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Hungarian Midget Woman
  
Location: Midwest | Tuesday, November 4, 2014 Print
FDA: Equine Ulcer Product Marketing Leads to Warnings for Horse Companies
stock photo by RMHP Staff, The U.S. Food and Drug Administration sent warning letters to equine companies who are allegedly marketing their horse ulcer products without federal approval. The FDA sent warning letters to three Florida based companies: Horse Gold, Inc., Horse PreRace, and Tri-Star Equine Marketing. The companies are accused by the government agency of marketing gastric ulcer products as "intended for the use in the mitigation, treatment, or prevention of disease in animals," which under the law makes their products a drug. The warning letters state "to be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing..." The FDA states the companies' drugs are considered unsafe and adulterated. HorseGold, Inc. markets the product GastroMax3. Click here to read the company's warning letter. Horse PreRace markets several products including Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, Gastromax3, Flunixin, Synedem, Toltrazuril Paste, and Super Tie Up. Click here to read the warning letter. Tri-Star Equine Marketing promotes the product Gastrotec.Click here to read the company's warning letter. The companies have 15 days to respond to the FDA regarding their compliance.
Edited by barrelracr131 2014-11-05 10:32 AM
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Hungarian Midget Woman
Location: Midwest | In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) ETA: Should have said "generic compunded omneprazole", not UG/GG
Edited by barrelracr131 2014-11-05 11:02 AM
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 Tough Patooty
Posts: 2615
Location: Sperry, OK | Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue? |
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Hungarian Midget Woman
Location: Midwest | ACEINTHEHOLE - 2014-11-05 10:42 AM Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue?
His would perhaps be exempt because it is a powder, but I'm not 100% sure. |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | barrelracr131 - 2014-11-05 10:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell)
These companies aren't actually selling Ulcergard/Gastrogard. They are selling Omeprozole (and others like it), but the hang up is the claims they make to treat/cure/prevent ulcers. This is where they get in trouble. The mechanism that allows Ulcergard/Gastrogard to make it past the acid in the stomach, to get absorbed to be able to shut down the proton pumps that produce the acid is patented by Merial. To get that patent and FDA approval, Merial had to go through years of testing and millions of dollars for testing... These other products don't use the same mechanism and have not gone through the testing to get approval from the FDA, so therfore, they can not make the claim on the label they are making and it be legal.
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Tough Patooty
Posts: 2615
Location: Sperry, OK | barrelracr131 - 2014-11-05 10:46 AM ACEINTHEHOLE - 2014-11-05 10:42 AM Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue? His would perhaps be exempt because it is a powder, but I'm not 100% sure.
Edited by ACEINTHEHOLE 2014-11-05 10:54 AM
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 Extreme Veteran
Posts: 554
| Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.  |
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Extreme Veteran
Posts: 330
| barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell)
That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/ |
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Hungarian Midget Woman
Location: Midwest | ACEINTHEHOLE - 2014-11-05 10:52 AM barrelracr131 - 2014-11-05 10:46 AM ACEINTHEHOLE - 2014-11-05 10:42 AM Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue? His would perhaps be exempt because it is a powder, but I'm not 100% sure.
My guess is the difference between GG/UG is in the manufacturing procedures. For it to be FDA approved, the manufacturing process is part of the approval, as well as certain quality control measures.
I'm guessing they started selling the Ulcerguard as a cheaper alternative once they found a cheaper way to make the product. If they change anything during the manufacturing process, they would have to redo all of the clinical trials and research. (way too expensive).
I'm only familiar with FDA approval in a medical test context so I could be wrong about some specifics. |
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Hungarian Midget Woman
Location: Midwest | SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/
Yes, you are correct- that should say "generic omneprazole", not the specific product name.
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. |
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Hungarian Midget Woman
Location: Midwest | rowdy256 - 2014-11-05 10:55 AM Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.
