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Important information from FDA on Aspirin use in food animals

Aspirin (acetylsalicylic acid; ASA) is widely available in over the counter formulations including boluses or soluble solutions for use in food animals. However, these products are not FDA approved for any veterinary species. Withdrawal recommendations may be listed on the product labels, but these have not been evaluated by the FDA. Some products specifically state a zero-day meat and milk withdrawal, but this information is not supported by FDA reviewed data. The FDA recently released a "Dear Veterinarian" letter on this topic, highlighting that extra-label use of non-FDA-approved medications (such as these unapproved OTC aspirin products) in food-producing species is prohibited per AMDUCA legislation. Also, since there are no FDA-approved ASA products for use in any veterinary species, the tolerance is zero for any residues (i.e. any detectable residue would be considered violative). For more information, please see the attached info sheet on this topic.

FARAD Funding Update

FARAD continues to be funded on a year-to-year basis and gratefully acknowledges stakeholders' support, notably the American Veterinarian Medical Association (AVMA). FARAD funding is provided through USDA-NIFA authorized through the FARM Bill.

From 2018-2024, AVMA requested $2,500,000 for FARAD to carry out its vital services, which help keep the U.S. food supply safe, secure and affordable. FARAD was fully funded at the requested level from 2018-2023, but has suffered a devastating 20% reduction in budget appropriated for the 2024-2025 funding cycle. In 2023, FARADs highly trained scientists directly assisted with 5,833 inquiries impacting 5.8 million animals representing dairy, beef, swine, poultry, small ruminant and honeybee production systems. Compared to 2018, FARAD has had a 62% increase in inquiries, including a 33% increase from 2022 to 2023 alone. Although FARAD has operated at its authorized amount since 2018, it has been unable to invest and grow the program. With the cut in funding for 2024, the FARAD program has lost key personnel and will have fewer scientists available to respond to inquiries. AVMA is urging increased authorization to $5 million for FARAD in the 2023 FARM Bill, in order to help FARAD attract and retain scientists, keep pace with inflation, invest in technology and conduct critical safety validation studies. View the AVMA position statement for FARAD funding for 2025 and for the increase in funding for the upcoming Farm Bill. Stakeholders are urged to contact their US Congressional Representatives to voice support for the FARAD program.

You can find more information on our funding page.

Popular Topics

Holsteins taken by Mark Hoffenberg

Search VetGRAM

Search our online database of uses, restrictions and required withdrawal times (WDT) for FDA drugs approved in food animal species.

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Request ELDU Advice

If you are a licensed veterinarians, please use our FREE online submission form for questions regarding accidental chemical contamination or drugs used in an extralabel manner in food animals.

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Digest WDI Search

FARAD-recommended Withdrawal Interval Recommendations for selected extra-label uses of a limited number of drugs.

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Prohibited and Restricted Drugs

The FDA can limit the prohibition on extra-label use to specific species, indications, dosage forms, routes of administration, or a combination of these, as well as prohibit them from use in any food-producing animal.

Group of goats by Jorge Salvador

Extra-label Drug Use

Learn about the law, requirements, and restrictions of extra-label drug use.
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Veterinary Feed Directive

A VFD Order is a written statement from a licensed veterinarian that authorizes a client to use a VFD drug.
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Species Specific Website

Drug handling and species specific operation information for veterinarians, pharmacists and producers.
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Search Bibliographic Citations

This database contains documents that have time versus concentration data for live animals with a focus on food animal species.
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Animal Use Classes

Definitions of use classes for Major Food Animal, Companion Animal and Minor Species, as defined by the FDA.
Sheep Photo, courtesy Don Preisler

AMDUCA

FARAD exists because of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).

Guidance for Industry (GFI) #263

FARAD FAQs regarding GFI 263: OTC to RX

How US FARAD Can Help You Smooth Out the Transition from Over-the-Counter (OTC) Medically Important Antimicrobials (MIAs) for animals to Prescription Status (Rx)

Transition of Medically Important Animal Antimicrobials to Prescription Status

The U.S. Food and Drug Administration is announcing the successful implementation of Guidance for Industry (GFI) #263 to transition Over-the-Counter (OTC) Medically Important Antimicrobials (MIAs) for animals to Prescription Status (Rx)

GFI #263: Medically important antimicrobials

Listen to the AABP podcast "Guidance for Industry (GFI) #263 is part of the FDA’s five-year plan which will move the remaining medically important antimicrobials under veterinary oversight.

Approved animal drugs affected by GFI #263

All affected animal drug sponsors opted to either voluntarily change the marketing status of certain MIAs for animals from (OTC) to (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications.