Norovirus

[sippican]

1 hour ago, ShipWalker said:

Because this thread is about Norovirus, not COVID-19.

 

And the top personal prevention to disease (and spreading) is still relevant - properly wash your hands.

 

As if we don't have enough threads without viruses without resurrecting a dead one! (And yes, I know it's about noro).

[D C]

3 hours ago, Fouremco said:

That's not accurate, as the FDA found that the claims for Zylast being effective were unproven and that there wasn't adequate evidence that it prevents infection. From the FDA's news release announcing that they were seeking a permanent injunction:

 

"Despite being warned by the FDA about their unproven claims, this company has continued to market their products as a tool for preventing infection from serious disease-related pathogens, without adequate evidence to support these uses," said FDA Commissioner Scott Gottlieb, M.D.

 

 

Again, not accurate. From an FDA Warning Letter date June 30, 2015 to Innovative Biodefense, the manufacturer of Zylast:

 

 

The following labeling claim was included on your website, www.zylastdirect.com:

 

• "The active ingredient in Zylast, BZT ... and is considered safe and effective in concentrations of 0.1-0.2% by the FDA."

 

FDA has not established nor proposed BZT (benzethonium chloride) to be safe and effective at any concentration when used as a leave-on antiseptic such as Zylast XP Antiseptic Lotion. Thus, this claim is false and misleading...

My statements are 100% accurate. 

 

The FDA is not saying the product does not work.  The FDA is saying "you are making claims about a substance killing germs. Germ-killing substances are 'drugs', and drugs are our department.  We don't care if your product does or does not do what you claim. It might do everything you claim. We omly care that you have not proven to US that those claims are factual. "

 

Do you think that Purell is snake-oil, too, or does it kill germs? Because the FDA has said nearly the exact same thing to them just last month. 

 

 

 

[Fouremco]

29 minutes ago, D C said:

My statements are 100% accurate. 

 

The FDA is not saying the product does not work.  The FDA is saying "you are making claims about a substance killing germs. Germ-killing substances are 'drugs', and drugs are our department.  We don't care if your product does or does not do what you claim. It might do everything you claim. We omly care that you have not proven to US that those claims are factual. "

 

Do you think that Purell is snake-oil, too, or does it kill germs? Because the FDA has said nearly the exact same thing to them just last month. 

 

 

 

Suit yourself. The FDA clearly states that the effectiveness of Zylast hasn't been established, but if you choose think otherwise, I'm not about to argue the point with you.

 

FYI:  the Department of Justice also filed suit against them, and they too state that that there is a lack of proof of its effectiveness.

 

According to the complaint, the defendants market various Zylast products as being effective against, among other things, infection by pathogens such as the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola virus, despite a lack of proof of the products’ safety and effectiveness for such uses and no approval from the U.S. Food and Drug Administration (FDA).

[D C]

1 hour ago, Fouremco said:

Suit yourself. The FDA clearly states that the effectiveness of Zylast hasn't been established, but if you choose think otherwise, I'm not about to argue the point with you.

 

FYI:  the Department of Justice also filed suit against them, and they too state that that there is a lack of proof of its effectiveness.

 

According to the complaint, the defendants market various Zylast products as being effective against, among other things, infection by pathogens such as the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola virus, despite a lack of proof of the products’ safety and effectiveness for such uses and no approval from the U.S. Food and Drug Administration (FDA).

 

Are you also maintaining that Purell does not kill 'germs' because the FDA lacks evidence that is suitable to them?

Because if you're claiming Zylast doesn't work because the FDA doesn't say that it does, then you must also hold the same opinion about Purell.

 

As I said before, the FDA really doesn't care if it works or not right now.  Even if it was the best product ever created for killing germs, the FDA would be taking the same position.   "You did not satisfy us, so even if your product works wonderfully, you can't make the claims you're making"

 

[UnorigionalName]

8 hours ago, D C said:

The FDA is not disputing the effectiveness. They're disagreeing with the labeling and claims being made. 

 

 

 

Zylast contains Benzethonium Chloride, which is effective in killing norovirus. That isn't being disputed. 

 

Can you point to me to an actual published study (not promotional material) that wasn't performed by a company selling BZT that shows its efficacy against noro? 

 

My i-don't-want-to-put-a-lot-of-effort-into-this search only found this one small paper showing it is not efficacious.

https://www.jstage.jst.go.jp/article/expanim/61/1/61_1_35/_article/-char/ja/

 

Anyways, it's a moot point as it is being banned by the FDA after april 2020.

https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers

[kearney]

The other thing is that while the chemicals may kill various viruses... how long do they have to be in contact to do the job... and quantity of chemical vs virus... might work on a counter top... but not work on your hands... why studies are important

[sippican]

1 hour ago, UnorigionalName said:

 

Can you point to me to an actual published study (not promotional material) that wasn't performed by a company selling BZT that shows its efficacy against noro? 

Anyways, it's a moot point as it is being banned by the FDA after april 2020.

https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers

 

Not sure where your linked article shows that it's going to be banned?  Is BZT different from benzalkonium?

The following quote seems to indocate otherwise:

At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.

[Globehoppers]

On 1/14/2019 at 1:51 PM, m8zenblue said:

I have been following the recent incident of Norovirus on Royal Caribbean and wanted to weigh in on the subject with some observations on Celebrity Cruise.

I am not a real cruise veteran, I have been on several.

I am amazed at the personal hygiene practices of guests.

