Monday, December 19, 2022

FDA, in cooperation with state departments of agriculture in CO, LA, NM, and TX, is investigating cases of illness and death in horses.

 

FDA Cautions Horse Owners Not to Feed Recalled Lots of Top of the Rockies Alfalfa Cubes due to Reports of Illness and Death

FDA, in cooperation with state departments of agriculture in CO, LA, NM, and TX, is investigating cases of illness and death in horses.

Fast Facts

  • The U.S. Food and Drug Administration is cautioning horse owners not to feed Top of the Rockies alfalfa cubes with the date codes 111222, 111322, 111422, 111522, and 111622.
  • These alfalfa cubes have been recalled by Manzanola Feeds of Manzanola, CO, which distributes products directly to feed stores and co-ops in 10 states. Further distribution is possible, so it’s important to check the date codes if you have these products.
  • Top of the Rockies alfalfa cubes are sold in white and tan plastic 50-pound bags with green labeling. The date codes are on the front of the package.
  • If you have Top of the Rockies alfalfa cubes with these date codes, or you can’t be sure of the date code of the products you have, throw them away in a secure container and follow the handling and cleaning instructions below.
  • FDA is aware of at least 98 horses in Colorado, Louisiana, New Mexico, and Texas who showed neurologic symptoms. At least 45 of these horses have died or were euthanized due to declining health.
  • The symptoms reported are consistent with botulism, and while further testing is underway to pinpoint the cause of the horse illnesses, horse owners and handlers should take precautions to protect human and animal health.
  • Immediately consult a veterinarian if your horse ate this product and shows signs of neurologic illness, such as muscle tremors, difficulty eating or swallowing, difficulty standing, or collapse.
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Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You

https://www.fda.gov/consumers/consumer-updates/some-imported-dietary-supplements-and-nonprescription-drug-products-may-harm-you?utm_medium=email&utm_source=govdelivery 

 

Tuesday, December 13, 2022

FDA warns consumers about fraudlent products relating to flu-There Are No FDA-Approved Homeopathic Products

 

Avoid using imported medicines, especially for children. Medications from other countries might not have been evaluated for safety and effectiveness. These products may be addictive or contain other dangerous ingredients.

The fall and winter flu season may bring out dishonest sellers hawking fraudulent products to unsuspecting consumers.

Some of these sellers illegally offer unproven products that claim to prevent, mitigate, treat, or cure the flu – even though they have not been evaluated or approved by the U.S. Food and Drug Administration for safety and effectiveness. These products can be found online, including popular marketplaces, and in retail stores. They may be labeled as dietary supplements, foods, hand sanitizers, nasal sprays, or devices.

These products might be dangerous to you and your family. The FDA urges consumers to avoid fraudulent flu products and offers some tips on how to spot them.

A Flu Vaccine Is the Best Prevention

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Getting a flu vaccine is the best way to prevent this infectious disease and its serious complications.

The Centers for Disease Control and Prevention recommend that everyone age 6 months and older get vaccinated every year against influenza. This is particularly so for people at an increased risk for serious complications, including young children, adults 65 years and older, and those with chronic medical conditions. For more information on flu vaccine recommendations, visit this CDC page.

The FDA has approved numerous vaccines for the prevention of influenza. To find a flu vaccine near you, visit this page.

FDA-Approved Antiviral Medications for Flu

If you do get the flu, there are FDA-approved antiviral drugs, available by prescription from your health care professional, to treat it. There are several FDA-approved antiviral drugs recommended by the CDC for use against circulating influenza viruses. These drugs work best if started soon after the onset of symptoms (within 48 hours).

Flu antiviral medications are used to prevent or treat flu and are available by prescription in the form of pills, liquids, inhalers, and intravenous infusion. The various products are all approved for adolescent and adult use, and they differ in the ages for which they are approved to treat infants and children, ranging from 2-weeks-old to age 12.

If you get the flu, antiviral medications can make your illness milder and may make you feel better faster. Antiviral medications work best when started within the first two days of getting sick.

