Our Official Comments to FDA CVM Draft Guidance Documents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 The FDA Draft Guidance document stated: “A common or usual name is the name by which an article is known to the American public.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

Our comment submitted:

Association for Truth in Pet Food is a pet food consumer stakeholder organization that has been representing consumers for more than 15 years. We have had multiple meetings over the years with FDA, and have attended most AAFCO meetings during this 15+ year time frame. One continuous issue we have discussed with FDA CVM  is the lack of pet food consumer consideration when the agency makes decisions regarding pet food. We are discouraged, but not surprised, the agency has once again completely forgotten pet owners by your recent actions.

Please provide a detailed explanation to the differences and similarities between an animal feed ingredient, a GRAS ingredient, and an animal feed additive. The Draft Guidance document is catered to industry (instead of consumers) and takes for granted all reading the document understands the differences.

Of significant concern, the FDA CVM is attempting to control animal feed/pet food ingredients based solely on a “non-binding” Guidance document. It is unacceptable for the agency to take a non-binding regulatory position for pet food/animal feed ingredients.

Under “Background” the FDA CVM states: “This draft guidance describes FDA’s interim AFIC process and explains one way FDA intends to work with firms that are developing animal food ingredients after the MOU with AAFCO expires on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and GRAS Notification programs.“  FDA CVM’s use of the phrase “one way” indicating the agency has plans of ‘other ways’ to work with firms that are developing animal food ingredients. Please explain.

Under “Background” the FDA CVM states: “The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food.” However, in response to Citizen Petition FDA-2021-P-0436, FDA CVM stated: “…there is no Federal requirement that animal food ingredients be defined by regulation.”

This conflicting information provided by FDA CVM causes significant concern. We are concerned FDA CVM will at their discretion (as well due to non-binding Guidance) allow ingredients without definition or public notice. We are concerned that allies of FDA CVM will be provided with special privileges when the agency takes the stance of “…there is no Federal requirement that animal food ingredients be defined by regulation.” Please provide an explanation assuring the public all ingredient submissions will be approved through the same process.

The Guidance Document states: “AFIC also will give FDA an opportunity to discuss any potential safety concerns with the developer, ideally before the ingredient is marketed.” We ask FDA CVM to fully explain why “ideally” is included in the Guidance?

We ask FDA CVM to provide complete details to how definitions and names of ingredients will be determined? Who will write the definition and who will determine the ingredient name?

We ask FDA CVM to disclose to the public if analysis of new ingredients will be validated by FDA CVM? If yes, will that information be public? And if yes, how often will validation analysis occur?

We believe this Draft Guidance document cannot/should not be finalized.

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Pet owners can submit their own comments here: https://www.regulations.gov/document/FDA-2024-D-2978-0002

FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients Draft Guidance for Industry

Our comment submitted:

Association for Truth in Pet Food is a pet food consumer stakeholder organization that has been representing consumers for more than 15 years. We have had multiple meetings over the years with FDA, and have attended most AAFCO meetings during this 15+ year timeframe. One continuous issue we have discussed with FDA CVM  is the lack of pet food consumer consideration when the agency makes decisions regarding pet food. We are discouraged, but not surprised, the agency has once again completely neglected pet owners in your recent actions.

Having attended the most recent AAFCO meeting in San Antonio, TX, it was more than apparent that FDA CVM has been in direct communication with members and/or representatives of the Pet Food Institute prior to the release of these Draft Guidance documents. Please tell the public who at Pet Food Institute FDA CVM has communicated with prior to your August 8, 2024 announcement and how many instances did anyone from FDA CVM and PFI members/representatives communicate.

We suggest FDA CVM provide equal attention to FOIA requests (often filed by consumers and advocates) as the agency is now providing industry for ingredient approvals. I personally wait at least 2 years for any FOIA request and I have had multiple requests that took 3, 4, and 5 years. At this point, FDA CVM is ONLY catering to the wants of industry (ingredient approvals), again – ignoring consumers and consumer advocates.

We notice the two draft Guidance documents are both “non-binding”. Please provide the public an explanation how FDA CVM enforces non-binding guidance. Please fully explain how your enforcement actions differ between enforcing a rule or law from a non-binding Guidance document. Until we have a better understanding of enforcement of non-binding documents, our belief remains that FDA CVM enforces at will. ‘At will’ enforcement certainly benefits those that have close relationships with FDA CVM and of course hinders those that do not.

The Draft Guidance document “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients” discusses common or usual names of pet food/animal feed ingredients. As FDA CVM is aware, we filed a Citizen Petition regarding this very issue (FDA-2022-P-1643-0001), citing multiple (binding) federal regulations evidencing the existing common names of pet food ingredients mislead the public and violate federal law/rules. FDA CVM has not provided a response to this Citizen Petition that is more than two years old. 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 find it unacceptable that FDA CVM does not provide the public a full list of pet food ingredients with GRAS status. We request FDA CVM provide this complete information for the public. If the GRAS approvals are in your database as you state, it should be a simple process to provide that information to the public (which we deserve access to).

We do not believe this Draft Guidance document properly protects pet food consumers, it should not be finalized.

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Pet owners can submit their own comments here: https://www.regulations.gov/document/FDA-2024-D-2977-0002

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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