Comment · Fri, October 4, 2013 · Ceretropic
Cerebral Health Pyritinol Test Results (WARNING)
Original post in this thread
MisterYouAreSoDumb · 491 points
Many of you may remember the issue that came up with Cerebral Health/Bioscience Nutraceuticals a few months ago, where their choline bitartrate was numbing people's mouths. After sending those samples in to the lab, the tests came back negative for choline bitartrate. We suspected it was choline salacylate, but decided further testing to ascertain the exact compound would not be worth the cost. Unfortunately that was not the last issue to come from Cerebral Health.
A few weeks ago, another Redditor placed an order pyritinol from CH, along with some alpha GPC and oxiracetam. When the order arrived, both the alpha GPC and oxiracetam seemed alright. However, the pyritinol seemed off. Before thinking about it, he took his normal 400mg dose of pyritinol and went out for a mountain bike ride. Within 15-20 minutes he was getting a weird euphoria and detachment. After another couple minutes, his memory gets very fuzzy.
Eventually his sister found him in the garage in a manic/psychotic state. He was biting his lips very hard, shaking, and holding his fists tight. Eventually he went into seizures when the paramedics came. He was taken to the hospital and seized again while waiting for th…
What they were answering
Stilbon77 · 2 points
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm257770.htm
Thought this was of interest. Maybe things haven't changed much. FDA
"Your significant violations include the following:
1. You failed to prepare and follow a written master manufacturing record for each unique formulation and batch size of dietary supplements that you manufacture to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a). Specifically, you verbally confirmed to our investigator that your firm does not have written master manufacturing records for any of your dietary supplements.
2. You failed to establish product specifications for the identity, purity, strength, and composition of each finished batch of your finished dietary supplement products as required by 21 CFR 111.70(e). Specifically, you verbally confirmed to our investigator that your firm has not established product specifications for any of your finished dietary supplement products.
3. You failed to establish identity specifications for each component used in the manufacture of your dietary supplement products as required by 21 CFR 111.70(b)(1). Specifically, you verbally confirmed to our investigator that your firm has not established identity specifications for any dietary ingredient components used in the manufacture of your finished dietary supplement products.
4. You failed to e…
u/MisterYouAreSoDumb · Ceretropic
Thanks! We've known about that issue for a while. I am actually discussing it indirectly on Longecity right now.