No, no FDA – you cannot have it both ways

FDA recently issued a Guidance document that misleads the public (at least the pet owning public). We submitted our comments calling the agency out on their double standard of regulation.

In February of 2019, the FDA released “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” This document is a “Guidance” document which means it is not law, it is not legally binding. Guidance documents are more of an ‘announcement’ to industry and the public as to how FDA will enforce laws (or in many cases not enforce law). In this case the Guidance document was about how FDA plans to manage ‘Public Warnings’ and recall notices.

You can read the full FDA document Here.

There are several issues that are unjust to pet owners within the new recall Guidance document. Through our consumer association – AssociationforTruthinPetFood.com – we submitted to FDA our comments calling out the agency’s double standards. To read our full response, Click Here. And ATPF’s comment should be posted soon on the Guidance document page at the Regulations.gov website.

One significant issue that we addressed with FDA is this Guidance document tries to lump the recall notice requirements of all FDA regulated products into one – when the agency regulates those products very differently.

As example, through other Guidance documents FDA allows many materials into feed grade pet foods (feed) that the agency would never allow into ‘food’. Such as: CPG Sec. 690.300 – “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.”

The FDA would NEVER allow any ‘food’ (any product regulated as food) to contain “material from diseased animals or animals which have died otherwise than by slaughter“, yet the agency openly allows this material in pet ‘food’.

It is more than misleading to the general public that the FDA pretends in one Guidance document all ‘foods’ are regulated equally when in another Guidance document we have confirmation all ‘foods’ are not regulated equally. Compliance policies written by the FDA allow the pet food (and livestock feed) industry to violate federal law. FDA has two very different standards of regulation of food products (human food and pet feed), thus our comment to the document was that FDA must acknowledge that fact publicly and prepare a separate Guidance for products regulated as feed.

In the new Guidance document, the FDA completely skips over a section of law that would be a benefit to all pet owners. Federal law includes recall notices to become public when a risk product reaches the consumer level, retail level AND/OR distributor/wholesale level. The FDA guidance document neglects to mention this significant point. We asked FDA to require distributor level recalls (products that never made it to stores or to consumers) to become public notices.

A confusing part when reading the Guidance document is that FDA considers a “public warning” to be the same thing as a recall notice. However, they are two different things when it comes to a manufacturer issued ‘public warning’ recall notice and an FDA issued ‘public warning’. The Guidance document was concerning when FDA never provided any legal clarification to what regulations they (FDA) are held to when the agency issues a public warning.

As example, the FDA has taken the authority to issue public warnings about several raw pet food companies – two of which were issued during the government shutdown. As this Guidance document is supposed to provide transparency to the public on how the FDA will handle public warnings of all types – manufacturer issued or FDA issued – we believe it is in the best interest of pet owners for FDA to provide the laws that the agency is held to in these situations. Our comment to FDA (in part) was “The disclosure to legal requirements FDA must adhere to regarding agency issued public warnings will benefit pet owners, and perhaps (if FDA is abiding by those federal regulations) begin to build pet owner trust in the agency.”

One of the most misleading issues found in this new Guidance document is an example given by FDA on where the agency will require a recall. Bold added for emphasis of FDA double standard: “Recalls of food products initiated because of microbiological pathogen findings (e.g., Listeria monocytogenes, Salmonella, etc.) in environmental testing where direct food manufacturing contact surfaces are found to be contaminated.”

This is absolutely not the standard pet food (feed) manufacturers are held to. And our response provided clear evidence of the FDA double standard of regulation:

“FDA has historically shown complete disregard for pathogenic bacteria on “direct food manufacturing contact surfaces” within pet food (feed) manufacturing including taking no regulatory action (no public warning issued) of significant pest infestation in feed grade manufacturing facilities.”

“Evidence to this: “Inspectional Observations” stated in FDA EIR from Mars Petcare, Columbus, OH in 2017 found the pet feed manufacturer failed to 1) “inspect, segregate, or otherwise handle raw materials and ingredients used in manufacturing under conditions that will protect the animal food against contamination and minimize deterioration.” And 2) Mars Petcare failed “to take effective measures to exclude pests from your plant and protect against contamination of animal food by pests.” No public warning was issued on these pet food (feed) products by the manufacturer or by FDA. The double standard of regulation of pet feed products and ‘food’ products (even though the FD&C Act includes animal food under the legal definition of food) cause confusion with pet owning consumers buying pet products. Because of the distinctly different ways FDA regulates ‘food’ and ‘feed’, as exampled by this Mars Petcare EIR, we ask FDA to prepare a separate Guidance document specific to feed products.”

The FDA cannot have it both ways. They cannot tell the public they are regulating pet products as food when numerous other FDA Compliance Policies evidence that pet food products are nothing similar to food. They made this double standard bed – they must sleep in it.

In October of 2016, AssociationforTruthinPetFood.com filed a Citizen Petition with FDA asking for the agency to end the illegal Compliance Policies allowing hideous waste into pet food – and we cited a Supreme Court ruling as foundation for our request. We asked the FDA to clearly label pet ‘food’ products for transparency to pet owners. If the product meets ‘food’ regulation – it is labeled as dog food and cat food. But if the product does not meet all legal requirements of food (those regulated as feed), we asked the agency to provide transparency to pet owners, requiring those products to be labeled as dog feed and cat feed.

To read the original Citizen Petition submitted October 2016, Click Here. To read the Addendum, Click Here.

Almost 2/12 years later, the FDA has never responded to our petition.

Any pet owner is welcome to provide comment to the new FDA recall Compliance policy. To read the policy, Click Here. To post a comment, Click Here and the page that opens provides a link to comment on the right side of the page (blue box – Comment Now).

Any pet owner can send FDA comments on any issue or ask questions. Email the agency: AskCVM@fda.hhs.gov

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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