This is Ginkgo biloba — the maidenhair tree. A living fossil. Species surviving unchanged for 270 million years. One of the most studied medicinal plants on Earth, with a documented use history in traditional Chinese medicine spanning centuries. And in 2013, it became the subject of a rodent carcinogenicity study that has driven European regulatory concern ever since.
Let me tell you what that study found. And let me tell you what it actually means for you.
The US National Toxicology Programme conducted carcinogenicity studies administering concentrated ginkgo biloba extract to rats and mice by gavage — force-fed directly into the stomach — at doses of 100, 200, and 600 milligrams per kilogram of bodyweight per day. The results showed increased incidences of hepatoblastomas — a type of liver tumour — in male and female mice, and evidence of carcinogenic activity in the thyroid gland of both rats and mice
But here is what the regulatory discussion consistently omits about that study.
The dose translation problem.
The doses used in the NTP study — 100 to 600 milligrams per kilogram per day — far exceed any dose used in human supplementation. The standard human dose of ginkgo extract, in the form of the most rigorously studied preparation EGb 761, is 120 to 240 milligrams total per day. For a 70-kilogram adult, that is approximately 1.7 to 3.4 milligrams per kilogram per day.
The lowest dose that showed carcinogenic activity in the NTP study — 100 milligrams per kilogram per day — is approximately 30 to 60 times higher than the standard human supplement dose. At the 600 milligrams per kilogram dose — the one producing the most striking results — the exposure is approximately 175 to 350 times the human therapeutic dose.
Standard toxicological practice recognises that rodent carcinogenicity findings at very high doses do not automatically translate into human cancer risk at clinical doses. The US National Cancer Institute and the scientific advisory committees reviewing the NTP data noted the importance of dose context in interpreting the ginkgo findings.
The human clinical evidence.
The EMA's Committee on Herbal Medicinal Products, in its final assessment report on Ginkgo biloba folium, found that adverse event profiles of ginkgo and placebo were similar across clinical trials. The NIH LiverTox database is explicit: ginkgo has not been implicated in causing liver injury. The GuidAge trial a large placebo-controlled trial of EGb 761 involving 2,854 patients found no significant excess bleeding compared to placebo. Two long-term placebo-controlled trials of EGb 761 lasting five to six years found no increased bleeding risk.
This is the largest, most rigorously studied proprietary ginkgo preparation and the human clinical evidence does not reflect the toxicological signals from the high-dose rodent studies.
The ginkgolic acid issue is solved by standardisation.
Ginkgo preparations can contain ginkgolic acids, compounds with allergenic and potentially genotoxic properties at high concentrations. This concern has been addressed in practice: EGb 761 and compliant standardised preparations have very low ginkgolic acid content, well within international safety guidelines. Product standardisation eliminates this concern. The appropriate regulatory response is quality standards specifying maximum ginkgolic acid content, not prohibition of ginkgo itself.
The antiplatelet question — clinical, not catastrophic.
Ginkgo has antiplatelet properties — it may reduce platelet aggregation and enhance blood fluidity. In combination with anticoagulant or antiplatelet pharmaceutical therapy, this may require monitoring. The EMA HMPC notes this as a precaution. However, the GuidAge and long-term EGb 761 trials conducted specifically to investigate this concern found no statistically significant excess bleeding in populations taking ginkgo. The concern is real enough to warrant prescriber screening. It is not confirmed in controlled clinical data as a major bleeding hazard at standard doses.
The memory and cognitive function evidence.
Ginkgo has a substantial evidence base for cognitive support, particularly in early cognitive decline. Multiple controlled trials of EGb 761 show statistically significant benefits. Removing ginkgo from the supplement market means removing one of the few evidence-based non-pharmaceutical options available to people concerned about their cognitive ageing.
A 270-million-year-old tree. Decades of human clinical trials showing safety. A carcinogenicity signal from rodent studies at doses 30 to 350 times the human therapeutic level. And it is on a restriction list.
The UK committed to align food supplement law with EU law under the SPS Agreement without parliamentary approval. Published at www.gov.uk/government/news/uk-eu-sps-agreement-legislation-in-scope .
Sign the petition. https://www.change.org/p/demand-uk-regain-control-over-food-supplements-regulation?recruiter=1403120945&recruited_by_id=ca366360-0a66-11f1-a119-071922cd5010&share_id=Qv72WrhZDN Respond to the consultation. Write to your MP at writetothem.com. Parliament must vote before ginkgo is restricted in the United Kingdom.
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