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: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm257770.htm
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: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm198452.htm
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. http://www.reddit.com/r/Nootropics/comments/1mmip9/cerebral_health_pyritinol_test_results_warning/