It’s a Jungle Out There: CVM Keeps Animal Drug Promotion and Manufacturing Quality in Its Sights

Key Takeaways

• FDA’s Center for Veterinary Medicine has emphasized its scrutiny of animal drug promotion and manufacturing quality. Recent enforcement actions indicate trends in compliance exposure for animal health companies, manufacturers, and distributors.
• Animal drug sponsors face similar promotional and manufacturing standards to human drugs. Misleading efficacy claims, minimized safety risks, cGMP deficiencies, and inadequate contract manufacturer oversight can trigger FDA enforcement.
• Animal health companies should strengthen compliance controls. Prioritize promotional claim substantiation, fair balance, manufacturing oversight, data integrity, and adverse event reporting to reduce regulatory and operational risk.

Randy Newman’s 2003 song written for the TV series Monk, “It’s a Jungle Out There,” came to mind when considering enforcement activity by FDA’s Center for Veterinary Medicine (“CVM”). At a recent conference on advertising and promotion of FDA-regulated products, a representative from CVM’s Office of Surveillance and Compliance emphasized that CVM shares many enforcement priorities with FDA’s human drug centers. While human drug enforcement often receives greater attention, animal drug companies face similar regulatory scrutiny. This Bulletin reviews recent CVM enforcement actions, examines how animal drug requirements align with those for human drugs, and offers practical compliance considerations.

FDA CVM Enforcement of Animal Drug Advertising and Promotional Claims

Most CVM enforcement letters have historically targeted unapproved new animal drugs rather than promotion of approved products. That balance has shifted, and since late 2023, CVM has issued a steady stream of promotional letters to major animal health sponsors.¹

• August 2026: CVM issued a Warning Letter to an outsourcing facility stating that claims comparing its compounded animal drug products favorably to approved or indexed drugs, and statements such as “Compliant with GFI #256” and “manufactured to FDA specifications,” were false or misleading.
• May 2026: CVM’s Untitled Letter to a leading animal health company regarding its long-acting injectable flea and tick product for dogs objected to “12 months of flea and tick protection” claims for a product approved to control the lone star tick for only eight months; the qualifier appeared in smaller text, reached by an asterisk or by scrolling. CVM also found a bar graph inconsistent with the Freedom of Information (“FOI”) Summary, a lack of fair balance, and an Important Safety Information (“ISI”) section that omitted hypersensitivity and anaphylaxis risks.
• January 2026: CVM’s Warning Letter to another animal health company found that “first pull” claims for its fluoroquinolone for cattle and swine respiratory disease contradicted a labeled caution to use the drug only after considering other options, that “all relevant pathogens” claims overstated the indication and could promote extra-label use, and that “2x the power in less than half the time” claims improperly relied on in vitro data.
• November 2023 – May 2025: CVM issued Warning Letters to a company regarding a canine dermatology drug’s truncated boxed warning in January 2025 and to another company for omitted or minimized risk information in February 2025. CVM also issued Untitled Letters to two other animal health companies regarding pain management, parasiticide, and antimicrobial products between November 2023 and May 2025.

FDA Enforcement of Animal Drug Manufacturing Quality and cGMP Compliance

• September 2026: CVM issued Warning Letters to a veterinary product distributor and a second firm after fungal contamination of a product labeled as sterile led to serious joint infections in nearly 100 horses, at least 20 of which were euthanized.²
  • In the related Warning Letter, FDA stated that it found insanitary manufacturing conditions and stressed that the distributor, which sold the product under its own label, was responsible for overseeing its contract manufacturer.
  • FDA also noted that the distributor marketed the product as a device and did not proactively report adverse events.
• October 2026: A veterinary compounding pharmacy recalled compounded medications shipped between February 18 and October 6, 2026, citing unreliable analytical testing data that could result in subpotent or superpotent products. It reported 98 complaints, seven of them serious.³
• April 2026: CVM issued a Warning Letter to a medicated feed mill after a drug mix-up caused at least 16 cattle deaths.
• Other recent letters, such as a July 2026 letter, have cited core cGMP failures such as releasing out-of-specification batches.
• In addition, in 2025, a federal court entered a consent decree enjoining an Arizona company from distributing unapproved animal drugs.⁴

How FDA Applies Human Drug Promotion and Manufacturing Standards to Animal Drugs

CVM’s recent letters closely resemble FDA correspondence for human drugs, reflecting consistent enforcement concerns across FDA offices.

