By Guy Jodarski, DVM, Holistic Veterinarian
The Food and Drug Administration (FDA) recently warned veterinarians and farmers to stop using aspirin to treat fever and pain in lactating dairy cattle. In a "Dear Veterinarian" letter* published October 11, 2024, FDA (in part) stated, "The U.S. Food and Drug Administration understands that veterinarians and dairy farmers may be treating lactating dairy cattle for pyrexia and pain with aspirin and wants to clarify that there are no FDA-approved aspirin products for use in cattle. The extralabel use of unapproved drugs in food-producing species is prohibited."
"There are FDA-approved products for controlling pyrexia and pain in lactating dairy cattle that are safe, effective, and have established milk and meat withdrawal periods"...
... "FDA understands that veterinarians and dairy farmers may instead be using unapproved aspirin products that are not legally marketed. The extralabel use of unapproved drug products in food-producing species is prohibited."
"Veterinarians and dairy farmers should stop use of unapproved aspirin in lactating dairy cattle and use FDA-approved products to control pyrexia and pain. In the event that animals have already been treated with aspirin, veterinarians should use their scientific expertise and available resources to set protective and extended milk and meat withdrawal periods for treated animals." (emphasis added, pyrexia = fever)
Aspirin has never gone through the FDA approval process required for drugs used in food animals.* In the past, FDA considered aspirin use to be of "low regulatory concern" and did not enforce the prohibition against using this unapproved drug in food animals. The previously "allowed" use of aspirin as prescribed by veterinarians for controlling pain and/or fever in cattle has now been reversed by FDA as described in the above quoted letter.
Several common materials used to treat dairy cattle such as calcium solutions, lidocaine, propylene glycol, sedative/tranquilizers, etc. have never been approved for use in food animals. Most of these are considered unapproved drugs by FDA and regulatory officials. The process to gain approval for food animal drugs is long and expensive. Companies making these materials often do not seek FDA approval because the cost is too high. Natural remedies used to treat organic livestock fall into this category. Many of these treatments (considered drugs by FDA) can still be used on an individual case basis if there is no approved option available and the material is considered to be of low regulatory concern. Aspirin use in cattle no longer has this status as an unapproved drug.
What changed? The US outbreak of Influenza A, H5N1 (HPAI, "bird flu") in dairy cattle continues to grow - over 330 dairy herds in 14 US states have been diagnosed. Recently California has experienced a rapid increase in dairies affected (>120 as of this writing). Many dairy cows infected with H5N1 in CA were being treated with aspirin to control fevers. Concerns about aspirin residues in the milk supply has been cited as the reason for the new FDA position.
*Source: https://hoards.com/article-35775-fda-officially-takes-aspirin-off-the-table.html
The use of unapproved drugs in food animals is allowed with restrictions that include veterinary oversight. The conditions to be met are detailed in the Animal Medicinal Drug Use Clarification Act, known as AMDUCA. To allow extralabel drug use, a valid veterinarian-client-patient relationship (VCPR) must be established, an appropriate withdrawal time must be assigned, Illegal residues must not result, and only approved human or animal drugs may be used. AMDUCA says a veterinarian should not prescribe a drug in an extralabel manner if there is an approved drug that is labeled for the indication unless that labeled therapy is ineffective as determined by the veterinarian.*
https://www.avma.org/news/fda-warns-against-use-unapproved-aspirin-lactating-dairy-cattle
If you have a cow currently being treated with aspirin, please stop giving aspirin. We recommend a withdrawal time of at least five days for both milk and meat after the last dose of aspirin.
The main alternative for treating cows with fever or pain is flunixin meglumine (Banamine® or generic flunixin), injectable (IV-use only) or Banamine® pour-on. There are also natural alternatives in the form of herbal tinctures or homeopathic remedies. Going forward, please work with your veterinarian to create a plan for treating cattle for pain and/or fever that does not use aspirin.
Although NOP rules allow the use of aspirin, we can no longer recommend its use in organic livestock as FDA authority supersedes that of USDA/NOP in matters regarding food safety. We haven't yet been informed of how certification agencies will handle this apparent discrepancy.
A major concern for all involved with dairy (both organic and conventional) should be the avoidance of "drug" residues in milk. Veterinarians are tasked with the responsibility of ensuring treatments they recommend do not result in illegal residues. Veterinarians working in organic dairy should also be concerned with residues caused by natural treatments such as herbal preparations and tinctures. For this reason, I routinely recommended withholding the milk from any organic cow treated for illness for 48 hours minimum. This applies to herbal remedies, tinctures, etc.
("drug" in this case means - Any substance (other than food) used to prevent, diagnose, treat, or relieve symptoms of disease or abnormal condition.)
This article will undoubtedly raise questions by organic dairy farmers and others involved with organic dairy. The need for timely information prevents us from providing all of the details surrounding this issue. We look forward to more coverage and dialogue on this topic.
For additional information: https://www.dvm360.com/view/fda-off-label-use-of-aspirin-in-lactating-dairy-cattle-is-prohibited
Guy Jodarski, DVM, Holistic Veterinarian, can be reached at gjodarski@tds.net
Posted: to Organic Production on Sun, Nov 3, 2024
Updated: Thu, Nov 7, 2024