If you are exposed to the flu, antiviral medication can help prevent you from becoming sick. Talk to your health care professional if you have been or may be near a person with the flu.

If you think you have the flu, talk to your health care professional. There are FDA-approved drugs to help with the flu.

Types of Fraudulent Flu Products

There are no legally marketed over-the-counter (OTC, or non-prescription) drugs to prevent, treat, or cure the flu. But there are legally marketed OTC drugs to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.

Dietary supplements, conventional foods (such as some herbal teas), or devices (such as certain air filters and light therapies) that fraudulently claim to prevent, mitigate, treat, or cure the flu have not been evaluated by the FDA for safety and effectiveness.

The FDA is particularly concerned that fraudulent products might cause people to delay, forgo, or stop the medical treatment they need, leading to serious and life-threatening harm. The ingredients in fraudulent products could lead to unexpected side effects and interactions with other medications people may be taking.

Protect yourself and your family by looking out for potentially fraudulent flu and antiviral products being sold without a prescription, which may claim to:

  • Reduce the severity and length of flu or other viral infections.
  • Boost your immunity naturally without a flu vaccine.
  • Act as a safe and effective alternative to the flu vaccine.
  • Prevent catching the flu or viral infections.
  • Be an effective treatment for flu or viral infections.
  • Provide faster recovery from the flu or viral infections.
  • Support your body’s natural immune defenses to fight off flu or other viruses.

Find Out if Your Online Pharmacy Is Safe

Fraudsters take advantage of unsuspecting people through websites appearing to be online pharmacies selling prescription drugs.

Legitimate online pharmacies do exist. But so do many websites that look like safe online pharmacies but are actually fraudulent and engaging in illegal activity. These websites may be selling unapproved drugs that may be dangerous.

Unsure about an online pharmacy? Visit the FDA’s BeSafeRx campaign to learn how to safely buy prescription medicines online. If you have a question about a treatment or product, talk to your doctor or other health care professional.

There Are No FDA-Approved Homeopathic Products

At your pharmacy and online, you may see products being sold and advertised as homeopathic. The FDA is not aware of any proven benefits of these products.

Homeopathic products are generally labeled as containing very small amounts of highly diluted substances, including ingredients from plants, animal or human sources, bacteria, minerals, and chemicals. The FDA has found that some of these products contain active drug ingredients in levels that far exceed the amount stated on the product’s label and could cause significant harm to children. Therefore, we urge caution if you are thinking about giving homeopathic flu, cough, and cold medicines to children.

There are no FDA-approved homeopathic products. Homeopathic products sold in the U.S. have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness, and quality.

Friday, December 9, 2022

 Department of Justice

U.S. Attorney’s Office
Southern District of New York

FOR IMMEDIATE RELEASE
Friday, December 9, 2022

Thoroughbred Racehorse Trainer Jason Servis Pleads Guilty In Federal Doping Case

Racehorse Trainer Jason Servis Acquired, Distributed, and Directed Others to Administer Prohibited Performance Enhancing Drugs to Racehorses

Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant JASON SERVIS pled guilty today for his role in the distribution of adulterated and misbranded drugs intended for administration on racehorses he trained, in connection with the charges filed in United States v. Navarro et al., 20 Cr. 160 (MKV).  SERVIS pled guilty before U.S. District Judge Mary Kay Vyskocil.  SERVIS will be sentenced by Judge Vyskocil on May 18, 2023.

U.S. Attorney Damian Williams said: “Servis’ conduct represents corruption at the highest levels of the racehorse industry.  As a licensed racehorse trainer, Servis was bound to protect the horses under his care and to comply with racing rules designed to ensure the safety and well-being of horses and protect the integrity of the sport.  Servis abdicated his responsibilities to the animals, to regulators, and to the public.  This latest conviction demonstrates the commitment of this Office and of our partners at the FBI to the prosecution and investigation of corruption, fraud, deceit, and endangerment in the racehorse industry.”

