Lion’s Mane
What’s New This Month
- FDA reports: FDA’s adverse-event database contains unverified reports naming lion’s mane products, including one report of a death; FDA says a report does not mean the product caused the event. 1
- FDA letters and alerts: We found no FDA warning letter about lion’s mane in the past two years; six earlier letters (2021-2023) cited illegal disease claims or manufacturing failures. One Canadian firm’s lion’s mane capsules have been subject to detention at the US border since 2022 for unapproved drug promotion (detention, not a recall). 2 3
- Lead notices: California 60-day notices allege lead in several lion’s mane powders. Seven notices since October 2024 name lion’s mane products, six for lead and one for THC. Notices are allegations. 4
- Health Canada limits: Health Canada’s mushroom monograph (31 October 2025) covers lion’s mane for adults. It sets 2.8 g a day of dried or powdered mushroom, or 12 g a day of aqueous extract, as the limit. 5
- Preprint still unreviewed: The largest trial is still a preprint funded by the product’s maker. Its full text reports no confidence interval. 6
- Mood trial re-read: The 2019 trial behind mood claims had no placebo and no blinding. 7
Overview
Lion’s mane is a shaggy white mushroom, Hericium erinaceus. It is sold as fruiting-body powder, extract or mycelium (the root-like threads), in capsules, gummies and coffees.
Labs find nerve-growth compounds in it. That was shown in cells and animals, not in people. 8
Labels claim sharper memory and focus, nerve repair, better mood and sleep, and less stress.
How We Researched It
We rate each marketing claim with a modified version of GRADE, the system medical researchers use to say how sure we can be (i.e., high, moderate, low or very low), and check each trial with the Cochrane risk-of-bias tool, which asks whether a study’s design could skew its results. For lion’s mane we screened about 66 records and used 22 evidence rows, mostly published from October 2022 through October 2026. We also checked 10 regulators and safety databases. We found no Cochrane review.
Research NotesTop three benefits
Cognition in Older Adults GRADE: Very Low
Pilot trials of 30 to 33 older adults found small gains, some only after adjustment or within groups. One mycelium trial raised perception speed after adjustment. 22 23
Bias check: Trials were small, and one gain faded after stopping. No larger independent trial has reported. 23
Alzheimer’s and Dementia GRADE: Very Low
One 49-week pilot of 41 people with early Alzheimer’s found no clear change on its main test. 11
Bias check: The study was small, and staff from its maker took part. Four people left over stomach or skin problems.
Nerve Regeneration GRADE: Very Low
A 2026 review of 11 nerve-injury studies found none in people. Nerve-growth effects are shown in cells and animals only. 9 8
Bias check: Eight of the 11 studies carried a high risk of bias. 9
Benefit Evaluation
| Claim | Claim Verdict | Research Confidence | Supporting Evidence | Safety Risk | Product Quality | FactStack™ Rating |
|---|---|---|---|---|---|---|
| Cognition in Older Adults | Promising | Very Low | Promising | Caution | Inconsistent | Caution |
| Alzheimer’s and Dementia | TBD | Very Low | TBD | Caution | Inconsistent | Warning |
| Nerve Regeneration | TBD | Very Low | TBD | Caution | Inconsistent | Warning |
| Mood | TBD | Very Low | TBD | Caution | Inconsistent | Warning |
| Sleep | TBD | Very Low | TBD | Caution | Inconsistent | Warning |
| Stress | TBD | Very Low | TBD | Caution | Inconsistent | Warning |
| Memory and Focus | Doubtful | Very Low | Doubtful | Caution | Inconsistent | Warning |
What Sellers Say vs. What Studies Show
| “Grows nerves and repairs damage.” | No human study supports nerve repair. A review of 11 nerve-injury studies found none in people. 9 |
| “Boosts memory and focus.” | Peer-reviewed trials in young adults found no overall gain in thinking. The one positive trial is an unreviewed preprint funded by its maker. 10 6 |
| “Lifts mood and eases anxiety.” | The 2019 mood trial had no placebo and no blinding. It compared changes within groups, not against a placebo. 7 |
| “Protects against dementia.” | One small Alzheimer’s pilot, with staff from its maker, found no clear change on its main test. 11 |
