Mycotoxin Binding Claims

Recently, several firms have made mycotoxin binding claims on products traditionally used as anticaking agents. This CVM update reiterates the Agency’s established position on the marketing of these products.The use of sodium aluminosilicate and hydrated sodium calcium aluminosilicate as binders for mycotoxins is not considered to be generally recognized as safe (GRAS).

Products intended to be used for or promoted to bind mycotoxins and other harmful toxins are food additives under Section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act. They must be the subject of an approved food additive petition (FAP) if they are intended (sold) to be used for this purpose.

Sodium aluminosilicate and hydrated sodium calcium aluminosilicate are generally recognized as safe (GRAS) (21 Code of Federal Regulations Part 582.2727 and 582.2729) when used as anticaking agents in animal feed at a level not exceeding 2 percent in accordance with good manufacturing or feeding practices. However, FDA's Center for Veterinary Medicine (CVM) has consistently maintained that the use of sodium aluminosilicate or hydrated sodium calcium aluminosilicate as binders for mycotoxins is not GRAS and approved FAPs must be obtained before these products may be used or claims may be made regarding their utility as mycotoxin binders. Products which are not the subject of an approved FAP may be subject to regulatory action.

CVM is concerned that all mycotoxins are not uniformly bound by anticaking agents and that similar anticaking agents do not bind mycotoxins to the same degree. Furthermore, any mycotoxins which are bound might not remain bound when the feed is consumed and exposed to the acid environment of the gut. If this were to occur, the animal could be exposed to unknown and potentially unsafe levels of mycotoxin which could result in mycotoxin residues in meat, milk, or eggs.

Questions regarding this position may be directed to the Drug and Device Team (HFV-232), FDA/CVM Division of Compliance, 7500 Standish Place, HFV-232, Rockville, MD 20855, 301-594-1785.