FDA warns Chewy kraft drug and fish antibiotics company

[jda]

This is just a guess, but if every vet wrote a Rx for a sick fish or coral, this would be a rounding error compared to the humans using the stuff.

 

[MnFish1]

This is just a guess, but if every vet wrote a Rx for a sick fish or coral, this would be a rounding error compared to the humans using the stuff.

Probably - unfortunately - it's a law. Beyond that - where are we? BTW - you're correct - since there a lot more people than fish. Percentage-wise not sure you're correct. This has been a long-standing issue - with poly-resistant bacteria - At least we're being consistent with the rest of the world (not that thats always the best plan)

 

[jda]

I looked pretty hard and asked a bunch of the right people and there are not any laws that restrict sales without a Rx for ornamental fish - only have to be labeled accurately. This could be changing.

If there are any, please let me know.

 

[MnFish1]

I looked pretty hard and asked a bunch of the right people and there are not any laws that restrict sales without a Rx for ornamental fish - only have to be labeled accurately. This could be changing.

If there are any, please let me know

Hope this helps: https://www.fda.gov/inspections-com...ons/warning-letters/chewy-inc-664707-11302023

of course at the end: "Within fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation."

 

[MnFish1]

I looked pretty hard and asked a bunch of the right people and there are not any laws that restrict sales without a Rx for ornamental fish - only have to be labeled accurately. This could be changing.

If there are any, please let me know.

PS - who are the 'right people'? I'd like to meet them

 

[MnFish1]

Curious - if this will also apply to praziquantel. @jda - I agree with you - its all in the wording - However my personal opinion is that there is a lot of antibiotic/antifungal use in the US for fish - apparently other countries agree.

 

[jda]

Did people read the FDA report? These are unregistered products. Some EM, prazi, metro, others are approved for use in ornamental fish - they can be resold without an Rx if they are labeled correctly... as in you can buy a batch of EM from an approved maker and repackage it to treat fish. If these pills came from an approved factory, then they likely will go through the approval process and get new labels but they won't likely be for aquarium fish - nobody needs 100 tablets of 500mg amox for an acute bacterial fish infection. I am sure that @Jay Hemdal knows the dosage, but isn't it like 5-10mg per 10 gallons? I am probably off, but not 50,000 milligrams (edited, said grams the first time).

These all also happen to be products that humans abuse - THIS IS WHERE THE FOCUS SHOULD BE. You see ChemiClean, Cyano Rx, Maracin (any of them), API EM, General Cure, etc. on this list? Some of them are legally marketed and sold and some are not, but they have so-far escaped this.

This is to stop selling fish pills to humans. It seems that the hobby is just an aside in this case. I know that if I type this 100,000 times, people will still confuse the two and some of it will likely be on purpose by some. Maybe avidhexagrammid will pop in for a bit.

I will reach out to one of my guys tomorrow. All government agencies have ways to contact them - all that you have to do is call and ask... they will not speak of pending litigation, which is sometimes a sign that there is litigation, but they will usually talk about just about anything else if you ask questions and listen. The same is true if you reach out to marine researchers, Scripps, etc. - most of them are nerds who enjoy talking to outsiders if you are respectful and nice and not looking to preach or complain to them.

 

[EeyoreIsMySpiritAnimal]

Did people read the FDA report? These are unregistered products. Some EM, prazi, metro, others are approved for use in ornamental fish - they can be resold without an Rx if they are labeled correctly... as in you can buy a batch of EM from an approved maker and repackage it to treat fish. If these pills came from an approved factory, then they likely will go through the approval process and get new labels but they won't likely be for aquarium fish - nobody needs 100 tablets of 500mg amox for an acute bacterial fish infection. I am sure that @Jay Hemdal knows the dosage, but isn't it like 5-10mg per 10 gallons? I am probably off, but not 50,000 grams.

These all also happen to be products that humans abuse - THIS IS WHERE THE FOCUS SHOULD BE. You see ChemiClean, Cyano Rx, Maracin (any of them), API EM, General Cure, etc. on this list? Some of them are legally marketed and sold and some are not, but they have so-far escaped this.

This is to stop selling fish pills to humans. It seems that the hobby is just an aside in this case. I know that if I type this 100,000 times, people will still confuse the two and some of it will likely be on purpose by some. Maybe avidhexagrammid will pop in for a bit.