| “Pure and third-party tested.” | A seller’s test of 30 products found beta-glucan from under 5% to 82%. Health Canada recalled two lion’s mane products in 2026. 12 13 14 |
| “Safe and natural, with no side effects.” | Trials report mild stomach upset and rash. One case report describes severe lung injury after an extract. Another describes hives after fresh mushroom. 15 16 |
Trial ParametersIf you try it
| Who | Healthy adults who accept an unproven benefit. Avoid with mushroom allergy, in pregnancy or breastfeeding, and in children. |
| Dose | Studies used about 1.05 to 2 g a day. The 3 to 5 g a day often cited has no trial basis. |
| Ceiling | Health Canada’s licensing limit: 2.8 g a day of dried or powdered mushroom, or 12 g of aqueous extract. 5 |
| Duration | Pick one outcome first and judge it at 8 weeks. Stop for hives, breathing trouble, cough, chest pain or lasting stomach upset. |
| Form | Buy only with a batch certificate for beta-glucan, lead, cadmium, arsenic and mercury. Skip untested blends, gummies and coffees. |
| Ask First | Blood thinners or antiplatelet drugs (ask a pharmacist); memory concerns or MCI (see a clinician). Not a treatment for any disease. |
How to Take It
| Pick a plan | Studies used about 1.8 g a day of powder for 28 days, or 1.05 g a day of mycelium for 49 weeks. Pick one goal first. 10 11 |
| Time of day | Not reported. |
| With food | Not reported. |
| What to expect | Gains, if any, are small and unproven. Judge your chosen outcome at 8 weeks, then stop if nothing changed. 6 |
| How to take | Choose a product with a batch certificate for beta-glucan and metals. Stop for hives, swelling, cough or breathing trouble. |
Works With / Don’t Mix With
✓ Works with
Not reported. We found no supplement shown to add to lion’s mane’s effect.
⚠ Ask first / don’t mix
Blood thinners and antiplatelet drugs. Test-tube studies on platelets gave mixed results, and no human study exists. Ask a pharmacist. 17 18
Multi-mushroom powders, gummies and coffees. An EU alert in 2025 recorded one hospitalisation for lung inflammation after a multi-mushroom supplement containing lion’s mane. 19
Mushroom allergy. One case report describes hives and swelling within minutes of eating fresh lion’s mane. 16
Manufacturer Recalls & WarningsLast 36 months, newest first
| Date | Maker / Brand | Product | Action | Src |
|---|---|---|---|---|
| Sep 2026 | Tha Alkaline Hour; St. John Spice (Fountain Street); Present Moment Herbs; Shroomology (360 Labs; TJX); Nutra Champs | Lion’s mane powders and mushroom coffee | Five California Prop 65 notices (Oct 2025 to Sep 2026) allege lead. Notices are allegations, not findings. | 4 |
| Sep 2026 | Organika | Lion’s Mane Gummies, lot 251106 | Health Canada Type III recall (RA-82618): made at a foreign site not on the product licence. | 13 |
| Feb 2026 | MJ Nutra | Champignons et Adaptogènes (Hericium 610 mg) | Health Canada Type III recall (RA-81650): ingredient amounts differ from the label. | 14 |
| Jun 2025 | Not named | Unauthorised Hericium-Pleurotus-Reishi capsules | EU alert (France): one person was hospitalised with lung inflammation. | 19 |
| Dec 2024 | Canvast Supply (Shifters Bliss); Big Mountain Foods | THC candies with lion’s mane; Lion’s Mane Mushroom Burger (a food) | Two Prop 65 notices allege delta-9 THC and lead. Notices are allegations, not findings. | 4 |
Where to Buy
We compare products side-by-side not just on price, but on whether NSF lists the product as NSF/ANSI 173 Contents Certified (an independent lab confirms the label matches the contents), whether it is NSF Certified for Sport, whether USP lists it as USP Verified, and whether the seller says it is manufactured in the USA. We leave out a brand’s products for this supplement when, in the last 36 months, the FDA took action against that brand over this supplement (a Class I or II recall, a warning letter, an import alert or an advisory letter). We also leave out any brand with an FDA Class II recall or warning letter on any product. We also leave out any product named in a California Prop 65 notice or a non-US recall, along with that brand’s products of the same ingredient and form. Brands with other actions stay listed and are marked in the Recall Screen column. Our goal remains to provide you, the Consumer, with the information and data necessary to make an informed purchasing decision. Prices reflected below are static and subject to change.