According to the allegations contained in the Superseding Indictment, the Superseding Information charging SERVIS, prior charging instruments and other filings in this case, and statements during court proceedings:

The charges in the Navarro case arise from an investigation of widespread schemes by racehorse trainers, veterinarians, performance enhancing drug (“PED”) distributors, and others to manufacture, distribute, and receive adulterated and misbranded PEDs and to secretly administer those PEDs to racehorses competing at all levels of professional horseracing.  By evading PED prohibitions and deceiving regulators and horse racing officials, participants in these schemes sought to improve race performance and obtain prize money from racetracks throughout the United States and other countries, including in New York, New Jersey, Florida, Kentucky, and Saudi Arabia, all to the detriment and risk of the health and well-being of the racehorses.  Trainers, like SERVIS, who participated in the schemes stood to profit from the success of racehorses under their control by earning a share of their horses’ winnings and by improving their horses’ racing records, thereby yielding higher trainer fees and increasing the number of racehorses under their control.

SERVIS ordered hundreds of bottles of the drug “SGF-1000,” which was compounded and manufactured in unregistered facilities and contained growth factors that the defendant believed to be undetectable through regular drug screens.  Virtually all the horses in SERVIS’ barn received that drug, including the thoroughbred racehorse “Maximum Security,” who crossed the finish line first at the 2019 Kentucky Derby.  SGF-1000 was an intravenous drug promoted as, among other things, a vasodilator capable of promoting stamina, endurance, and lower heart rates in horses through the purported action of “growth factors.”  SERVIS approved veterinary bills to racehorse owners that contained concealed charges for SGF-1000, which were falsely billed under the line item “Acupuncture & Chiropractic.”  In September 2019, the New York State Gaming Commission released an advisory stating that SGF-1000 was prohibited under the racing rules and had been prohibited since 2012.  SERVIS continued to allow the administration of that drug on the horses he trained up until his arrest in March 2020.

Horses trained by SERVIS were regularly administered the prescription drug “Clenbuterol” with no valid prescription, which was part of a deliberate effort to conceal that conduct from racing regulators and avoid mandatory reporting requirements.

SERVIS further obtained and transported a misbranded version of “Clenbuterol,” which he obtained from convicted co-defendant JORGE NAVARRO.

*                *                *

Mr. Williams praised the outstanding investigative work of the Federal Bureau of Investigation New York Office’s Eurasian Organized Crime Task Force and its support of the Bureau’s Integrity in Sports and Gaming Initiative.  Mr. Williams also thanked the Food and Drug Administration for their assistance.

This case is being handled by the Office’s Money Laundering and Transnational Criminal Enterprises Unit.  Assistant U.S. Attorney Sarah Mortazavi is in charge of the prosecution.

Topic(s): 
Financial Fraud
Contact: 
Nicholas Biase (212) 637-2600
Press Release Number: 
22-381
Updated December 9, 2022

 

Thoroughbred Racehorse Trainer Jason Servis Pleads Guilty In Federal Doping Case

Racehorse Trainer Jason Servis Acquired, Distributed, and Directed Others to Administer Prohibited Performance Enhancing Drugs to Racehorses

Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant JASON SERVIS pled guilty today for his role in the distribution of adulterated and misbranded drugs intended for administration on racehorses he trained, in connection with the charges filed in United States v. Navarro et al., 20 Cr. 160 (MKV). SERVIS pled guilty before U.S. District Judge Mary Kay Vyskocil. SERVIS will be sentenced by Judge Vyskocil on May 18, 2023.

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Mark Cuban Cost Plus Drug partners with employer group

Mark Cuban Cost Plus Drugs and a company founded by the Purchaser Business Group on Health launched a supplemental drug discount health plan benefit for employers.

 
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Wednesday, December 7, 2022

Note of Caution to Compounding Pharmacies

 Note of Caution to Compounding Pharmacies | BakerHostetler - JDSupra

 

MN Board of Pharmacy files lawsuit against companies selling ...

2 days ago — The Minnesota Board of Pharmacy on Monday announced the filing of a civil lawsuit​ against some Moorhead-based THC edibles manufacturers and retailers.