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Chinese herbal medicine in the United States and Europe: practitioners, products, regulation and evidence

Quick answer

How is Chinese herbal medicine regulated in the United States and Europe? In the United States most states regulate acupuncture, and Chinese herbal products are sold as dietary supplements under DSHEA (1994), generally without FDA approval before sale. In Europe, Directive 2004/24/EC offers a registration for traditional herbal medicines that needs 30 years of use, 15 of them in the EU, and a 2022 review counted 7 Chinese herbal products registered through it. A 1998 California survey found undeclared drugs or heavy metals in 83 of 260 patent medicines (32%).

Survey and trial figures: 32% of 260 Asian patent medicines in a California survey held undeclared drugs or heavy metals; 3 of 75 herbal trials for IBS in the Cochrane review were high quality; 116 adults took part in the Australian IBS trial of 16 weeks.
Source: Ko, NEJM 1998;339:847 (PMID 9750079); Liu et al., Cochrane 2006 (PMID 16437473); Bensoussan et al., JAMA 1998;280:1585 (PMID 9820260). SuppleGut chart, free to reuse with attribution.

Chinese herbal medicine reached the United States and Europe as imported products and as a professional field attached to acupuncture, without the state system it has in China. This guide covers how it arrived, how practitioners are certified, how products are regulated in each place, what the contamination surveys found, how Japan’s Kampo differs, how brands position their products and what trials in Western populations show. The system itself is explained in What is traditional Chinese medicine? and its vocabulary in the glossary guide; the TCM section lists the rest of the series.

How it arrived

As reported, the route ran through acupuncture. James Reston of the New York Times had his appendix removed in Peking in 1971, and wrote that acupuncture needles two nights later eased the pressure and distension in his stomach within an hour. After President Nixon’s visit in 1972, White House physicians came home with accounts of acupuncture anesthesia, the public was excited and the medical profession was skeptical. The American Society of Anesthesiologists warned against premature use, the NIH announced a research program in 1972, and an NIH committee asked for more controlled studies. Most states that acted in those years treated acupuncture as a medical procedure for physicians; Nevada passed a law that created a licensing board and did not require applicants to be physicians (Taylor, 1973).

Practitioners and licensure

The NCCIH says most states and the District of Columbia regulate acupuncture practice and most require certification from the NCCAOM, the national certifying body. The NCCAOM, whose website now sits at ncbahm.org, says its certification or exam scores are used for licensure in 46 states plus the District of Columbia. Herbs are certified separately: the NCCAOM offers a Chinese herbology credential, and its state page lists Illinois, Massachusetts, New Jersey, Ohio and the District of Columbia as requiring herbology or Oriental medicine certification to practice herbs, with Pennsylvania and Vermont requiring the herbology exam alone. So in some states Chinese herbal medicine is practiced under the acupuncture license, and in others it needs a further credential. The NCCIH advises asking any practitioner about training and experience.

Products as dietary supplements

In the United States Chinese herbal products are dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA’s own summary is that manufacturers are responsible for substantiating the safety of their ingredients and the claims they make, that they generally need no FDA approval before selling, and that the FDA acts against an unsafe product after it reaches the market (FDA backgrounder). Disease claims move a product out of the supplement category. In a 2019 warning letter, the FDA found that website and label claims made 13 ActiveHerb and Guang Ci Tang products, among them the Huo Xiang Zheng Qi formula Stomacare, unapproved new drugs, and separately cited labels that did not name the plant part in English (FDA, 2019).

Safety: aristolochic acid, adulteration and metals

Aristolochic acid. In 1993 a Brussels team reported nine women under 50 with rapidly progressive kidney fibrosis after a slimming regimen that had added two Chinese herbs in 1990 (Vanherweghem et al., Lancet, 1993). A manufacturing error had replaced Stephania tetrandra with Aristolochia fangchi; among 39 patients who agreed to preventive surgery, 18 (46%) had urothelial carcinoma, and a cumulative dose over 200 g carried a higher risk (Nortier et al., NEJM, 2000). The FDA’s Import Alert 54-10, which trade press dated to 2000 and which was revised in 2001, allows detention of products containing Aristolochia species and certain Asarum, Cocculus and Thottea species; the alert says past outbreaks arose when a plant was mislabeled or Chinese names were misinterpreted.

Adulteration and metals. The surveys describe the products sampled and do not extend to every product:

What a buyer can check is limited: Latin names and plant parts, a Supplement Facts panel with amounts, and a third-party heavy-metal result from the brand. Are Chinese herbal supplements safe? goes through the surveys and case reports.

Europe

Directive 2004/24/EC created a simplified registration for traditional herbal medicinal products. The EMA describes it as covering products with at least 30 years of use, including 15 in the EU, for mild conditions, without medical supervision and not injected; no safety and efficacy trials are required. A review counted 7 Chinese herbal products registered this way, 5 single herbs and 2 multi-herb products (Wang et al., Chinese Medicine, 2022). The 15-year rule is one reason: a Chinese formula with documented use only in China does not meet it, and another review found that the main reason non-European herbal substances were left out of EU monographs was unmet directive requirements. In the UK the Traditional Herbal Registration scheme covers products, not practitioners, and Chinese medicine practitioners are not subject to compulsory registration (Barrister Magazine).