I will reach out to one of my guys tomorrow. All government agencies have ways to contact them - all that you have to do is call and ask... they will not speak of pending litigation, which is sometimes a sign that there is litigation, but they will usually talk about just about anything else if you ask questions and listen. The same is true if you reach out to marine researchers, Scripps, etc. - most of them are nerds who enjoy talking to outsiders if you are respectful and nice and not looking to preach or complain to them.

Thank you for this!

 

[jda]

I might know more tomorrow, but the last time that I chatted, there was no intention to do anything about needing Rx for ornamental fish stuff - in the scale that ornamental fish might use - like a pack of Maracin which is like 100-200g, or so, which is not enough to really do too much with humans.

For our hobby, the emphasis was with companies that did not label their products... Boyd and the like. This all started as a offshoot when talking about UWC. I posted about this during the fallout of the UWC stuff.

For the outside world, it was bypassing human Rx by selling bottles of human drugs with fish on the cover.

My guess is that if all controlled products will need a Rx in the future is necessary to stop human abuse, it will happen - just like in most of the other parts of the world. If it does, this could take years and years outside of a state or federal executive order.

 

[jda]

Any Vets out there that hate their jobs need to start a online service that one I see on TV for Viagra, the stuff that regrows hair, etc. (Roman, I think - maybe Snoop Dogg can do commercials for you). There is a void of vets in the US that will even help people get Milbemycin Oxime to treat red bugs. Face Time for $50 and write an Rx if appropriate and ethical. Of course, I get 3% and free services for posting this idea.

 

[gbroadbridge]

Lol, NOT.

Fluconazole isn't an antibiotic!

It is used to treat human disease and should be regulated the same way if it is not already.

I recently had a close friend killed by a fungal infection that involved his heart, even after having a heart transplant he died.

Antifungals should not be used in an ornamental tank except on prescription by a veterinarian.

I'm so glad that the FDA is moving on this.

Use of these drugs is already restricted in most other countries

 

[MnFish1]

@jda - you can think what you want - and talk to whom you want - and though I agree with you in principle - I can't understand how you do not see the writing on the wall here - what are Europe/Canada and others doing on this issue. If you think the US is that far behind you're wrong. However - I agree with you - ONE of the main issues is people going to the pet store and buying these to treat a cough, etc etc (God knows why they would). Either way within a couple years - OTC/Over the internet antibiotics will be history IMHO - and according to my reading of the current state of affairs - including the FDA comments, this is not fantasy - but reality

 

[MnFish1]

This all started as a offshoot when talking about UWC. I posted about this during the fallout of the UWC stuff.

I don't think this has anything to do with UWC, nor do I think Canada and Europe have regulated OTC/Fish/Internet antibiotics due to UWC? I'm really curious - is it so bad if antibiotics are regulated?

 

[KrisReef]

As a member of "the healthcare complex" I would politely suggest that we are much more restricted by growing 'healthcare conglomerates" and the gigantic "pharmaceutical" businesses whose motivations are based 100% on profit. They now impact what we can and cannot do far more than government regulations because they are always one step ahead.

Government regulations were drafted into law to promote the conglomerates. "Visiting" a doctor is now required by law since you either can sign up for health care or get fined for not participating. As you pointed out, correctly, the administration of Health care is dictated by law and the doctors and patients must do as they are told.

When medical professionals get fined or lose their medical licenses for expressing a professional opinion on COVID-19 that is not in lock step with the CDC (as 1 example) then who is responsible for protecting the individuals rights for both doctors and patients who supposedly are allowed to freely seek medical services as they see fit?

I'm sorry, I'm not going to make any friends or win any lottery for posting about concepts like freedom and access to antibiotics for personal use in a world where only the licensed doctor can legally prescribe these compounds (in unlimited amounts) and a pharmacist is reported to be carefully comparing all patients medications to ensure that no possible complications occur.

If God were my pharmacist and the Holy Spirit were my doctor then I would trust them to deliver safe health care. The slogan comes right off the dollars that the government prints and the conglomerates extract from us while pretending to have our best interests at heart. It's a real mess, and it was nice to have access to pet medications when the pharmacist was closed over the Christmas holiday.

More to the point, how is it that Fentanyl is illegal but the streets are overrun with the stuff? Poison control, War on Drugs, how can the United States be so lopsided on goodness?

