---
title: "Recall or not? Reading the regulatory spectrum from the DCM investigation's close"
author: codebuddy
type: article
series: enforcement-recalls
desc: "The DCM investigation closed without a recall — a mechanism contrast with high-frequency Salmonella recalls and the turn to private litigation."
source_topics: FDA_DCM_investigation_timeline_2014_2024, FDA_DCM_investigation_closure_2022_dec, FDA_DCM_post_closure_science_2023_2025, keto_natural_v_hills_lanham_act_lawsuit_2024_2025, FDA_pet_food_recall_classification, FDA_pet_food_recall_2026, FDA_CVM_petfood_oversight
date: 2026-07-30
---

# Recall or not? Reading the regulatory spectrum from the DCM investigation's close

*Part two of the regulatory-spectrum companion to the DCM evidence-chain article.*

## A spectrum, not a switch

"Recall" is the word most people reach for when a pet-food scare hits the news. But the regulatory record shows a recall is only one point on a wider spectrum of government responses — the same agency can mount a 4.5-year investigation and close it without pulling a single bag from the shelf, yet trigger a Class I withdrawal on a contamination finding. The diet-associated dilated cardiomyopathy (DCM) story and the standing FDA recall framework sit at opposite ends of how enforcement power is actually exercised.

## The DCM close: a 4.5-year investigation, no recall

On **December 23, 2022**, FDA updated its consumer-facing DCM investigation page with what became the most consequential sentence of the entire episode: *"FDA does not intend to release further public updates until there is meaningful new scientific information to share."* That date is the official investigation closure for the FDA public record.

The reason no recall followed is spelled out on the same page. The agency stated that, *"by themselves, they do not supply sufficient data to establish a causal relationship"* between the reported diets and DCM — a methodological position, not a denial that diet might matter. As the companion science topic puts it, the closure should be read as *"no causal-link statement has been made"* rather than *"no causal link exists."*

The practical result is blunt: *"The DCM signal is not a recall event — no product was withdrawn from market based on the FDA investigation."* A vast reporting effort — by **November 1, 2022** the page carried a final public case count, and the underlying timeline shows **>1,100 reported to FDA** through 2020-09, with **340 dogs + 9 cats** medical records reviewed and **202 dogs + 6 cats** confirmed DCM — nonetheless ended with no enforcement withdrawal, because the adverse-event data did not establish causation.

The signal was real enough to act on clinically: in the investigation's diet analysis, **91%** of reported products were grain-free and **93%** were pea- and/or lentil-rich, and **107 fully or partial recovery** cases improved after a diet change. But a recoverable cardiac pattern is not the kind of verifiable hazard the recall statute is built to address.

## The recall machinery: three classes

Where the DCM file stayed open-and-unresolved, routine contamination enforcement runs through a fixed, classification-driven ladder:

- **Class I (most serious): reasonable probability that use of the product will cause serious adverse health consequences or death.** Textbook examples include *Salmonella in high-moisture food*, *aflatoxin >100 ppb*, *melamine >50 ppm*, and *vitamin D >10,000 IU/kg in dogs*.
- **Class II: temporary or medically reversible health consequences, or probability of serious consequences is remote.** Examples include *low-level aflatoxin 20-100 ppb*, *vitamin D 5,000-10,000 IU/kg*, *Listeria monocytogenes in frozen raw food*, and low-level heavy metal contamination.
- **Class III: violation of FDA labeling or manufacturing regulations where health consequences are unlikely.** Examples include *net weight discrepancy*, *mis-ordered ingredient list*, and *color additive naming error*.

Crucially, *"FDA may mandate Class I/II recalls or accept manufacturer-initiated recalls; Class III recalls are typically voluntary."* The mechanism is triggered by a concrete, measurable hazard, not by a statistical association in voluntarily submitted adverse-event reports.

## The contamination lane: Salmonella and friends

This is the lane DCM never entered. When a hazard is discrete and verifiable — *Salmonella in high-moisture food* under Class I, or *Listeria monocytogenes in frozen raw food* under Class II — the framework supplies both the trigger and the severity grade. The contrast with DCM is structural: contamination findings give the agency the kind of primary, confirmable fact the classification system is built around, whereas the DCM record, in FDA's own phrasing, *"do not supply sufficient data to establish a causal relationship."*

A separate topic describing 2026 H1 recall activity lists a Hill's Science Diet product with "potential Salmonella contamination" (Class II) among its examples. **That topic is flagged here as pending / unverified:** it carries no retrieved date and no source_file on disk (generated from the topic text alone), so its specific figures — "12 Class I/II/III recalls" or "4.2 million lbs" — are **not** treated as confirmed fact. It is mentioned only to show the contamination-recall shape; the verified recall framework above is the load-bearing source for any concrete claim.

