Sheni Labs · Traditional & complementary medicine
Traditional and complementary medicine products
Herbal remedies, Ayurvedic and traditional Chinese medicine products, homeopathic preparations, “natural” cures sold online and the products of folk medicine. Used by a large share of the population, regulated unevenly, and the category where regulators most often find hidden pharmaceuticals, heavy metals and toxic plants. Sheni Labs evaluates these products with the same method as any other.
Why this category needs a lab
- Hidden drugs. “Herbal” products for weight loss, sexual performance, pain, diabetes and bodybuilding are the commonest carriers of undeclared pharmaceuticals (sibutramine, sildenafil analogues, corticosteroids, NSAIDs, hypoglycaemics); regulators publish such findings weekly.
- Heavy metals and toxic plants. Lead, mercury and arsenic in some Ayurvedic and traditional Chinese products; aristolochic acid (kidney failure and urothelial cancer); pyrrolizidine alkaloids in comfrey and some teas; Ephedra; kava and liver injury.
- Interactions. St John’s wort with antidepressants, contraceptives, anticoagulants and transplant drugs; ginkgo and garlic with anticoagulants; grapefruit-type effects on drug metabolism.
- Claims. “Cures”, “detox”, “boosts immunity”, “treats cancer” — claims that are prohibited for food supplements and unproven for most traditional products.
- Homeopathy. Products that are safe by dilution but marketed for conditions where delaying effective care causes harm; the evaluation concerns the claim and the labelling, not the ingredient.
What we check
- Identity. Botanical name (genus and species), plant part, preparation and extraction ratio; a product that names only a trade name or a vague “herbal blend” is “not assessable”.
- Regulatory status. In the EU, traditional herbal medicinal products need a traditional-use registration under Directive 2004/24/EC (the THMPD), with EMA monographs for the botanical; a product sold as a supplement must not make medicinal claims. In Georgia, the applicable classification as medicine, supplement or food, and import documentation.
- Evidence. The EMA Herbal Medicinal Products Committee monographs, Cochrane reviews and the WHO monographs on selected medicinal plants, graded by strength for each claim.
- Contaminants and adulterants. Certificates of analysis for heavy metals, pesticides, microbiology and — for high-risk categories — screening for undeclared pharmaceuticals; known toxic constituents.
- Interactions and populations. Medicines not to combine with; pregnancy, children, liver and kidney disease.
- Claims and labelling. Against EU Regulation 1924/2006 for supplements, medicinal-product rules for registered products, and plain honesty for the rest.
Verdicts
RecommendedEvidence supports the use; ingredients, dose and form are right; labelling is complete; no safety signal.
Acceptable with caveatsUsable, but with a stated limitation: weak evidence for a claim, a non-optimal form, an avoidable additive, or a price out of line with equivalents.
Not recommendedA safety concern, an undisclosed or misleading ingredient, an illegal claim, a dose that is ineffective or excessive, or no verifiable documentation.
Not assessableDocumentation insufficient to reach a verdict; we say what is missing.
Automatic “Not recommended”A product fails if any of its ingredients is prohibited for that use in any of the reference jurisdictions — Georgia, any EU member state, the United Kingdom, the United States, Canada, Australia or Japan — regardless of whether it is lawful where the product is sold. The reasoning is public-health reasoning: a prohibition by one competent regulator is evidence of a safety concern that does not stop at a border, and online sales do not stop at borders either. The verdict names the jurisdiction, the legal basis and the date. A dose limit or restriction elsewhere (as opposed to a prohibition) does not trigger the rule: it leads to “Acceptable with caveats” with the limit stated, or “Not recommended” if the product exceeds it by a wide margin.
Where the evidence comes from
- WHO Traditional Medicine Strategy 2025–2034 and the WHO monographs on selected medicinal plants
- EMA Committee on Herbal Medicinal Products (HMPC) monographs
- Directive 2004/24/EC on traditional herbal medicinal products
- US FDA tainted products marketed as dietary supplements
- National Center for Complementary and Integrative Health (NIH) — herbs at a glance
- Traditional and folk medicine reporting in Georgian from the Sheni network: shenimedicina.ge.
Verdicts on traditional and complementary products are issued on request; alerts from regulators appear daily under Product alerts. Get a verdict →