Or LRQHs will have locked him up in her basement |
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 Elite Veteran
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Location: Texas! | They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval. |
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Extreme Veteran
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| WYOracer - 2014-11-05 12:07 PM
They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval.
Yes. |
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Extreme Veteran
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| barrelracr131 - 2014-11-05 11:02 AM
rowdy256 - 2014-11-05 10:55 AM Oh don't worry he will be in prison soon, and I bet the FDA won't be able to find him.
Good one, or locked in her barn! |
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Extreme Veteran
Posts: 330
| barrelracr131 - 2014-11-05 12:01 PM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future.
What we also don't know, is if the delivery is effective with the other pastes like it is with UlcerGard and GastroGard.
If these generics do not have a buffering ingredient to prevent degradation of the omeprazole in the stomach, it doesn't really matter how much or little omeprazole is in the tube if it doesn't reach its desired location to start working properly. |
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Location: Somewhere between S@%&# stirrer and Saint | ACEINTHEHOLE - 2014-11-05 10:42 AM Douglas J Gordon, does this type of FDA crackdown affect you? I know you are not listed in this particular group, but does your product get affected by this type of issue? Yes, I will comment later. Where was the FDA when SUPERIORBUTE POWDER was being produced and all the illegal compounders were out there mass producing?
Edited by Douglas J Gordon 2014-11-05 11:14 AM
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Hungarian Midget Woman
Location: Midwest | SuckerForHorses - 2014-11-05 11:10 AM WYOracer - 2014-11-05 12:07 PM They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval. Yes.
Correct- so I am questioning how they will be able to continue to sell this product in the future... |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | barrelracr131 - 2014-11-05 11:01 AM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future.
You can't have a "generic ulcergard" when the patend on Ulcergard has not expired. And you, by law, can not prescribe a drug for off label use when there is a drug on the market for that specific use. Years ago when vets prescribed all the human pills for ulcers, pepto type stuff for ulcers, etc.. they could do that legally since there was not an FDA approved drug on the market specifically for ulcers. Now that Ulcergard/Gastrogard is on the market, it is ILLEGAL for vets to prescribe human/dog approved opmeprozole (or any other one out there) for use in horses. I know they do it, but if they were to get caught, it would for sure be a hefty fine and possibly their license.
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Hungarian Midget Woman
Location: Midwest | SuckerForHorses - 2014-11-05 11:12 AM barrelracr131 - 2014-11-05 12:01 PM SuckerForHorses - 2014-11-05 10:56 AM barrelracr131 - 2014-11-05 11:40 AM In other words, the FDA is trying to stop these companies from selling Ulcerguard/Gastrogard (from what I can tell) That's not what the letter says at all. It has NOTHING to do with Merial's UlcerGard or GastroGard.
The warning is because the products they are selling aren't FDA approved for the use that they are marketing them for. Also, an interesting note:
Further, the letter to Jones stated that the FDA had obtained samples of the company’s Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product’s label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/
and you are correct on the lowered efficacy... however, the costs between the two products are VASTLY different.
I realize much of the hoopla is based upon the "claims" made by the companies, but I mostly wanted to warn people that these products mentioned might not be available in the future. What we also don't know, is if the delivery is effective with the other pastes like it is with UlcerGard and GastroGard.
If these generics do not have a buffering ingredient to prevent degradation of the omeprazole in the stomach, it doesn't really matter how much or little omeprazole is in the tube if it doesn't reach its desired location to start working properly.
Agree-
Honestly I'm not sure of the buffers in these various products. |
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Tough Patooty
Posts: 2615
Location: Sperry, OK | barrelracr131 - 2014-11-05 11:13 AM SuckerForHorses - 2014-11-05 11:10 AM WYOracer - 2014-11-05 12:07 PM They are in trouble for the claims of preventing or treating ulcers is the way I read it. That's what makes it a "drug" and the need for FDA approval. Yes.
By law, they can't.. that is the issue and why they are cracking down.. all this per Merial's request btw.. I have a good friend that is a rep for them, they report these companies daily! |
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