## When the agency stays silent: the Lanham Act detour

Because FDA closed without a recall and without a causal finding, the dispute about what grain-free diets "did" migrated into the courts. In **February 2024**, KetoNatural Pet Foods filed a **$2.6 billion Lanham Act false advertising lawsuit** against Hill's Pet Nutrition (a Colgate-Palmolive subsidiary), the Morris Animal Foundation, the Mark Morris Institute, and five veterinary researchers — Drs. Lisa Freeman, Joshua Stern, Darcy Adin, Ryan Fries, and John Rush — alleging they had "weaponized" the FDA's DCM reporting system to suppress the grain-free segment.

The two claims were false advertising under the Lanham Act (**15 U.S.C. § 1125(a)(1)(B)**) and a civil conspiracy under Kansas state law. In **November 2025**, the **United States Court of Appeals for the Tenth Circuit affirmed the dismissal** of the complaint. The panel held that the challenged Hill's statements characterized *"the FDA investigation record"* rather than making actionable establishment claims, and that the veterinarians' statements were *"first-party statements by the scientists themselves."* The result is a **procedural win for Hill's** — it adjudicated the lawsuit's pleading, not the underlying science.

That matters for the spectrum argument: when the agency declines to convert a signal into an enforcement action, private litigation becomes the alternative arena — a procedural outcome about commercial speech, not a substitute for the recall authority FDA chose not to exercise on DCM.

## Where the authority actually lives: FDA CVM

The body that would have issued any DCM-related recall is the **FDA Center for Veterinary Medicine (CVM, established 1984)**, the **primary FDA center responsible for pet food safety oversight**. Its jurisdiction covers *pet food (dogs, cats, other companion animals), animal drugs, medicated feeds, veterinary devices* — with a clear boundary: *CVM does NOT have jurisdiction over feed for food-producing animals destined for human consumption*. 

CVM's Office of Surveillance and Compliance handles four things directly relevant here: pet food adverse event reporting (with *over 1,000 formal complaints logged in 2025*), inspection of pet food manufacturing facilities, *recall authority for non-compliant pet foods*, and *AAFCO coordination on nutrient profiles*. The center operates with *130 staff and approximately USD 25M annual budget for pet food oversight*. The adverse-event portal is exactly the channel that fed the DCM case count — and, as the closure statement noted, FDA *"is unable to investigate every report to verify or confirm the reported information."*

## Reading the spectrum

Lined up, the contrast is clean:

1. **DCM (2014–2022):** a large, multi-year signal — **>1,100 reported to FDA**, **202 dogs + 6 cats** confirmed — closed on **December 23, 2022** with *"no product was withdrawn from market"* because the data *"do not supply sufficient data to establish a causal relationship."*
2. **Contamination recalls:** discrete hazards like *Salmonella in high-moisture food* or *Listeria monocytogenes in frozen raw food* trigger a graded Class I/II/III response.
3. **Private litigation:** when the agency stays silent, parties turn to the Lanham Act — a **$2.6 billion** claim the **Tenth Circuit affirmed dismissal** of in **November 2025**, resolving procedure rather than science.

The throughline is that FDA's pet-food power is real but conditional. CVM holds *recall authority for non-compliant pet foods*, yet on DCM it exercised that authority only to the extent of publishing and retiring a case count. The recall ladder exists for hazards it can measure; the DCM story shows what happens when the hazard is a correlation the agency will not, on the record, call causal.

## Sources

- **FDA_DCM_investigation_closure_2022_dec** — closure date (December 23, 2022), "no causal relationship" statement, "no product was withdrawn from market." (Verified, retrieved 2026-07-20.)
- **FDA_DCM_investigation_timeline_2014_2024** — case counts (>1,100 reported; 340 dogs + 9 cats; 202 dogs + 6 cats), diet profile (91% grain-free, 93% pea/lentil), recovery counts. (Extracted via Tavily, 2026-07-20.)
- **FDA_DCM_post_closure_science_2023_2025** — "no causal-link statement has been made" vs "no causal link exists"; "strong link … particularly regarding legumes"; Veterinary Sciences 2025;12(11):1106. (10/10 claims verified, 2026-07-21.)
- **keto_natural_v_hills_lanham_act_lawsuit_2024_2025** — $2.6B Lanham Act suit (Feb 2024), 15 U.S.C. § 1125(a)(1)(B), Tenth Circuit affirmance (Nov 2025), "procedural win for Hill's." (9/9 claims verified, 2026-07-21.)
- **FDA_pet_food_recall_classification** — Class I/II/III definitions and examples (Salmonella, Listeria, aflatoxin, vitamin D, labeling defects). (Official web page; C1 source.)
- **FDA_CVM_petfood_oversight** — CVM established 1984, jurisdiction, 1,000+ complaints in 2025, 130 staff / ~USD 25M budget, recall authority. (Official source; needs_review flag.)
- **FDA_pet_food_recall_2026** — **PENDING / UNVERIFIED.** No retrieved date, no source_file (generated from topic text only). Specific 2026 figures (e.g. "12 recalls", "4.2 million lbs") are NOT treated as confirmed in this article; referenced only to illustrate the contamination-recall shape.