Japan’s Kampo, the contrast

Japan covers Kampo formulas under national health insurance: 148 prescriptions (Kono et al., 2015), of 212 formulas approved for clinical use (Okamoto et al., 2014). A multicenter placebo-controlled trial of rikkunshito, the Japanese name for Liu Jun Zi Tang, randomized 247 patients with functional dyspepsia to 2.5 g three times a day for 8 weeks. Responders were 33.6% against 23.8% on placebo (P=0.09, not statistically significant); epigastric pain improved more (P=0.04) (Suzuki et al., 2014).

The market

Brands sit in two channels, and the facts they state about themselves differ:

What trials in Western populations show

The Australian IBS trial randomized 116 adults who met the Rome criteria to individualized formulas (38), a standard formula (43) or placebo (35), five capsules three times daily for 16 weeks. Bowel symptom scores improved against placebo as rated by patients (P=.03) and gastroenterologists (P=.001); individualized formulas were no more effective than the standard one, and at follow-up 14 weeks later only the individualized group had kept its improvement (Bensoussan et al., JAMA, 1998). The 2006 Cochrane review pooled 75 randomized trials with 7,957 participants and tested 71 herbal medicines; only three double-blind, placebo-controlled trials were of high quality. Against placebo, a standard Chinese formula, individualized Chinese herbal medicine and Tong Xie Yao Fang improved global symptoms, and no serious adverse events were reported; the authors advise caution with the less rigorous trials (Liu et al., 2006). The trial tables are in Does Chinese herbal medicine work for IBS? and TCM formulas for digestion: what the trials show.

The products in this catalog

traditional Health Concerns Six Gentlemen A modified Xiang Sha Liu Jun Zi Tang of eight Chinese herbs in a vegetable capsule, taken two at a time between meals for weak digestion with gas, bloating and loose stools. Buy it at Amazon$1.99 a day
traditional Health Concerns Quiet Digestion A modified Bao He Wan formula of 13 Chinese herbs plus coral calcium in a vegetable capsule, taken two at a time between meals for fullness, gas and nausea after eating. Buy it at Amazon$2.39 a day
traditional Snap Dynasty Stomach Chi An 11-herb Chinese blend built on the Liu Jun Zi herbs (pinellia, poria, ginseng, atractylodes and others) in a gelatin capsule, taken two at a time up to three times a day. Buy it at Amazon$1.50 a day

Common questions

Are Chinese herbal practitioners licensed in the United States?

Acupuncture is regulated in most states and the District of Columbia, and most require NCCAOM certification, according to the NCCIH; the NCCAOM says 46 states plus the District of Columbia use its certification or exams. Herbal practice sits under those licenses in some states, and some require the separate Chinese herbology credential.

How are Chinese herbal products regulated in the United States?

They are dietary supplements under DSHEA (1994). Manufacturers are responsible for substantiating safety and claims and generally need no FDA approval before selling, and the FDA acts after a product reaches the market. Disease claims can make a product an unapproved drug, as in the FDA’s 2019 warning letter to ActiveHerb.

What is the FDA’s aristolochic acid import alert?

Import Alert 54-10 allows the FDA to detain products containing Aristolochia species and certain Asarum, Cocculus and Thottea species. It followed Belgian cases of kidney failure in women who took slimming pills in which Stephania tetrandra had been replaced by Aristolochia fangchi; 18 of 39 patients who had preventive surgery (46%) had urothelial carcinoma.

Can Chinese herbal products be registered as traditional herbal medicines in Europe?

Under Directive 2004/24/EC a product needs 30 years of use including 15 in the EU, for mild conditions. A 2022 review counted 7 Chinese herbal products registered this way, 5 single herbs and 2 multi-herb products.

How many Chinese patent medicines contain undeclared drugs or heavy metals?

A California survey found undeclared drugs or heavy metals in 83 of 260 Asian patent medicines (32%), and a Dutch survey found mercury, arsenic or lead in 186 of 292 Asian traditional preparations (64%), with 59 (20%) likely to exceed safety limits. The surveys describe the products sampled and do not extend to every product.

How does Japan handle Kampo differently?

Japan covers 148 Kampo prescriptions under national health insurance, mostly as standardized extracts prescribed by physicians. Elsewhere, including the United States, Chinese formulas are sold as supplements without that coverage. A trial of rikkunshito in 247 patients showed 33.6% responders against 23.8% on placebo, which did not reach significance (P=0.09).

What do trials in Western populations show?

An Australian trial of 116 adults with IBS found symptom scores better on Chinese herbal formulas than placebo over 16 weeks. The Cochrane review of 75 trials, 7,957 participants, found some formulas improved global symptoms but rated only three trials as high quality. Does Chinese herbal medicine work for IBS? has the detail.

Sources

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