Ratings above describe the ingredient’s research, not any product listed below.
| # | Retailer | Product | Price | NSF 173 | NSF Sport | USP | Mfg. in USA (per seller) | Recall Screen | Affiliate link |
|---|---|---|---|---|---|---|---|---|---|
| 1 | iHerb | EVLution Nutrition, Lion's Mane, 60 Veggie Capsules (500 mg per Capsule) | $8.64 | ✓ | ✓ | View on iHerb ↗ | |||
| 2 | iHerb | Force Factor, Lion's Mane, 500 mg , 60 Vegetable Capsules | $8.99 | ✓ | ✓* | View on iHerb ↗ | |||
| 3 | HerbsPro | Now Foods, Lion's Mane, 500 Mg, 60 VegCaps | $14.51 | ✓ | ✓* | View on HerbsPro ↗ | |||
| 4 | iHerb | Nutricost, Lion's Mane Mushroom, 90 Capsules (700 mg per Capsule) | $14.95 | ✓ | ✓* | View on iHerb ↗ | |||
| 5 | Green's Nutrition | Nutricost Lion's Mane Powder Organic 4 Oz | $17.95 | ✓ | ✓* | View on Green's Nutrition ↗ | |||
| 6 | iHerb | Sunwarrior, Be Well, Organic Lion's Mane, 5.3 oz (150 g) | $19.97 | ✓ | ✓* | View on iHerb ↗ | |||
| 7 | HerbsPro | Nature's Answer, Lion's Mane, 1500 Mg, 90 Veg Caps | $22.49 | ✓ | ✓ | View on HerbsPro ↗ | |||
| 8 | Green's Nutrition | LifeSeasons Therapeutics Lion's Mane Mushroom 60 Veg Caps | $23.00 | ✓ | ✓* | View on Green's Nutrition ↗ | |||
| 9 | Green's Nutrition | Host Defense Lion's Mane 60 Cap | $33.95 | ✓ | ✓ | View on Green's Nutrition ↗ |
Sources
1. CAERS adverse-event reports naming lion's mane products (openFDA food event records, e.g. 2025-CFS-008188). US Food and Drug Administration (openFDA), Data to 7 Jul 2026. api.fda.gov/food/event.json
2. Warning Letters table, full-text search for lion's mane. US Food and Drug Administration, 5 Oct 2026. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
3. Import Alert 66-41 (importalert_190). US Food and Drug Administration, Page published 1 Oct 2026 (listing 18 Jul 2022). www.accessdata.fda.gov/cms_ia/importalert_190.html
4. California Proposition 65 60-day notices naming lion's mane products. California Office of the Attorney General, 28 Sep 2026. oag.ca.gov/prop65/60-day-notice-list
5. Natural Health Products Ingredients Database: Mushrooms monograph (Hericium erinaceus). Health Canada, 31 Oct 2025. webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=mushrooms.champignons&lang=eng
6. Daoust A et al. Lion’s mane and cognitive performance in adults with cognitive complaints: randomized trial (preprint, not peer reviewed). medRxiv, 17 Apr 2026. doi.org/10.64898/2026.04.13.26350781
7. Vigna L et al. Hericium erinaceus improves mood and sleep disorders in overweight or obese subjects: open-label pilot trial. Evidence-Based Complementary and Alternative Medicine, 2019. doi.org/10.1155/2019/7861297
8. Kawagishi H et al. Hericenones and erinacines: stimulators of nerve growth factor (NGF) biosynthesis in Hericium erinaceus (review). Mycology, 2010. doi.org/10.1080/21501201003735556
