Tuesday, August 19, 2025

HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply U.S. Food and Drug Administration sent this bulletin at 08/19/2025 09:43 AM EDT

 The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or prevent infestations caused by the New World Screwworm (NWS). This declaration applies only to drugs for animals.

NWS infests warm-blooded animals, including livestock, pets, wildlife, and, in rare cases, humans, causing severe tissue damage and sometimes death. The risk to human health in the United States remains very low, but the potential future threat to animal populations and the food supply chain requires proactive action. Although eradicated from North America and Central America decades ago, NWS has progressed north since 2022 and is now approaching the U.S. border with Mexico. This parasite poses an emerging threat to livestock and food security, with potential impacts on both national security and animal health.

“Today we are taking decisive action to safeguard the nation’s food supply from this emerging threat,” said HHS Secretary Robert F. Kennedy, Jr. “This authorization equips FDA to act quickly, limit the spread of New World Screwworm, and protect America’s livestock.”

Currently, there are no FDA-approved drugs for NWS in the United States. The FDA through an EUA can authorize the flexible, faster use of certain animal drug products that may be approved for other purposes, or available in other countries, but not formally approved for NWS in the U.S. This ensures veterinarians, farmers, and animal health officials have timely access to the tools they need to protect pets, livestock, and the nation’s food supply.

“Thank you to my friends and partners Secretary Kennedy and Commissioner Makary who are answering the call and supporting our aggressive plan to push back and ultimately defeat this devastating pest. This emergency use authorization is another tool we can use in the fight against New World Screwworm,” said Secretary of Agriculture Brooke L. Rollins. “Our cattle ranchers and livestock producers are relying on the Trump Administration to defend their livelihoods. Stopping this pest is a national security priority and we are linking arms across President Trump’s cabinet to defend our borders and push back this threat.”

“Our priority is to safeguard both animal health and the nation’s food supply,” said FDA Commissioner Marty Makary, M.D., M.P.H. “FDA is acting swiftly and responsibly to help ensure we have the necessary tools to prevent and control New World Screwworm, minimizing risks to agriculture and public health.”

FDA will provide future guidance to veterinarians and stakeholders on the appropriate use of any products authorized for emergency use and update the New World Screwworm: Information for Veterinarians page.

Wednesday, August 13, 2025

 

Wednesday, July 30, 2025

 

 

Tuesday, July 29, 2025

The FDA must crack down on dangerous knockoff weight-loss drugs by Fred Roeder, opinion contributor - 07/27/25 12:00 PM ET

 FDA warns against compounded versions of Ozempic, Mounjaro

 

FDA rethinking block on compounding of Lilly's obesity …

1 day ago · The FDA has said it has agreed to reconsider its decision to prevent compounding pharmacies from producing and selling versions of Eli Lilly's diabetes and obesity drug tirzepatide.


 

  1. Federal judge blocks Arkansas' restrictions on pharmacy benefit ...

    1 day ago · A federal judge blocked Arkansas’ first-in-the-nation law regulating pharmacy benefit managers, stating in Monday’s order that it “likely violates” the U.S. Constitution’s commerce …

  2. Federal judge blocks Arkansas law barring pharmacy benefit …

    22 hours ago · A federal judge has temporarily blocked an Arkansas law that would have banned pharmacy benefit managers from owning pharmacies in the state. U.S.

 

CVS pharmacists' suicides in Pennsylvania spark concerns

23 hours ago · IT DOESN’T MAKE SENSE. YOU KNOW, MASON WAS ONE OF TWO CVS PHARMACISTS IN LANCASTER WHO DIED BY SUICIDE IN JUNE. AND A CVS PHARMACY …

 

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers

Agency alerts health care professionals and consumers of 7-hydroxymitragynine risks

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he U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH ) products under the Controlled Substances Act (CSA).

The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA is releasing a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.

“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”

This recommendation follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency’s concerns around the growing availability and use of 7-OH opioid products. There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods.

“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said FDA Commissioner Marty Makary, M.D., M.P.H. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”

The availability of 7-OH products is a major concern to the FDA, as consumers can easily purchase products with concentrated levels of 7-OH online and in gas stations, corner stores and vape shops. The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom. The FDA has also published educational materials for consumers to be more informed about these harmful products.

In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. Today, the FDA is also issuing a letter to health care professionals and is warning consumers about the risks associated with 7-OH products.

Under the CSA, drugs, substances and certain chemicals are placed into one of five schedules based upon their medical use, potential for abuse and safety or dependence liability. The Drug Enforcement Agency is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.

Wednesday, July 23, 2025