Why the lion's mane you're buying is probably bunk.

First off, our Lion's Mane is not a traditional water extract. The water is used to break down the chitin in the cell walls, but the entire mushroom material is kept in. So you don't lose anything that you would with a full solvent extraction. Ethanol will not change anything, as we're not using it to extract compounds. We have an 8:1 dual water/ethanol extract of Lion's Mane coming out soon, which is a traditional extraction. However, the 1:1 products keep ALL mushroom material in. You lose nothing.

I'm also going to rant a bit about the mycelium/fruiting body issue below. Keep in mind I am copying a lot of this from previous messages to people. So not all of it is directed at you.

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The main double-blinded clinical trial on humans using Lion's Mane used whole fruiting bodies, not mycelium:

Improving Effects of the Mushroom Yamabushitake \(Hericium erinaceus\) on Cognitive Impairment: A Double-blind Placebo-controlled Clinical Trial

The fresh fruit bodies of Yamabusitake were air-dried at 60 °C overnight and powdered. The test food was 250 mg tablets containing 96% of Yamabushitake, prepared by adding silicon dioxide and fat to Yamabushitake powder, and tablets of the same shape containing cornstarch and lactose instead of Yamabushitake powder (Table 1). The nutrient composition of the test food is shown in Table 2. The subjects took four Yamabushitake-containing or placebo tablets three times a day for 16 weeks.

It also found they were effective in humans, and that hericenones led to the increases.

Consequently, Yamabushitake can be regarded as a useful food for the prevention of dementia without any adverse effects. This effect may be attributed to promoting NGF by hericenones, but further studies are needed to clarify the mechanism.

So we have human trials that show the fruiting bodies of Lion's Mane improve cognitive impairment. We do NOT have any human trials showing the same for mycelium products. The study often linked for mycelium only used mouse astroglial cells IN VITRO. It certainly does not settle the debate on the matter, and does not invalidate IN VIVO human research regrading the fruiting bodies of Lion's Mane.

Here is another HUMAN clinical trial using the fruiting bodies of Lion's Mane:

Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake

It showed that whole fruiting body extracts of Lion's Mane significantly improved depression, sleep quality, and anxiety scores. This is valid human clinical research, not in vitro studies using mouse astroglial cells. The in vitro mouse study is certainly interesting, and we are working on a cultured mycelium extract of Lion's Mane that we can offer alongside our current fruiting body extracts. However, the human clinical research behind the effectiveness of Lion's Mane mushroom has used the fruiting bodies. Furthermore, the FDA says that you cannot call a mycelium product a "mushroom" since it is not a mushroom.

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074627.htm

Any food in which mushroom mycelium is used should be labeled to state that fact. Labeling should not suggest or imply that the food contains mushrooms. For example, a soup in which mushroom mycelium is an ingredient should not be labeled or sold as "mushroom soup" since that name by long consumer understanding and usage is preempted by soup containing real mushrooms.

In addition, their new draft guidance stipulates that a product may be considered "adulterated" if it uses the mycelium of the mushroom, instead of the fruiting body.

http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf

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What are examples of processes that chemically alter an article of food present in the food supply?

Below are some examples of processes that FDA would likely consider to involve chemical alteration. These processes would also be likely to affect the safety profile of a dietary ingredient. The examples below are intended only for the purpose of illustration and are not a comprehensive list of processes that result in chemical alteration.

See question IV.B.5 for further discussion on chemical alteration.

Use of a botanical ingredient that is at a different life stage than the life stage of the botanical ingredient used as a conventional food. Examples: making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.

So the FDA has stated and clarified their position on the matter: that mycelium is NOT a mushroom, and cannot be sold as such. If mycelium is used, it must be clearly labeled as such, and CANNOT reference clinical research regarding the whole fruiting body of the mushroom, as they are different ingredients. The current human clinical research on Lion's Mane has used fruiting bodies, and has shown them to be effective in a number of different measures. So that is what we sell. Our whole fruiting body extracts are not only the types backed by human clinical research, but also fall in line with the FDA regulations regarding the sale of mushroom products. If and when we sell a mycelium product, it will be properly labeled as such, and be a 100% cultured extract using fermentation, not a bunch of ground up rice filler. We clearly label our current extract as a whole fruiting body product, and are not misinforming anyone. If you want a product that is the same as the ones used in the two human clinical trials, our product is that.

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Remember, not all of it was directed at you. I've had a few discussions with people claiming that mycelium was needed instead of fruiting bodies. So a lot of that was directed more toward them. However, please do not state we are making fraudulent claims, or act like I don't care what the research states. I've done a massive amount of reading on this subject. The two human clinical trials surrounding Lion's Mane have used a powdered extract almost exactly the same as ours. They did not use ethanol extracts or mycelium. Remember, we are using the word "extract" to mean the breaking down of the chitin in the cell walls. This is in contrast to a full solvent extraction, where you only pull over the soluble materials, and discard the rest. Our 1:1 doesn't discard anything, so using a different solvent wouldn't solve(ha) anything.

We do have an 8:1 dual water/ethanol extract of Lion's Mane ready to release, once our bank gives us the okay. So if you want to try a more traditional solvent extraction, we'll have that up soon. Also, we are working on the possibility of a cultured mycelium extract, which would give the compounds in the mycelium, but not be mostly ground up rice. That's a longer ways off, but is something we are going to do. I care about the research and efficacy of these things just as much, if not more, than anyone. I don't just sell things for the hell of it. I am passionate about it. So I do get a little upset when people claim I am doing otherwise. I apologize if my wall of text was a little direct.