9. Taib M et al. Lion’s mane and peripheral nerve injury: systematic review of 11 studies. Medical Sciences, 2026. doi.org/10.3390/medsci14010042
10. Docherty S et al. Acute lion’s mane supplementation and cognition and mood in young adults: randomized trial. Nutrients, 2023. pubmed.ncbi.nlm.nih.gov/38004235/
11. Li IC et al. Prevention of early Alzheimer’s disease by erinacine A-enriched Hericium erinaceus mycelia: pilot randomized trial. Frontiers in Aging Neuroscience, 2020. doi.org/10.3389/fnagi.2020.00155
12. We Tested 30 Lion’s Mane Supplements. Here’s What We Found.. Mycogenius, Jul 2026. mycogenius.com/blogs/articles/we-tested-30-lions-mane-supplements-heres-what-we-found
13. Health Canada recall notice: Organika® Gummies – foreign site not listed on site licence (ref. RA-82618). Health Canada, 15 Sep 2026. recalls-rappels.canada.ca/en/alert-recall/organikar-gummies-foreign-site-not-listed-site-licence
14. Health Canada recall notice: Champignons et Adaptogènes – affected lot contains concentrations for certain ingredients that differ from the label (ref. RA-81650). Health Canada, 26 Feb 2026. recalls-rappels.canada.ca/en/alert-recall/champignons-et-adaptogenes-affected-lot-contains-concentrations-certain-ingredients
15. Nakatsugawa M et al. Severe respiratory distress after Hericium erinaceus extract: case report. Internal Medicine, 2003. doi.org/10.2169/internalmedicine.42.1219
16. Watson K et al. Anaphylaxis to fresh Hericium erinaceus mushroom: case report. Annals of Allergy, Asthma & Immunology, 2022. doi.org/10.1016/j.anai.2022.08.931
17. Mori K et al. Inhibitory effect of hericenone B from Hericium erinaceus on collagen-induced platelet aggregation. Phytomedicine, 2010. pubmed.ncbi.nlm.nih.gov/20637576/
18. Poniedzialek B et al. The Effect of Mushroom Extracts on Human Platelet and Blood Coagulation: In vitro Screening of Eight Edible Species. Nutrients, 2019. doi.org/10.3390/nu11123040
19. RASFF notification 2025.4917: unauthorised Hericium-Pleurotus-Reishi capsules (France). European Commission (RASFF Window), 30 Jun 2025. webgate.ec.europa.eu/rasff-window/screen/notification/772255
20. Advertising mushroom products that are therapeutic goods. Therapeutic Goods Administration (Australia), 10 Oct 2025. www.tga.gov.au/resources/resource/guidance/advertising-mushroom-products-are-therapeutic-goods
21. Novel food consultations on Hericium erinaceus (Spain 2019; Finland 2025; Czech Republic 2026). European Commission, 10 Sep 2026. food.ec.europa.eu/food-safety/novel-food_en
22. Cernelic Bizjak M et al. Effects of Hericium erinaceus mycelium (erinacine A) supplementation on cognitive function and inflammatory markers in older adults: randomized trial. Journal of Functional Foods, 2024. doi.org/10.1016/j.jff.2024.106120
23. Mori K et al. Improving effects of Hericium erinaceus on mild cognitive impairment: randomized trial. Phytotherapy Research, 2009. doi.org/10.1002/ptr.2634
