Our Official Comments to FDA CVM Draft Guidance Documents

The FDA Center for Veterinary Medicine (CVM) has recently published multiple Guidance Documents and a Notice in the Federal Register and on the government website Regulations.gov. All documents are specific to FDA CVM taking sole control over pet food/animal feed ingredient definitions. The FDA CVM has made them available for comment for a brief period of time.

Brief overview of our comments.

One issue of concern with FDA CVM is “common names” of ingredients (discussed in third comment below). The FDA Draft Guidance document stated: “A common or usual name is the name by which an article is known to the American public. Common or usual names must not be misleading (see section 403(a)(1) of the FD&C Act).”

Specific to ‘misleading’ we asked the FDA CVM to respond to this:

We ask FDA CVM to provide the public an explanation to how (as example) the ingredient ‘Chicken’ in pet food – allowed to be sourced from condemned poultry – is not misleading pet owners when Chicken “known to the American public” is USDA inspected and passed.

We asked the agency to validate through laboratory analysis all ingredients submitted to the agency for approval.

We asked the agency to explain why pet food/animal feed ingredient approvals will be processed through Guidance Documents which are “non-binding” instead of through regulations.

And slightly outside of what the agency is looking for, we asked FDA CVM to provide pet food consumers with equal time as they are currently providing industry. Within these Guidance Documents the FDA asked questions of industry – such as ‘how can we make the ingredient approval process better?’, ‘what is currently required that doesn’t need to be?’ The agency is even hosting “listening sessions” for industry regarding the ingredient approval process. We made the suggestion that FDA CVM do the same for pet owners. We suggested the agency ask pet owners what they need from FDA CVM, what information is needed on pet food labels to help evaluate the pet food?, and we asked the agency to host in-person and virtual listening session solely for pet owners.

Our official comments submitted are below.

FDA document: Pre-Market Animal Food Ingredient Review Programs; Request for Comments

Our comment submitted:

FDA CVM defines a food additive, and provides explanation of GRAS – however the Notification does not provide explanation if a food additive and/or a GRAS ingredient is also considered an “ingredient” of animal feed. Please provide an explanation to pet food consumers to the differences and similarities between a food/feed additive, GRAS, and a food/feed ingredient.

FDA admits their public GRAS “lists are not all-inclusive”. This is unacceptable for pet food consumers. Consumers should have public access to all GRAS ingredients that might be included in their pet’s food or treat.

We provide our response to one FDA CVM question:

5. What review process for proposed animal food ingredients would best enable FDA to review their safety?
It should be required of FDA CVM to validate all laboratory analysis (through independent testing) provided with each Food Additive Petition and GRAS Notification submission. All results – both submitter lab analysis and FDA CVM lab analysis – should be provided for public view.

Though not requested information, as a representative of pet food consumers we have to ask FDA CVM why the agency has never solicited pet owner opinion regarding FDA CVM’s regulation of pet foods? FDA CVM has gone to extensive lengths to improve the process of animal feed/pet food ingredient approvals – improve conditions for industry, yet we have never seen any similar effort to improve conditions for pet food consumers. Information from FDA CVM for pet food consumers is so drastically lacking, we (Association for Truth in Pet Food/TruthaboutPetFood.com) were forced to file a Citizen Petition (FDA-2024-P-1916-0001) asking the agency to update pet food consumers to a recent surge in sick and dead pets related to pet food. What FDA CVM finally provided consumers was little more than a smoke and mirror report. The agency attempted to mislead the public that an investigation was performed into these many pet illness and death reports, when it was actually a regular inspection of one single pet food plant. 

FDA CVM takes the position of ‘we tell pet owners only what we want them to know’. We ask the FDA CVM instead, to ask the largest stakeholder of pet food – consumers – what they want from FDA CVM/what they need from FDA/CVM to better protect their pet. We ask FDA/CVM to host multiple listening sessions specifically for pet food consumers, both in-person and virtual listening sessions. We ask the agency to give pet food consumers the very same courtesy and involvement you give industry. We also ask the agency to submit in the Federal Register, open for public comment, a request for responses to the following example questions (similar to the questions asked of industry in this Notification):

1. What do you perceive as barriers to selecting a pet food?

2. Are there changes, such as regulatory changes, changes to guidance, or changes to FDA policy or processes – that would make your selection of a pet food easier?

3. Is there information that is currently required on a pet food label, required of a pet food manufacturer, that you do not think is necessary for evaluating the pet food?

4. Is there information that is not currently required on a pet food label or required of a pet food manufacturer, but should be to better enable your evaluation of a pet food?

5. What review process for proposed animal food ingredients would best enable you to trust their safety?

6. If you have ever submitted a pet food adverse event report to FDA CVM, please provide us feedback on our reporting process. Do you feel satisfied with the outcome of your report submitted to us?

We do not believe the FDA CVM has the best interest of pets/pet food consumers with this Pre-Market Animal Food Ingredient Review Program. 

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Pet owners can submit their own comments here: https://www.regulations.gov/document/FDA-2024-N-2979-0001

Animal Food Ingredient Consultation (AFIC) Guidance for Industry Draft Guidance

A big thank you to pet owner friends at EarthDay.org for taking action on this issue as well, urging pet owners to post comments. Click Here to read their press release.

Will the FDA CVM listen to us, consider our comments? We don’t know. But, we have to try. Do not hesitate to submit your comments to FDA.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food

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