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Old 11-20-2021, 04:05 PM
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bcredliner bcredliner is offline
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Quote:
Originally Posted by crystalworks View Post
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."
The FDA didn't say that because that was not not what happened. The FDA concessions were always temporary. That's the key word. That is not an indication the FDA made a mistake or that sanitizers with the alcohol content the FDA temporarily approved were harmful to users.

If you read the new update companies are able to continue selling until March 2022, though have to stop production Dec 31, 2021.
OK, My guess is that the demand remained larger than the supply. Nothing bad about that as the temp level of alcohol was not dangerous to humans.

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
https://emergency.cdc.gov/agent/benzene/basics/facts.asp. Valisure is a group of pharmacies not of the capability of the FDA. The key to the potential effects of benzines is how much contact it takes to cause any problems. on humans. That is not considered in the petition and though not a lawyer I see it as frivolous petition probably designed to get into the news with the goal to improve business. The Valisure link is a petition not a suit.

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?
You are referencing the second consumer warning. The first was 8/20/20. https://www.goodhousekeeping.com/hea...s-coronavirus/

Here is a link to the temporary policies: https://www.fda.gov/media/136289/download
I don't see how this link supports your position

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.
I don't know if or what problems the FDA has. I have not said FDA is flawless. What agencies are you suggesting have more credibility than the FDA?

Stay safe all.
The new products were tested by the FDA and those not meeting the requirements were recalled from the market and a public notice was released. That began on August of 2020. Who has filed the lawsuits?
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