SOrry, I lost my mind for this post. I am not angry at anyone in particular, just frustrated with the quagmire created by our political class to enslave the rest of us.

Big healthcare is too big to not fail.

 

[MnFish1]

Government regulations were drafted into law to promote the conglomerates. "Visiting" a doctor is now required by law since you either can sign up for health care or get fined for not participating. As you pointed out, correctly, the administration of Health care is dictated by law and the doctors and patients must do as they are told.

When medical professionals get fined or lose their medical licenses for expressing a professional opinion on COVID-19 that is not in lock step with the CDC (as 1 example) then who is responsible for protecting the individuals rights for both doctors and patients who supposedly are allowed to freely seek medical services as they see fit?

I'm sorry, I'm not going to make any friends or win any lottery for posting about concepts like freedom and access to antibiotics for personal use in a world where only the licensed doctor can legally prescribe these compounds (in unlimited amounts) and a pharmacist is reported to be carefully comparing all patients medications to ensure that no possible complications occur.

If God were my pharmacist and the Holy Spirit were my doctor then I would trust them to deliver safe health care. The slogan comes right off the dollars that the government prints and the conglomerates extract from us while pretending to have our best interests at heart. It's a real mess, and it was nice to have access to pet medications when the pharmacist was closed over the Christmas holiday.

More to the point, how is it that Fentanyl is illegal but the streets are overrun with the stuff? Poison control, War on Drugs, how can the United States be so lopsided on goodness?

SOrry, I lost my mind for this post. I am not angry at anyone in particular, just frustrated with the quagmire created by our political class to enslave the rest of us.

Big healthcare is too big to not fail.

This is interesting - I think there a couple errors - There is no 'law' that one has to have healthcare or go to the doctor. But - IMHO - the difference is that, in reality no one should care what antibiotics you want to buy/use - EXCEPT - that those antibiotics may affect others. Unlike the Covid issue - which is going to be debated for decades, antibiotic resistance and misuse is not debatable IMHO

 

[jda]

My research and my sources have nearly a 100% documented track record on government stuff whether it be the NOAA thing, UWC or ChemiClean. Your track record is almost the opposite of this with either no sources, bad gut or hoping for a different outcome. What makes you think that I am wrong about this? Are these people now wrong? Did they get lucky with exact precision the last bunch of times?

I have no issue with needing an Rx for all of this... I don't need medications to run a reef at all, which is a small, selfish thing. The larger picture is that I also can see the points about ALL of the consequences. However, this is not what I have heard and discussed with people who have not been wrong yet. I see no compelling reason to not explain what I know even if I might hope differently.

On a different point, I just hate the argument that because something got out of control before that more should not be done now to keep it from happening again. I am OK with fish meds sold to humans being even a trial run to prevent the next fentanyl.

 

[Rubymoon286]

LOL YES - fluconazole is an anti fungal. And it falls under the same regulation as antibiotics. There is a Candida strain killing multiple people - which is pan-resistant to antifungals. So - Sorry - in this case you're incorrect - Sorry(

Oh hey, my field of research. I'm about to publish a paper on resistant murcormycosis cases in India co-morbid to Covid cases (only google if you have a strong stomach - it gets pretty brutal.) The C. Auris cases are equally horrific deaths from a medical standpoint. That said, I'm thankful for new restrictions on broad spectrum medications, not just from a treatment resistant stand point, but also public health for all the people who just run to tractor supply or petco to treat human illness with non regulated animal medications.

 

[A_Blind_Reefer]

Why an emergency?

It’s an emergency sale….Black Friday must have not panned out

 

[taricha]

It's not clear to me whether or not the letters (list of letters) address companies doing something different than what Seachem or Mars Fish Care (API) are doing.

It looks like the letters were sent to several vendors who distribute things from a few warned brands. The letters list products like "Fish Met" and "Aqua-Zole" but not Seachem Metroplex, and they list "Fish Ethro" but not API Erythromycin etc.

This might be very narrow, like @jda suggested. Maybe these are unapproved sellers manufacturers of the stuff, and approved sellers (bigger names we're more familiar with) are not in question.

I'd like to see an interpretation from someone with some legal knowledge here.

 

[taricha]

...What I mean is, it doesn't look to me like the letters are targeting general aquatic usages of erythromycin, or metronidazole, doxycycline etc. but are instead singling out a few select products of those meds?