FDA Draft Guidance for Mandatory Recalls
The FDA recently provided Draft Guidance for Industry regarding mandatory food recalls. The agency is asking for input on this document. Although this document is designed for industry, consumers can provide comments as well. Here is the comment sent from our pet food consumer association.
The following comment was provided to FDA on “Draft Guidance for Industry: Questions and Answers regarding mandatory food recalls”…
Association for Truth in Pet Food – representing pet food consumer members – provides FDA the following feedback on Draft Guidance for Industry: Questions and Answers regarding mandatory food recalls. Although this draft guidance is designed to inform industry to mandatory food recalls, consumers can benefit from knowing/understanding what conditions at a pet food facility would result in FDA action.
Quoting from FDA Draft Guidance Q&A document…
FDA states under question “2. What foods are subject to FDA’s mandatory food recall authority?”
“The term ‘food’ refers to (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article (section 201(f) of the FD&C Act [21 U.S.C. 321(f)]).”
It is clear, with this definition of food provided, that pet food would be included under FDA’s mandatory food recall authority. Pet food consumers thank FDA for including the legal definition of food which assures us pet food will be included under mandatory recall authority. However we do have some significant questions relating to Draft Guidance Q&A #7 along with existing FDA Compliance Policies.
FDA states: Draft Guidance Question & Answer #7…
“7. When is a food considered adulterated under Section 402 of the FD&C Act?”
“Section 402 of the FD&C Act includes many reasons a food may be adulterated including:
If the food bears or contains any poisonous or deleterious substance which may render it injurious to health; consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; or has been prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health;”
ATPF would like to point out to FDA another portion of the same section in the FD&C Act. Section 402 (C)(5) states…
“A food shall be deemed to be adulterated—”
“(C) if it is or if it bears or contains (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;”
Our questions concern FDA Compliance Policies which are in direct conflict with the FD&C Act Section 402.
FDA Compliance Policy CPG Sec. 675.400 Rendered Animal Feed Ingredients states “POLICY: No regulatory action will be considered for animal feed ingredients resulting from the ordinary rendering process of industry, including those using animals which have died otherwise than by slaughter, provided they are not otherwise in violation of the law.”
FDA Compliance Policy CPG Sec. 690.300 Canned Pet Food states
Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.”
If food is what animals consume (per FDA’s legal definition of food – pet food as example) and this same food (pet food) is considered adulterated per Section 402 (C)(5) of the FD&C Act if it would contain “material from diseased animals or animals which have died otherwise than by slaughter”, pet food consumers ask FDA will pet foods made from these materials be subject to a voluntary or mandatory recall? Or will FDA continue to enforce the Compliance Policies instead of the FD&C Act?
Quoting the Section 402 of the FD&C Act FDA included in this Draft Guidance document defining an adulterated food, “consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food”, ATPF has a difficult time understanding how an animal that had died in the field (otherwise than by slaughter) would not be considered putrid or decomposed substance when it is rendered days later becoming a pet food/animal feed ingredient? ATPF asks FDA how this source of pet food meat could be possibly considered fit for food?
On behalf of pet food consumers, ATPF asks FDA to clarify within recall guidance documents exactly what quality of ingredients will and/or will not be allowed into pet food. Pet food consumers should be informed if ingredients sourced from “diseased animals” or “decomposed substance” will be allowed by FDA.
Pet food consumers would like to have confidence in their choice of pet food, but with the FD&C Act stating one thing, and FDA allowing something completely different through Compliance Policies, that confidence is difficult to obtain with most pet foods. Same would hold true for consumers wanting to have faith and confidence in the pet food regulatory system. How can consumers have faith and confidence in FDA and State authorities if the FD&C Act is not enforced in full with pet foods? How can a pet ‘food’ be called a ‘food’ if it does not meet all the legal requirements of such?
Under question “5. What are the criteria for a mandatory recall?”
“A couple of conditions must exist before FDA can use its mandatory recall authority under section 423 of the FD&C Act.”
“First, FDA has to make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act.”
“Second, FDA has to make a determination that there is a reasonable probability that the use of or exposure to such food will cause SAHCODHA (serious adverse health consequences or death to humans or animals).”
For pet food consumers, we believe SAHCODHA (serious adverse health consequences or death to humans or animals) needs to be clearly defined. We ask FDA to define what the agency considers to be a serious adverse health consequence to pets. In order for consumers to know the FDA is acting on their pet’s best interest, a clear understanding of a serious adverse health consequence is necessary. We ask if FDA gives SAHCODHA consideration to an animal consuming – over a lifetime – a pet food made from “material from diseased animals or animals which have died otherwise than by slaughter”? ATPF urges FDA to give serious SAHCODHA consideration to these inferior quality pet food ingredients. We remind FDA, these are adulterated ‘food’ ingredients per the FD&C Act and should not be allowed into any pet ‘food’.
Consumers are pleased that FDA has mandatory recall authority with pet food. We ask FDA to enforce the FD&C Act in its entirety and ask the agency to remove all Compliance Policies that are conflicting with The Act. We ask FDA to provide consumers with detailed information to what quality of ingredients the agency will require of pet food. And we ask FDA to provide clear explanation to the serious adverse health consequences or death to animals that the agency will act upon.
on behalf of Pet Food Consumers
Association for Truth in Pet Food
Wishing you and your pet(s) the best,
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