• CVM cites the same provisions FDA’s Office of Prescription Drug Promotion (OPDP) for human drugs relies on sections 502(a), 502(n), and 201(n) of the Federal Food, Drug, and Cosmetic Act, and the prescription drug advertisements regulation at 21 C.F.R. 202.1(e)(5), including its fair balance requirement.
• Aligned with OPDP’s repeated note that a full indication or ISI in small font after intervening content does not cure a misleading message, CVM found that small-print qualifiers did not cure prominent product claims.⁵
• CVM measured claims against the FOI Summary and its prior communications with the product sponsor, and rejected comparative claims built on in vitro data, mirroring OPDP’s insistence on appropriate head-to-head data.
• Similar to off-label use enforcement for human drugs, the animal drug extra-label use regulations do not permit promotion of extra-label uses of approved animal drugs (21 C.F.R. § 530.4), and CVM weighs public health concerns unique to food-producing animals, such as antimicrobial resistance.
• The cGMP regulations for finished pharmaceuticals apply to drug products “for administration to humans or animals,” with additional rules for medicated feeds and Type A medicated articles (21 C.F.R. Parts 225 and 226).⁶
• Where the rules diverge: The section 503B outsourcing facility exemptions for compounded products apply only to human drugs, not animal drugs.

What Animal Health Companies Should Know About CVM Enforcement Risks

• This recent reminder confirms what the enforcement record suggests: companies should not assume that veterinary or pet owner audiences receive less scrutiny than human drug audiences.
• Many cited deficiencies appeared in materials that may receive lighter review, such as technical manuals and sales presentations, but every channel should go through a robust promotional review process.
• CVM is reading promotion alongside the FOI Summary and the sponsor’s regulatory history, so claims that stretch beyond the approved indication are vulnerable, particularly where CVM has already stated its position.
• Recent enforcement examples remind sponsors and distributors that they remain responsible for products made by contract manufacturers, and that adverse event reporting and data integrity can trigger enforcement.

Five Compliance Steps Animal Drug Companies Should Take Now

1. Map each benefit claim and graphic to the approved labeling and FOI Summary and present any limitation on the indication with comparable prominence.
2. Give risk information the same visual weight as benefit information and tailor the ISI to the specific product promoted.
3. Treat labeled cautions, especially for medically important antimicrobials, as limits on promotional positioning.
4. Consider CVM’s voluntary pre-dissemination review for launch materials.⁷
5. Revisit quality agreements and audits for contract manufacturers, particularly for sterile products.

Warning Letters and Untitled Letters often precede more formal enforcement if concerns are not addressed. Bringing it back to Randy Newman and Monk, it is a jungle out there, and CVM wants to remind companies to keep their own eyes on compliance. For guidance on these issues, please contact a member of AGG’s Food & Drug team.

[1] CVM’s Untitled Letters page is available here; FDA’s Warning Letters page is available here.

[2] FDA’s September 29, 2026, CVM Update is available here.

[3] The October 21, 2026, recall announcement is accessible through FDA’s animal and veterinary Recalls & Withdrawals page, available here.

[4] The Department of Justice’s April 29, 2025, press release is available here.

[5] Please see our previous Bulletins: (In)Box Full of Letters: OPDP Published Untitled Letter Regarding Emails to Healthcare Professionals and Beyond The Fine Print: OPDP’s 2026 DTC Letters Redefine Net Impression.

[6] 21 C.F.R. § 211.1(a), available here.

[7] FDA’s overview of CVM’s promotional oversight, including pre-dissemination review, is available here.