens to heavy metals to endangered species.

At a minimum, we should expect supplements to be labelled properly. Consumers should know what they are paying for, and get what they pay for — anything else is fraudulent and potentially very dangerous.

So how does a consumer know that the label on a bottle of supplements is accurate? It’s almost impossible. With drug products, drug regulators inspect manufacturing facilities, verify production standards, and enforce the quality and consistency of the final product. When it comes to supplements such as herbal remedies, none of this may occur. Not only must the source material be verified, but a lack of contaminants must be verified. Herbals and botanicals are plant-based products that are natural concoctions of chemicals which are rarely purified or standardized to contain a predictable amount of any single active ingredient. Unless the manufacturer tests rigorously for specific additives, chemical adulterants, or toxic substances (like heavy metals), there is no way to know for certain that a herbal remedy is pure and uncontaminated. There is no routinely-conducted quality testing, so consumers are completely at the mercy of the manufacturer’s own quality assurance process that must confirm the presence of the desired substance and also the absence of contaminating substances. And there is no evidence that this is taking place.

Endangered species, pharmaceuticals, and heavy metals in your herbal remedies

A group of Australian researchers recently published a study of legally purchased Traditional Chinese Medicine (TCM). They used a series of molecular tests to see if what was on the label was actually in the bottle, and then further tested the products for pharmaceuticals, heavy metals, and other contaminants. What they found was a startling lack of product quality, and in some cases, what appears to be the deliberate adulteration of TCM with prescription and non-prescription drugs.

The researchers purchased 26 TCM products from retail stores in Australia, and directly from Australian TCM practitioners. Samples included tablets/capsules, teas, and one liquid sample. They first attempted to do a DNA analysis, and found sufficient DNA in 22 of the samples. There was so much plant contamination that the authors noted the number of ingredients were often “too numerous to list” and so they highlighted the most concerning ingredients. For instance, one product contained Asarum (TCM1) which contains aristolochic acid, a strongly carcinogenic (and natural) substance which has been banned worldwide.

Half of the products they purchased were not even legally approved by the Therapeutic Goods Administration (TGA), yet even that approval was no mark of quality: contamination was found in products whether they were approved or not. Plants and animals not listed on the label were found in most products, including:

the snow leopard (an endangered species)

cat

dog

rat

shrub frog

pit viper

a variety of bovids (such as goats)

The contamination doesn’t end there. A wide array of pharmaceutical contaminants was also found in the samples including:

analgesics like acetaminophen

antihistamines

steroids

anti-inflammatories like ibuprofen

erectile dysfunction drugs like sildenafil (Viagra)

antibiotics

stimulants

The anticoagulant (“blood thinner”) warfarin, used in rat poison

Most spectacularly, clinically significant amounts of two neurotoxins, brucine and strychnine

Twenty-five samples were screened for the heavy metals arsenic, cadmium, and lead. Twenty contained at least one heavy metal. Eleven contained all three metals. In many cases the amount consumed per day, if the product dose instructions were followed, would result in heavy metal consumption that exceeded safe levels.

The bottom line? Only two of 26 products tested were not found to contain any undeclared substances:

Manufacturing mistakes? Unlikely!

Is sloppy manufacturing and cross-contamination between different products to blame? Unlikely, given the pattern of contamination observed.

One sample (TCM18) was sold as weight-gain promoting product. It was adulterated with both cyproheptadine and the steroid dexamethasone, both of which are drugs that can increase appetite.

Another (TCM2) sold as product for “reducing hay fever” and “nasal secretions” contain a stimulant/decongestant, ephedrine, an analgesic, salicylic acid, an antibiotic, amoxicillin, and a blood thinner, warfarin. It is frightening that none of these ingredients were actually disclosed, creating a real risk of harm.

Finally, TCM8, marketed for “arthritis” and “pain” contained traces of the endangered snow panther, as well as tiger. Tigers have a long history of use in TCM, a prescientific belief that is driving the poaching of these animals, risking their extinction.

Who is happy with the status quo? Manufacturers.

Loose regulatory structures in Australia (and worldwide) have resulted in TCM remedies that largely fail to meet even basic quality standards for medicines. There is no acceptable reason for contamination (and adulteration) of TCM, yet this appears to be commonplace based on the sample studied. Perhaps not surprisingly, the Chinese Medicine Society in Australia feels the status quo is acceptable, and warns against anything that might result in products that meet basic health and quality standards:

The Federation of Chinese Medicine Society of Australia said the study provides no cause for concern, saying contamination would not be widespread in Australia. The society’s president, Professor Lin Tzi Chiang, acknowledged that some manufacturers might not be complying with standards set by the TGA, but said by and large most manufacturers would be doing the right thing. “Unfortunately for sure, there might be one or two products that it might happen like that, but it cannot be blamed on the whole profession,” he told SBS World News. He warned against over-regulation of traditional Chinese medicines, saying it would place an unfair burden on the industry and profession.

The evidence demonstrates otherwise. 92% of products tested failed to meet quality standards. A single adulterated or contaminated pharmaceutical product in a country like Australia would trigger a national recall and quite likely legal repercussions for the manufacturer. Yet contamination and adulteration appear to be business as usual in the TCM industry, where advocates are oblivious to the possibility of harm, and don’t even mention the right of consumers to purchase products that don’t contain unlabelled Viagra, dog, endangered species, or neurotoxins.

Still no evidence of effectiveness

All of the problems with TCM products found in this study need to be considered in the context of what we know about their efficacy, because ultimately a decision to take any product to improve our health needs to balance expected benefits against known risks. With TCM, any benefits we can expect are unclear. While the specific products studied in this analysis are not named, I’m not aware of any TCM product that is backed by good evidence of efficacy or safety. Even if it was effective, how could we be confident that it wasn’t due to the inclusion of prescription drugs?

Given the lack of any established benefits, and the almost certain likelihood that any given TCM product (in Australia, at least) is probably contaminated or adulterated, consumers are in the worst possible situation. I can’t think of any circumstances where the benefits might be clear enough to outweigh the risks.

Regulation of the supplement industry has been approached with a light touch, and now the consequences are being documented. The idea that herbal remedies including TCM are safe and effective is a marketing strategy based on a fallacy. Consumers may risk their own health when they buy products that are quite likely to be adulterated and contaminated. The industry’s unwillingness to recognize the problem and to clean up its own act is telling — these companies prioritize profits over consumer safety. And as long as consumers keep buying their products, and regulators do nothing, there’s little reason for the situation to change. At Science-Based Medicine we continue to advocate for more rigorous standards for supplements, herbal products and TCM — standards that are equivalent to drug products, where products are tested for quality and where claims of effectiveness must be backed by evidence. Until standards improve, or unless you don’t mind some endangered species or heavy metals in your remedy, you’re better off steering clear of TCM.

Photo a compilation of images from Flickr users: Martin L, Jean-Jacques Boujot, Tambako The Jaguar and Care_SMC used under a CC licence.