HuT
Active Member
Has anyone used Abler products to treat their horses ulcer?
According to a letter which Popsdosh once quoted, they have been tested by the US Food and Drug agency and contain the right levels of omeprazole.
It is illegal to use them, but thousands do, and they work.
please dont miss quote what I drew attention to . That letter was about the legalities of using abler products and to do with regulators enforcement action against Abler as their products are not licenced full stop even within the countries they manufacture in , Dont twist it to suit your own agenda.
You referenced a letter from the US FDA to Abler demanding that they stop supplying to the US. In that reference, the FDA says that they had tested the drugs and that they fell within the accepted levels of active substance for a drug with a narrow therapeutic index.
Omeprazole does not even have a narrow therapeutic index. So the Abler product was tested by the US FDA and MORE THAN meets the standard required to be legally supplied in the US.
I've been much happier about telling people the product is a good one ever since you posted, paradoxically, because you post to put people off it.
It is illegal. No-one has ever been prosecuted in this country for using it. I know of vets who advise (quietly) their clients to buy it when they are uninsured for ulcers. It works.
ETA here's the original reference
https://forums-secure.horseandhound.co.uk/showthread.php?741215-Abler/page6&p=13439177#post13439177
So lets be very clear here ! You admit its ilegal to import into the UK! are you saying its legal to import into the US ?
Can you please tell me any country that it holds a Licence in? If not why dont they licence it? If you cant why is it ok to break veterinary medicines regulations ?
Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.I have always, always said that it's illegal.
It's illegal.
It meets all the required standards for a legal product.
Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.
I will put this up so others may be clear and I draw your attention to the second paragraph as maybe that should be read rather than cherry pick what was a breach and in its own way shows a lack of manufacturing competence. Maybe others view it differently ,not sure I would want to take a drug that was stronger than stated.
Mr. Lindsay Kotthoff
Abler, Inc.
P.O. Box 158
Corowa 2645 NSW Australia
Dear Mr. Kotthoff:
This letter concerns the marketing of several products including, but not limited to, AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen by your firm, Abler, Inc. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address abler.com, where you promote and sell this product, and obtained and tested samples of your AbGard product.
We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], because you are marketing them without approved new animal drug applications. In addition, the drug AbGard is adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351 (c)], as testing of the drug revealed that its strength differs from the strength stated on the label.
Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:
AbGard
" ... for treatment and prevention of equine ulcers ... "
Abprazole
" ... for treatment and prevention of equine ulcers ... "
Abprazole Plus
" ... for treatment and prevention of equine ulcers ... "
Abler Omeprazole
" ... for prevention and treatment of Equine Gastric Ulcers Syndrome ... "
AbButazone
" ... for the alleviation of inflammation and pain associated with musculoskeletal disorders in adult horses"
AblerOuant
" ... for treatment and prevention of equine worms and parasites . .. "
AbFen
" ... to treat parasites that can damage a horse's gastro-intestinal and respiratory tracts."
The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.
Because the above referenced products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, these products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
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 under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501 (a)(5) of the FD&C Act [21 U.S.C. § 351 (a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.
This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly connect the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.
Sincerely,
/S/
Eric Nelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine
This paragraph in that letter sounds dreadful, but actually it means that Abler's products were tested by the FDA and found to be spot on, except for omrazole. However, the measure given is still within the allowable range for a drug with a narrow therapeutic index. That means one which only works well at specific doses. Omeprazole is NOT an NTI drug and that dose variation is medically fine.
'In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.'
So very kindly, the FDA have told us all that all the Abler drugs are effective and safe.
Illegal.
Effective.
Safe.
The letter is several years old and Abler are still in business and, afaik, happily supplying customers in the US in spite of the FDA's threats.
Im not going to try and argue that the products are probably reasonably effective and safe, if illegal.
But you cannot claim they definitely are. The reason being this company has chosen to bypass the legislations put in place to ensure they are safe and effective. Very expensive systems to ensure consistency in both the active product and any impurities. So you cant be sure that whilst one batch is good the next meets those criteria. That is why companies like these can produce products cheaper.
You pay your money you take your chances. But at least be honest about it.
And BTW you havent always said it was illegal. I remember quite clearly you spouting off it was legal in the early days, until I and a few others kindly corrected you.
I think you have a short and very selective memory and I can clearly recall you arguing as only you can that it was not illegal to import drugs on the internet.I don't believe that I have ever said it was legal. Please correct me if you can find it and quote me. I've always known it was illegal and I would never, ever, say something was legal if it wasn't. Either your memory has failed you or mine has. I don't think, on this issue, that it's mine. I think the only person on this site who has ever suggested that it was legal is JillA, and you may be confusing her posts with mine.
This all started because you chose to mention my user name in support of your assumption ,where you twisted certain parts of that letter and I think thats pretty shabby behaviour at best and potentially plain inflammatory. If thats not the case why was I mentioned and I look forward to a plausible answer! Im not arguing with you as lifes to short just giving others the information to make up their own minds if its a risk they are prepared to take.
Im still waiting for an answer as to why my username was mentioned . Unless of course I am correct and you were fully aware of the reaction it would cause!
reallyBecause you posted the link!
Interesting what leads you to make the above statement about standards? Their products are unlicenced or tested so how can you know.
really
They aren't untested. As the letter that the FDA sent to Abler shows, the FDA have kindly tested them for us. They found a discrepancy in omeprazole weight that was not clinically significant. They found nothing else wrong with any of the Abler products or that letter would have said so. I was very grateful to the FDA for confirming the safety of the products for us all, quite the reverse effect of what they were trying to achieve.
Your still spinning it nowhere in that letter does it state they are safe and effective !In fact it is the contrary. As I say others can judge seeing the letter.
There was only one product tested from Abler so please be clear about that .
Please just dont use my username in future to try and back up something you are spinning and is clearly a misinterpretation of what was written.
This paragraph in that letter sounds dreadful, but actually it means that Abler's products were tested by the FDA and found to be spot on, except for omrazole. However, the measure given is still within the allowable range for a drug with a narrow therapeutic index. That means one which only works well at specific doses. Omeprazole is NOT an NTI drug and that dose variation is medically fine.
'In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.'
So very kindly, the FDA have told us all that all the Abler drugs are effective and safe.
Illegal.
Effective.
Safe.
They aren't untested. As the letter that the FDA sent to Abler shows, the FDA have kindly tested them for us. They found a discrepancy in omeprazole weight that was not clinically significant. They found nothing else wrong with any of the Abler products or that letter would have said so. I was very grateful to the FDA for confirming the safety of the products for us all, quite the reverse effect of what they were trying to achieve.
See the problem is you obviously cannot see why the letters where sent and it wasnt just Abler.You think they only tested one product to see if they could catch them out? They only reported the one because they could only find a problem with the one. And that was a non-clinical issue.
PD omeprazole is omeprazole. The safety and efficacy of omeprazole in horses has already been fully tested. If the product contains nothing but omeprazole and the enteric coating, which it does because otherwise the FDA would have said it was contaminated, then it's safe.
Yes, it's illegal. Thousands of people are using it. Vets are even recommending it. It's an over the counter medication in small doses, freely available on eBay in large doses. There does not appear to be any attempt by the authorities in the UK to prevent Abler from selling here. The US tried four years ago to prevent them from selling into the US and have failed.
I'm not sure how far you think you are going to get with your one man crusade in the face of an overwhelming tide of happy customers.
Yes you can buy omeprazole online and also from the same seller as the equine one however many of them are unlicenced as well maybe you would not be so quick shoving them down your own throat.
They just resend if you don't receive what you order .