FDA Issues Warning Letters to Three Makers of Horse ‘Supplements’
http://www.paulickreport.com/news/the-biz/fda-issues-warning-letters-to-horse-supplement-companies/
Good to see these shady businesses dealt with! I know a lot of people here purchase from HorsePreRace.
Thanks for posting.
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.
Interesting.
[QUOTE=SuckerForHorses;7841523]
Interesting.[/QUOTE]
Yes, an overall concern with supplements vs. FDA regulated medications. Supps are not monitored and do not have to adhere to the strict regulations that FDA approved substances do. The label claims what it claims, and you have to just trust the label unless you feel like sending the contents off for independent testing. This goes for vitamins, nutraceuticals, etc.
[QUOTE=Flash44;7841847]
Yes, an overall concern with supplements vs. FDA regulated medications. Supps are not monitored and do not have to adhere to the strict regulations that FDA approved substances do. The label claims what it claims, and you have to just trust the label unless you feel like sending the contents off for independent testing. This goes for vitamins, nutraceuticals, etc.[/QUOTE]
Yes, I know.
There are always posters on here who are the voice of reason who say that these un-regulated drugs can have this exact issue (the unknown amounts of ingredients, etc) so I find it interesting that when tested, this product had that same issue discovered.
I think it’s a good thing to regulate from a quality control standpoint… however, I for one do not want to be limited to only $30/tube GastroGard again when it comes to needing omeprazole…
I understand where you’re coming from Tex but that horse Prerace company is very shady. I wouldn’t be at all surprised if the amount of the drug is the least of the problems with them.
The stuff is made in Panama with zero safety controls or quality oversite. Isn’t that scary enough for you? Never mind their physical address was discovered to be an abandoned building in FL a few years ago. I’m all for saving money but refuse to take chances like this with their health.
I doesn’t surprise me at all that Horse PreRace was busted because they ARE shady and breaking the law. But the way I see it, the risk is low with omeprazole as compared to some of the other stuff they advertise. I couldn’t imagine using their injectables-- waaaay too risky. Nor would I use something like their anti-protozoals, as under-dosing them could have serious health risks. But with an oral paste that I use mainly for analgesic effects on the stomach, the risks are minimal, with the biggest risk being it doesn’t work.
I’ve bought Gastromax paste from Big Dee before and had no problems with it. That is what I’m most irritated about. We horse owners get an affordable, legal option for omeprazole, and it may be taken away.
The Gastrotec with misoprostol-- now that DOES terrify the crap out of me. I can’t believe that was being sold over the counter for horses. Misoprostol is such a highly monitored drug in the human world. It has some serious side effects…
Except it’s not an affordable, legal option for omeprazole. It’s an affordable, illegal option for omeprazole. I for one would rather spend a little more money and know that my horse is getting what the label says she’s geting.
[QUOTE=hj0519;7847376]
Except it’s not an affordable, legal option for omeprazole. It’s an affordable, illegal option for omeprazole. I for one would rather spend a little more money and know that my horse is getting what the label says she’s geting.[/QUOTE]
The only thing illegal about the GastroMax3 is the packaging and trying to get around the FDA regulations, per the FDA. The company marketed it to treat and prevent a disease, gastric ulcers. By claiming to do that without FDA approval, they broke the law. With different wording, there may have not been an issue.
Also, there was no mention of the GastroMax3 not having what the label claimed. It was only the Horse PreRace omeprazole that tested below advertised amounts.
Posted on Rate My Horse Pro, three more companies have been sent warning letters. The article says “Specifically, the drug was found to be super-potent at 111.3% of the label claim.” I believe that was for the omeprazole paste product they sell.
[QUOTE=gumshoe;7852883]
Posted on Rate My Horse Pro, three more companies have been sent warning letters. The article says “Specifically, the drug was found to be super-potent at 111.3% of the label claim.” I believe that was for the omeprazole paste product they sell.[/QUOTE]
Link:
http://www.ratemyhorsepro.com/news/fda-cracks-down-on-second-wave-of-equine-companies.aspx
There goes COTH’s beloved pop rocks!
[QUOTE=Texarkana;7847386]
The only thing illegal about the GastroMax3 is the packaging and trying to get around the FDA regulations, per the FDA. The company marketed it to treat and prevent a disease, gastric ulcers. By claiming to do that without FDA approval, they broke the law. With different wording, there may have not been an issue.
Also, there was no mention of the GastroMax3 not having what the label claimed. It was only the Horse PreRace omeprazole that tested below advertised amounts.[/QUOTE]
But that’s the point. It is illegal for someone to sell omeprazole without going through the FDA approval.
