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Cerebral Health In Trouble With The FDA?

I was reading through the current Nootropic news on reddit today and came across a letter from the FDA to CerebralHealth specifically stating that their products were not being processed in a way that is compliant with current FDA standards.

The text of the complaint is here:

The gist of the complaints that the FDA levvies against Cerebral Health are the following:

  • Failed to provide a master manufacturing record for each batch
  • Failed to establish product specifications for identity, purity, strength, and composition of finished batches
  • Failed to conduct any tests about the identity of products sourced
  • Failed to write written procedures for quality control of products
  • Failed to make production records

According to the FDA, Cerebral Health is guilty basically of not creating or following standards and procedures specifically regarding the quality of product. They also didn’t keep records on each batch that was created. These are both somewhat bureaucratic requirements, but they are requirements by law. Hopefully CH has been able to establish and follow these guidelines. These probably shouldn’t be particularly worrisome.

The thing that caught my eye however was that they failed to conduct a single test about the identity or purity of their sourced products. It seems upon reading the complaint, that they order different chemicals from different suppliers and then combine them to create their formulas. However, they never did any purity tests to specifically make sure that what was coming was actually what was coming. There were no GC/MS tests done to make sure that what they were purchasing was, say, Huperzine A, as opposed to some other chemical.

I also did some digging and noticed that this is not the first time that Cerebral Health has had a run in with the FDA. There was another complaint filed by the FDA that was published on January 7, 2010 and found here:

This letter is more specifically related to the way CH was marketing their products. The important quote is here: “The therapeutic claims on your web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease”

Whatever has happened since, Cerebral Health does appear to still be in business, thankfully. I certainly hope that they’re able to come into compliance with FDA guidelines, because Cerebral Health is a very important supplier in our little Nootropic pond. I have emailed Cerebral Health letting them know that we’re rooting for them and asked for an update. If I receive one, I’ll update all of you.

Update 5/1/2012: Cerebral Health has passed its second FDA inspection with flying colors.

Update 2/1/2014: Cerebral Health has been sending out mislabelled products.


  1. Kleuf   •  

    Have you gotten any kind of update yet?

    I got here because I ordered bulk Pyritinol which doesn’t match the chemical properties of how it’s described in any source.

    It’s fat-soluble instead of water-soluble, and the color isn’t pure white but a little off-white instead.

    Next to two rather old forum threads relating to this same issue, I couldn’t find any other source explaining this deviation.

    It really makes me doubt their integrity, which really sucks because they’re the only supplier of quite a few things. I’m also starting to wonder the purity of the other nootropics I ordered at them :-/

    I’m dying to know what’s going on over there..

    • mike   •     Author

      Unfortunately I have not heard back from CH. There haven’t been any other FDA warnings or notices out about them. If the chemical properties are off then it sounds like you didn’t receive pyritinol.

  2. Antony Guglielmone   •  

    Hey, not a regular user of the site, but in regards to pyritinol, the solubility in water varies greatly with temperature and probably is not attributable to CH. While CH may not have done testing, I myself have obtained IR spectra for a few products without anything unusual. Didn’t get to do GC, but as far as nootropic suppliers go, CH is one of the lesser evils I have encountered 🙂

  3. Douglas Phillips   •  

    I am the Director of R&D at CH and we just went through a 2nd FDA inspection. We received no violations this time.

  4. Pingback: CerebralHealth Passes FDA Inspection | Smarter Nootropics

  5. John   •  

    FDA is only part of the issue with this company!!!
    The real issue is they are liars and scammers!!
    I’ve placed an order over a month ago, they have received my money and I’ve received no correspondence and no product!

  6. Brad   •  

    I’ve bought from CH a couple of times and received exactly what i bought.

    The FDA creates drama to keep there slithery little jobs, because in a real world situation, they’d be drawing unemployment.

    and i’ve also come to realize that trouble with the FDA, often times means you are selling something successful and you have lots of customers.

    So quit shaking and buy what you want

  7. anon   •  

    EVERYONE NEEDS TO BE AWARE THAT THERE HAS BEEN A CASE WHERE PYRITINOL FROM CH HAS BEEN SENT IN FOR TESTING AND WAS FOUND TO BE DIPHENHYDRAMINE. IT ALMOST KILLED SOMEONE. I have ordered from CH before with no problems but because someone almost died this needs to be addressed. They do no GCMS testing on their products.

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