Finally! After 25 years, mycotoxin adsorbent has been approved in Texas

Since the first ever Mycotoxin Adsorbent (MA) research was done in 1987 by Dr Timothy Phillips, one of the main objectives has been to be able to make the claim of MA in the USA.   

Until now MA's have been sold in the USA but as anti-caking agents (clays) or as feed supplements (yeast, bacteria, enzymes) or their combinations. Claims of MA are not made on the label, but most of the products are marketed to the end user by providing data against mycotoxins showing improvements in productivity and/or immune parameters which are secondary / side effects caused by the presence of the mycotoxin and can be influenced by a variety of factors and / or ingredients.

From the first published research on MA (Poult Sci 1988. 67:243-247), it is known that the key scientific evidence of the effectiveness of MA is: Target Organ Protection (TOP) since each mycotoxin has a specific target organ (Aflatoxin - Liver, Ochratoxin - Kidney, etc.)      

Special Nutrients with 25 years of experience in this field has never sold any product in the USA market even as an anti-caking agent. We have waited for government regulations to be able to make the claim of a mycotoxin adsorbent since all our in vivo trials conducted with our products against different mycotoxins have TOP results and the majority of them have been published in reputable Poultry Science or Animal Science Journals. 

On Feb 11^th 2011, the state of Texas published the provisions for the use of Aflatoxin Binding Agents and on May 10^th the Criteria for Aflatoxin Binding Agents. Part of the criteria requirements are to present Isothermal Adsorption Analysis that gives a Qmax value which is an in vitro study and in vivo studies on the efficacy of the product.  

Special Nutrients, Inc. as of September 5, 2011 was granted the license 109037-2 to sell and distribute MYCO-AD as a Natural Aflatoxin Binder in the State of Texas.  As part of the requirements we presented several in vivo studies in Poultry, Cattle and Swine all with TOP results.   

The first country to legislate scientifically MA was Brazil. In 2005 the requirements for approval of Anti Mycotoxin

Additives (AMA) were issued.  The key for this approval is to have statistical significance on TOP per mycotoxin per species. One of the main institutes in charge of conducting trials for approval of AMA has been LAMIC, (www.lamic.ufsm.br/aameng/index.html). Since 2005 until today they have tested 162 products but only 62 (38%) have shown TOP results (35 Aflatoxin, 17 Fumonisin, 10 Zearalenone). The majority of approved products are clay based.  Special Nutrients has a total of 6 approvals by LAMIC.  In January 2011 MYCO-AD became the only product approved with TOP results in poultry, swine and dairy.

In Europe one of the first attempts to register a product to control mycotoxins was made in 2005, that it was for a bacteria based product. You can review the opinion of EFSA here. 

In 2009 the EU Commission passed regulation No 386/2009 opening a new functional group of feed additives to control mycotoxins, but the parameters of how to approve products are still in discussion. A dossier has been submitted for a Bentonite. EFSA has given an opinion (not an approval) that this particular Bentonite is only good for Aflatoxin control in ruminants. 

In this opinion EFSA recommends that since Bentonites can show a wide range of binding (there are not two bentonites and/or clays alike) that a minimum in vitro binding capacity equivalent to 100 mg AfB1/g should be required for a product.

Looking at the above events of approvals /opinions of MA it is clear that clays (not yeast, bacteria, enzymes, etc) are the key ingredient when it comes to MA. Also and much more important is that not all clays are equal, as a matter of fact there are not two clays alike. Because of this a true MA must have TOP results per mycotoxin per species since products can work in one specie and not in another.           

MYCO-AD with its Brazilian and Texas (USA) approvals has become the first and only MA to be approved by 2 governments in poultry, swine and dairy with TOP results.