With different wording it still would have be illegal. Omeprazole is not a supplement, it is a drug, so subject to laws about selling a drug.
I know it’s frustrating to have to pay high prices for approved drugs, but without the system, nobody would go through the approval process. Then you end up with all kinds of untested products or no products at all…
[QUOTE=foggybok;7852922]
But that’s the point. It is illegal for someone to sell omeprazole without going through the FDA approval.
With different wording it still would have be illegal. Omeprazole is not a supplement, it is a drug, so subject to laws about selling a drug.
I know it’s frustrating to have to pay high prices for approved drugs, but without the system, nobody would go through the approval process. Then you end up with all kinds of untested products or no products at all…[/QUOTE]
I may have misunderstood the regulations, but are all omeprazole-containing products subject to FDA regulation, or just certain dosages?
I was under the impression a product could contain omeprazole without approval so long as it wasn’t at therapeutic dosages or marketed as the FDA’s definition of a “drug.”
For example, you can sell bulk acetylsalicylic acid in whatever quantity you want. But as soon as you stick a label on it that says “take 300 mg for pain” you have turned it into a drug and thus need FDA approval.
I wish I had followed this thread–then I would have realized Abler was next. Glad to see their drug % was close to as advertised. I wonder if it is too late to stock up?
I have some on a truck that is out for delivery right now. 
I’m really not sure how the law around this topic works. (I’m not in the U.S.) I would assume that the drug would have to comply with what ever legislation exists where it is manufactured. If a drug is manufactured elsewhere, how does it have to comply with U.S. laws? Wouldn’t the “crime” be bringing it into the U.S.?
[QUOTE=kcmel;7852971]
I wish I had followed this thread–then I would have realized Abler was next. Glad to see their drug % was close to as advertised. I wonder if it is too late to stock up?[/QUOTE]
[QUOTE=Texarkana;7852919]
Link:
http://www.ratemyhorsepro.com/news/fda-cracks-down-on-second-wave-of-equine-companies.aspx[/QUOTE]
Cox Veterinary Laboratory, Inc’s warning letter is regarding the marketing of the
product Gastroade Xtra. Additionally, testing of the product revealed it is also adulterated, according to the FDA. The company’s warning letter states the active ingredient, omeprazole, in Gastroade Xtra is sub-potent, at 36.3% of the label claim for potency.
36%?! Those jerks. COME ON. :mad:
I wonder if the compounding pharmacies are next?
A lot of the Cox Vet products have “too good to be true” label claims. I don’t believe anything that they claim for their bargain basement prices. I got pressured into trying their joint supplement for my mare and knew it didn’t contain half of what was on the label. I just hoped it didn’t contain anything that wasn’t on the label. They have glowing reviews for that product on the Big Dee’s website and I think a lot of the reviews are fake. I posted a negative review which never saw the light of day.
I actually have more faith in Abler and how their products are produced, but illegal is illegal. It would be nice to see Merial bring the price of Gastrogard/Ulcergard down to a more affordable level so that people don’t have to look at sub-standard products. The way that these products are advertised though I doubt that most owners had any idea that they were buying an unregulated and illegal product.
I hope compounding pharmacies are next. Lots of them that make products that they aren’t supposed to (comparable approved version available on the market), make large batches of product that isn’t for a specific client, have insufficient safety protocols and manufacturing practices, etc. My vet uses a lot of this stuff which bugs me.
Does anyone have pharmaceutical/FDA experience?
From what I understand from my years of working in medicine, research, and industry, the initial FDA approval process is very time consuming and very expensive, involving trials, testing, etc. I am not sure what the process entails for those trying to market a generic version of a drug that is already approved, but I thought it was mainly fees and paperwork.
And hopefully someone else can chime in here-- but didn’t Merial’s patent on Gastrogard expire? What is the patent status on Ulcergard?
Companies should be able to start manufacturing generics of Gastrogard, although those generics would still require a prescription if labeled for the 4.0 mg/kg dose of omeprazole. If and when Ulcergard’s patent expires, companies can begin selling OTC Ulcergard generics labeled for “preventative” doses at 1.0 mg/kg. All generics would still need to follow whatever the FDA regulations are to market such a product, but they should not need to go through the entire approval process unless they change the formulation somehow-- such as adding another active ingredient.
None of these companies would be at fault if they weren’t marketing their products “for the treatment of ulcers in equines.” If they were just selling omeprazole, they technically wouldn’t be breaking any laws… or at least that’s my understanding.
According to this document: http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm117173.pdf
GastroGard US Patent 5708017, Expiration April 4, 2015
