Letter to Aquaculture Professionals
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 drugs for food fish. The agency has reviewed these drugs to make sure they’re safe and effective when used according to the directions on the labeling. The agency has also reviewed information for each drug to ensure that food made from treated fish are safe for people to eat.
Not all the drugs listed in the tables are currently marketed. However, if a drug is currently marketed for food fish but isn't listed in the tables, 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 Drugs for Food Fish - Immersion Products
| Trade Name (active ingredient) | Application Type & Number |
|---|---|
| HALAMID® AQUA (chloramine-T powder) |
NADA1 141-423 |
| FORMACIDE-B (formalin) |
ANADA2 200-414 |
| FORMALIN-F™ (formalin) |
NADA 137-687 |
| PARASITE-S (formalin) |
NADA 140-989 |
| 35% PEROX-AID® (hydrogen peroxide) |
NADA 141-255 |
| OXY Marine™ (oxytetracycline hydrochloride) |
NADA 130-435 |
| Tetroxy® 343 (oxytetracycline hydrochloride) |
ANADA 200-247 |
| Pennox 343® (oxytetracycline hydrochloride) |
ANADA 200-026 |
| Terramycin-343® (oxytetracycline hydrochloride) |
NADA 008-622 |
| TETROXY® Aquatic (oxytetracycline hydrochloride) |
ANADA 200-460 |
| SYNCAINE (tricaine methanesulfonate) |
ANADA 200-226 |
FDA-Approved Drugs for Food Fish - Injectable Products
| Trade Name (active ingredient) | Application Type & Number |
|---|---|
| CHORULON® (chorionic gonadotropin) |
NADA 140-927 |
FDA-Approved Drugs for Food Fish - Type A Medicated Articles Used to Make Medicated Feed
| Trade Name (active ingredient) | Application Type & Number |
|---|---|
| Aquaflor® (florfenicol) |
NADA 141-246 |
| Terramycin® 100 for Fish and Terramycin® 200 for Fish (oxytetracycline dihydrate) |
NADA 038-439 |
| Romet® 30 (sulfadimethoxine & ormetoprim) |
NADA 125-933 |
| SULFAMERAZINE FISH GRADE (sulfamerazine) |
NADA 033-950 |
1NADA – New Animal Drug Application.
2ANADA – Abbreviated New Animal Drug Application for a generic animal drug.
Please see Animal Drugs @ FDA for more information about each drug, including the specific fish species or groups of fish it’s approved for, the specific uses, and the withdrawal period.
FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for all animals. For more information, please visit Approved Aquaculture Drugs or contact CVM at 240-402-7002 or AskCVM@fda.hhs.gov.
Sincerely,
FDA’s Center for Veterinary Medicine