Quote:
Originally Posted by bcredliner
[COLOR="Blue"]Can't find it. Where in the link does it say FDA changed specifications because of problems with their original approval? I read it as a temporary measure only about alcohol when there was a shortage of sanitizers and stopped when there was adequate inventory.
|
Policy has not stopped as of yet. I'm not sure what language you are looking for? They aren't going to say specifically, "We are ending this policy because we allowed non-drug mfgs to produce alcohol based sanitizers and took their word that they would follow our quality and testing guidelines." Come on now. Links to the actual policy below. The FDA says:
"Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements."
If you read the new update companies are able to continue selling until March 2022, though have to stop production Dec 31, 2021.
These are non-drug producing companies that were given temporary license to produce cheap hand sanitizers at elevated pricing. What could go wrong?
Here is the study that prompted them to end the policy. The sanitizer I used was found to have the worst benzene contamination of all those tested.
https://www.valisure.com/wp-content/...izer-v4.14.pdf
On your original link they became aware of problems with methanol contamination somewhere around July 2020 but did not take action except to issue a press release because sanitizer was still in short supply.
A recommendation against specific sanitizers (and voluntary recall urging to mfg) containing benzene did not come until 10/4/2021. Only 8 days before the withdrawal of the temporary policies. Coincidence?
Here is a link to the temporary policies:
https://www.fda.gov/media/136289/download
There are a few lawsuits filed already. Hell, I should probably call an attorney myself.
You don't have to believe the FDA fucked up and that all the alphabet agencies are fallible. But they did and they are. This discussion on mandates has gone circular and this one on the FDA is in danger of doing so as well so I am withdrawing. Don't want another reinforcement plate bolt discussion.
Stay safe all.