What are the concerns with Chinese herbs?
Just as we can have contaminants in our water, such as lead and arsenic, we can also find them in the plants that drink up that water. For this reason ongoing testing is large part of answering the question, “Are Chinese herbs safe?” Unfortunately, the New York’s Department of Health (DoH) recently sent out an advisory notice to healthcare providers after discovering high levels of heavy metals in an over-the-counter Chinese formula. Their announcement read:
In January 2016, DOHMH identified elevated levels of lead and/or mercury in a dietary herbal supplement called Emperor’s Tea Pill purchased over-the-counter in NYC. According to the product packaging, this supplement, manufactured in China by Lanzhou Traditional Herbs, could be used to ‘help maintain body’s natural balance.’ The levels of heavy metals found in Emperor’s Tea Pill ranged from being slightly elevated with up to 3.7 parts per million (ppm) lead, which is approximately two times the permissible limit for lead for certain food additives, to 200 ppm mercury, which is 200 times the permissible limit for mercury.
When I called NY Poison Control to receive more information on the supplement (as suggested by news reporting on the subject), they suggested to me that the DoH would pull all FDA-unregulated “Emperor’s Tea Pill” products (i.e. Tian Wang Bu Xin Dan), regardless of brand. Due to the health risks involved with heavy metal toxicity, including damage to the brain, kidneys, and nervous and reproductive systems, they are strongly encouraging anyone who has been taking this product be tested. If this includes you, please contact your healthcare provider about heavy metal testing.
If you look at the herbs in question (see: above cited news report), the packaging looks quite similar to another brand, Min Shan:
Min Shan is a brand exclusive to the distributor, Mayway, a reputable distributor in the US who employs third-party testing. I emailed Mayway after receiving the DoH announcement, requesting they release a statement to clarify. Their response, “It’s Not Ours!” goes into detail around counterfeits, how to spot them, and more on the safety measures of their own product. If you’re buying herbs from a local mom-and-pop store in Chinatown or the International District, you want to be sure to note the differences!
What makes Chinese herbs safe?
Chinese herbal medicine quality varies greatly between brands based on a number of factors. Here are a few of the top differences:
Good manufacturing practice (GMP) is the effort to maintain consistency and control throughout the manufacturing process. WHO explains, “GMP covers all aspects of production; from the starting materials [e.g. herb identification testing], premises and equipment to the training and personal hygiene of staff.” They go on to explain that while they have developed detailed GMP practices, many countries have formulated their own. These guidelines are employed throughout the day. The important thing to note here is not all countries adhere to the same GMP practices; so “GMP-compliant” doesn’t always mean exactly the same thing. Nonetheless, a GMP-certified product will be one that you know has undergone some level of manufacturing regulation. So, are Chinese herbs safe if they have a GMP label? Well, you might have noticed that the photo included with the article on the contaminated formula (see: report above) features a “GMP” sticker….
Are Chinese herbs safe (or safer) if manufactured outside of China?
As a subcategory here, you may be interested to know there are popular [Chinese] herbal brands coming out of China, Japan, Taiwan, and the US. While some Chinese herbs are grown locally in the US, most are not. You might think of herbs like wine – with terroir being a factor in their successful cultivation and efficacy. For this reason, I wouldn’t make any assumptions about the sourcing of the original material based on brand.
So, once a product is “GMP-certified” they might opt-into the Therapeutic Goods Administration (TGA) certification. TGA certification comes through Australia, and its purpose is to “[ensure] that therapeutic goods available for supply in Australia are safe and fit for their intended purpose.” When an international company chooses to receive an on-site inspection and certification through the TGA, you can know their manufacturing practice has been double-checked and held to stringent guidelines. Once certified, facilities are re-assessed no more than once a year.
Independent, third-party testing
When a distributor (or manufacturer) chooses to verify for their self that their final product holds to their purported standards, they may choose to hire a third party to test their finalized product, such as Eurofins. Whereas the GMP-compliance standard likely includes testing each batch of individual herbs for microbes and heavy metals, third-party testing is usually reserved for random batches.
At the time of writing this, I am only aware of one Chinese herbal distributor (who has their own herbal line) that is registered with the FDA: Kamwo. They are open to random inspection by the FDA. The FDA considers dietary supplements a “type of food” (p3) so herbs are not regulated as prescription medications are, and FDA-registration is not required. To have this feather in your cap is more an informal way of saying, ‘I have nothing to hide!’ more than it’s saying, ‘Here’s one more protocol I’m using to ensure my products are safer than others.’
Are my Chinese herbs safe to take?
I hope you’re getting a sense now that all herbal products are not created equal. This is not an exhaustive list, of course, of safety measures and/or concerns. Many of same things affecting the question of “Are my Chinese herbs safe?” equally apply to our diet and environmental exposures. The answer isn’t just ignoring the issue *or* avoiding Chinese herbs. It’s a question well-worth examining. If you are gluten-free and rely heavily on rice products in your diet, I strongly encourage you to read the 2012 (updated 2014) Consumer Report on arsenic in rice.
While seeing a “GMP” sticker on the packaging might have been enough before, I’d suggest only buying a brand that employs third-party testing and that provides you the opportunity to view a Certificate of Analysis (usually completed on request). If you have questions about the products you’ve been taking, call your certified herbalist and/or the distributor to inquire into their safety standards. Heavy metal accumulates over time; so it’s not necessarily something you’d see the effects of right away. It’s not worth guessing about!