Dear Aquaculture Professional:

The U.S. Food and Drug Administration (FDA) wants to remind you that not all drugs currently marketed for food fish (fish that will enter the human food supply) are approved. And even if a marketed product has the same active ingredient as an FDA-approved drug, that doesn’t mean it’s also FDA-approved.

The tables below list all FDA-approved fish drugs. The agency has reviewed these drugs to make sure they’re safe and effective in fish when used according to the label. All listed drugs are also approved for food fish. If a drug currently marketed for food fish isn't listed, then it's an unapproved animal drug, and therefore, hasn’t been shown to be safe and effective in food fish. For example, only the three listed formalin products are approved by FDA to control diseases in food fish. Any other formalin-containing products that are marketed to control diseases in food fish are not FDA-approved.

Benefits of FDA Approval

FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA that:

• The drug is safe and effective for a specific use in a specific animal species. For food fish intended for human consumption, the drug company must also prove that food made from fish treated with the drug is safe for people to eat;
• The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The company must show that the drug can be consistently produced from batch to batch; and
• The drug’s labeling is truthful, complete, and not misleading. The company must make sure that the labeling contains all necessary information to use the drug safely and effectively and includes the risks associated with the drug.

FDA’s role doesn’t stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:

• The drug's safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
• The manufacturing process to ensure quality and consistency are maintained from batch to batch;
• The drug's labeling to make sure the information remains truthful, complete, and not misleading; and
• The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.

FDA-Approved Fish Drugs - Immersion Products

FDA-Approved Fish Drugs - Injectable Products

FDA-Approved Fish Drugs - Type A Medicated Articles Used to Make Medicated Feed

¹The drug’s established name is the active ingredient.
²NADA – New Animal Drug Application.
³ANADA – Abbreviated New Animal Drug Application for a generic animal drug.

Besides the approved drugs listed in the above tables, three drugs for ornamental (non-food) fish are on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.

FDA-approved animal drugs are scientifically shown to be safe and effective when used according to the directions on the label. If the approved drugs are for food fish, food made from treated fish is safe for people to eat. FDA-approved animal drugs also meet the agency’s strict standards for quality, purity, and potency.

FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals. For more information, please visit the Approved Aquaculture Drugs webpage or contact CVM's Education & Outreach Staff at 240-402-7002 or [email protected].

Sincerely,

FDA’s Center for Veterinary Medicine