Why a recall for mold, rather than a withdrawal?
I just read this in the weekly FDA alert email: "Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth". Is there something I am missing as far as regulations regarding mold? Mold is nasty, but not a pathogen, not on the list of major allergens, so why a recall, why wouldn't this just be a withdrawal?
Because it may have been distributed (to the end consumer) already. It is not a pathogen, but they found pieces of mold. We don't know what type and in what concentration. Some molds can be toxic. It is bad enough to recall.
It is something that shouldn't be in the product and might still be a risk to the consumer. Much like any foreign material in a way.
A withdrawal is usually for instances where the end product has not reached consumers. Example: The affected product was sent to a distribution center for Walmart, but is not yet in Walmart stores, when the mold was reported.
A recall is when the product has reached consumers. Going with the example: The affected product was on Walmart shelves by the time the mold was reported.
mold growth could be considered as filth or prepared under insanitary conditions. Some molds produce mycotoxins which can be dangerous.
(a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).