There are hand sanitizing stations all over the ships, and especially at the restaurants with a crew member actually greeting guests and offering hand sanitizer.

I bet at least 35% of people decline the sanitizer.

Who knows where they have been or what they touched or handled.

I witnessed one guest on my last cruise actually put her hands on food disregarding the serving utensils.

We take all precautions when we cruise, we bring several containers of Clorox wipes, plenty of hand sanitizer, we disinfect the cabin and try to avoid touching things in public areas not without sanitizing hands.

I beg of you, to avoid sickness on a ship which could spread like wildfire, please be safe and use good hygiene, I would hate to be the one confined to my cabin for the duration of a cruise because of someone who does not wash or sanitize.

 

Good guidance.

 

Plus, DO NOT shake hands.

[Fouremco]

14 minutes ago, sippican said:

Is BZT different from benzalkonium?

Yes, there are two different substances mentioned in the article, benzethonium chloride and benzalkonium chloride. Easy to confuse, and both have similar properties. 

[UnorigionalName]

47 minutes ago, sippican said:

 

Not sure where your linked article shows that it's going to be banned?  Is BZT different from benzalkonium?

The following quote seems to indocate otherwise:

At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.

 

2. INELIGIBLE ACTIVE INGREDIENTS

The following list includes those active ingredients addressed in the 1994 TFM for use in antiseptic hand washes or healthcare personnel hand washes and identified in the 2016 Consumer Antiseptic Rub proposed rule as having inadequate evidence of eligibility for evaluation under the OTC Drug Review for use in an OTC consumer antiseptic rub:

• Benzethonium chloride
• ...

https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for

[D C]

2 hours ago, UnorigionalName said:

 

Can you point to me to an actual published study (not promotional material) that wasn't performed by a company selling BZT that shows its efficacy against noro? 

 

My i-don't-want-to-put-a-lot-of-effort-into-this search only found this one small paper showing it is not efficacious.

https://www.jstage.jst.go.jp/article/expanim/61/1/61_1_35/_article/-char/ja/

 

Anyways, it's a moot point as it is being banned by the FDA after april 2020.

https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-consumer-hand-sanitizers

Quick search, here's one: https://www.ncbi.nlm.nih.gov/pubmed/22897744

 

But it doesn't matter.  My point isn't that benzalkonium chloride works, it's that the FDA doesn't CARE if it works.  They care that they were not involved in the labeling. That's it. 

 

The assertion of others here is that if the FDA didn't say A-OK, then it is snake-oil, suggesting that it must NOT work unless the FDA approved it.    Yet Purell is in the same boat for making "unverified-by-the-FDA" claims in their labeling.  The FDA didn't explicitly approve those claims. 

[UnorigionalName]

2 minutes ago, D C said:

Quick search, here's one: https://www.ncbi.nlm.nih.gov/pubmed/22897744

 

But it doesn't matter.  My point isn't that benzalkonium chloride works, it's that the FDA doesn't CARE if it works.  They care that they were not involved in the labeling. That's it. 

 

The assertion of others here is that if the FDA didn't say A-OK, then it is snake-oil, suggesting that it must NOT work unless the FDA approved it.    Yet Purell is in the same boat for making "unverified-by-the-FDA" claims in their labeling.  The FDA didn't explicitly approve those claims. 

 

Sorry, benzalkonium chloride is not the same as Benzethonium chloride, not to mention the claim of extended "protection"

 

And, sorry, the FDA CARES A LOT if it works.  It just takes that regulating agency a long time to move.

 

again, from: https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for

 

"FDA has deferred further rulemaking on three active ingredients used in OTC consumer antiseptic rub products to allow for the development and submission to the record of new safety and effectiveness data for these ingredients...

 

 

 

this document describes the studies necessary as a scientific matter for the Agency to determine whether an active ingredient is GRAS/GRAE...

 

Requests were made that benzalkonium chloride, ethyl alcohol, and isopropyl alcohol be deferred from consideration in this consumer antiseptic rub document to allow more time for interested parties to complete necessary studies to fill the safety and effectiveness data gaps...

 

However, in the 2016 Consumer Antiseptic Rub proposed rule, we proposed to classify all three ingredients as Category IIISE for use in a consumer antiseptic rub because additional effectiveness and safety data are needed to classify each ingredient as GRAS/GRAE for this use...

 

FDA has deferred further rulemaking on these three active ingredients for use in OTC consumer antiseptic rubs to allow for the development and submission to the record of new safety and effectiveness...

 

D. Updated Statistical Analysis for Efficacy

..."

 

etc. etc. etc.

 

FDA cares a lot when you put on a bottle that something has a verifiable effect.  Yes, Purell is in a SIMILAR boat, but not the same because alcohol based got a stay of execution to provide the FDA with data that they are Safe and Effective.

 

so yes, my point:

1) The FDA cares a lot if you say your product can have a medical effect (prevent illness)

2) If you want to put that on the label, the FDA demands proof that it is true in order to put it on the label.

 

somewhat unrelated 3) I can't find good data showing BZT is effective against norovirus.

 

So yes, if the FDA doesn't let you put that your product is efficacious on your label (like airborne), it does suggest it is snake-oil.

 

I don't understand why you are so passionate about this topic...

[Fouremco]

11 hours ago, D C said:

Zylast contains Benzethonium Chloride, which is effective in killing norovirus. That isn't being disputed. 

 

14 minutes ago, D C said:

My point isn't that benzalkonium chloride works, it's that the FDA doesn't CARE if it works.

Well, which is it? Facts do matter. SMH