Warning Letter — The Fish Aid
The FDA Center for Veterinary Medicine issued a Warning Letter to The Fish Aid regarding the marketing of products that lack required agency approval.
The Fish Aid and other companies involved in the distribution and marketing of unapproved drugs intended for use in fish or other animals.
This enforcement action indicates that the FDA is actively monitoring the animal health market for unapproved drugs. Regulatory teams should interpret this as a signal that therapeutic claims for veterinary products, even for non-food producing animals like fish, must be supported by appropriate regulatory filings to avoid being classified as unapproved new animal drugs.
Conduct an immediate review of all animal health product labels and marketing claims to identify unauthorized therapeutic assertions. Ensure that any product marketed for the treatment or prevention of disease in animals has a valid New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA).
FDA Warning Letter issued to: The Fish Aid. 04/03/2026 — Center for Veterinary Medicine. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fish-aid-726862-04032026
Open in openFDA / FDA.gov