Ding, ding, ding we have a winner. This is the same FDA that stopped ethanol producers from making hand sanitizer, at the behest of the purell of course[0]. The feds have done practically nothing for the States making them compete each other for ppe and also confiscated shipments [1] while saying the national stock pile isn't for the States [2]. At this point I hope they just ignore the feds. We might be better off revisiting the articles of confederation at this point.
> In one case, the FDA said it had found significant levels of the carcinogen acetaldehyde in ethanol supplied by a company for use in hand sanitizer, according to a recent email exchange seen by Reuters.
Is anyone surprised that using fuel ethanol might not be a good idea for hand sanitizer?
They also stopped distilleries from doing so. Unless the argument there is "you can ingest alcohol made in this facility, but not put it on your skin"...
> Acetaldehyde occurs naturally in coffee, bread, and ripe fruit,[10] and is produced by plants. It is also produced by the partial oxidation of ethanol by the liver enzyme alcohol dehydrogenase
Doesn't really sound like a problem in a topical solution like hand sanitizer given people ingest it regularly.
I don't see any explicit guidance on Acetaldehyde. The requirements show 95% ethanol for ethanol-based sanitizer, with a footnote saying actually, "Lower ethanol content alcohol falls within this policy so long as it is labeled accordingly, and the finished hand sanitizer meets the ethanol concentration of 80%."
It goes on to add, "Ethanol produced in facilities normally producing fuel or technical grade may be
considered for use if the ethanol is produced from fermentation and distillation as would
be typically used for consumable goods, and no other additives or other chemicals have
been added to the ethanol. ... Because of the potential for the presence of potentially harmful
impurities due to the processing approach, fuel or technical grade ethanol should only be
used if it meets USP or FCC grade requirements and the ethanol has been screened for
any other potentially harmful impurities not specified in the USP or FCC requirements."
Edit2: Here's the USP guidance on hand sanitizer, which lists Not More Than 10uL/L Acetaldehyde / Ethanol:
https://www.usp.org/sites/default/files/usp/document/health-... Again, it's an ordinary metabolite of ethanol in the body, so this is probably pretty conservative.
Wikipedia notes, "After intravenous injection, the half-life in the blood is approximately 90 seconds." https://en.wikipedia.org/wiki/Acetaldehyde#Exposure_limits and "According to European Commission's Scientific Committee on Consumer Safety's (SCCS) "Opinion on Acetaldehyde" (2012) the cosmetic products special risk limit is 5 mg/l."
Ethanol-based sanitizers can be ingested by desperate people. I know what binge can do. These in need found a way to drink denatured alcohol [1], doing very little to clean it up.
So, please add a point to your discourse. In my opinion, FDA did more good than bad for population of US in that particular case.
There are many, many products approved by the FDA that can be abused by "desperate people". Given the limitations on sale, demand, and other things that would appear to be a lesser evil. I'd definitely disagree with the conclusion that preventing this "did more good for the population of the US". Even more so given that many of these facilities were mainly doing "personal" size efforts, 10-15ml bottles. Even at 96% alcohol (which is what the distillery here was getting), 10ml of alcohol won't put much of a dent in the alcoholic who is debating drinking hand sanitizer. It's barely a shot of vodka.
I'm not sure why this comment is downvoted -- it's definitely true, and the FDA does care about stuff that people ingest even if they aren't supposed to.
> In one case, the FDA said it had found significant levels of the carcinogen acetaldehyde in ethanol supplied by a company for use in hand sanitizer, according to a recent email exchange seen by Reuters.
Is anyone surprised that using fuel ethanol might not be a good idea for hand sanitizer?