Veterinarian Louis Grasso and Standardbred Racehorse Trainers Richard Banca and Rene Allard Sentenced For Their Roles In Racehorse Doping Scheme

 

New York Veterinarian And Racehorse Trainers Sentenced To Prison In Federal Doping Case

Veterinarian Louis Grasso and Standardbred Racehorse Trainers Richard Banca and Rene Allard Sentenced For Their Roles In Racehorse Doping Scheme

Damian Williams, the United States Attorney for the Southern District of New York, announced that defendants LOUIS GRASSO, RICHARD BANCA, and RENE ALLARD were sentenced to 50 months in prison, 30 months in prison, and 27 months in prison, respectively, for their roles in distributing adulterated and misbranded drugs in service of a racehorse doping scheme. Each defendant previously pled guilty to felony drug misbranding and adulteration charges. U.S. District Judge P. Kevin Castel imposed the sentences in Manhattan federal court.

 

FDA Conditionally Approves First Drug to Manage Acute Onset of Pancreatitis in Dogs

Today, the U.S. Food and Drug Administration conditionally approved Panoquell-CA1 (fuzapladib sodium for injection) for the management of clinical signs associated with acute onset of pancreatitis in dogs. Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment of the disease.

Pancreatitis is a painful inflammatory disease of the pancreas that can be life-threatening and generally requires that dogs be hospitalized for treatment. In most cases, it occurs spontaneously. Common factors that increase the chance of developing pancreatitis include when dogs eat something outside of their normal diet (particularly fatty foods), treatment with certain medications, and diseases like diabetes mellitus. It is more common in certain breeds of dogs and in some dogs may become a recurring or chronic condition.

 

USP publishes final compounding chapters

https://www.avma.org › blog › usp-publishes-final-com...

5 days ago — The United States Pharmacopeia (USP), which sets pharmaceutical standards that apply to both human and veterinary medicine, has released final standards for ..

 

11/08/2022	07/12/2022	NatureLab Corp.	Division of Pharmaceutical Quality Operations II	CGMP/Dietary Supplement/Adulterated
11/08/2022	10/28/2022	Vape Crusades	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/08/2022	11/03/2022	The Anthos Group, Inc.	Center for Drug Evaluation and Research | CDER	Refusal to Provide Access to and Copying of Records
11/08/2022	09/06/2022	Third Synthesis Inc., dba Chicago Sweet Connections, Inc.	Division of Human and Animal Food Operations East VI	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
11/08/2022	11/02/2022	Omega & Delta Co., Inc.	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
11/08/2022	10/31/2022	Abraxis Bioscience LLC	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated

 The FDA recently issued a warning letter jointly with the Federal Trade Commission to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.

Fraudulent COVID-19 Products

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

Learn More

 

• On Tuesday, the FDA issued a warning letter jointly with the Federal Trade Commission to Alternative Health Distribution LLC d/b/a CannaAid for selling unapproved and misbranded products for use in treating or preventing COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
• The FDA continues to warn consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA analysis revealed these products contain hidden drug ingredients, including diclofenac, an NSAID, and dexamethasone, a corticosteroid. The FDA urges consumers taking these products to immediately talk to their health care professional to safely stop using them because suddenly stopping these drugs may be dangerous. 
  • In April 2022, the FDA notified consumers that the agency received adverse event reports, including of liver toxicity and death, associated with the use of Artri King and similarly named products. 
  • In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters on October 28, 2022, to Amazon, Walmart, and Latin Foods Market for distributing various “Artri” and/or “Ortiga” unapproved and misbranded drug products. Walmart and Latin Foods Market already issued voluntary recalls for these products.

 

11/01/2022	10/28/2022	Amazon.com, Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
11/01/2022	10/28/2022	Latin Foods Market	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded

 

11/01/2022	10/28/2022	Walmart Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
11/01/2022	09/27/2022	Lupin Limited	Center for Drug Evaluation and Research | CDER	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
11/01/2022	10/28/2022	Latin Foods Market	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded
11/01/2022	08/08/2022	Bakkavor Foods USA Inc.	Office of Human and Animal Food Operations – East Division 3	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
11/01/2022	10/18/2022	Facema, LLC.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
11/01/2022	10/05/2022	Sovereign Pharmaceuticals, LLC	Office of Pharmaceutical Quality Operations, Division II	CGMP/Finished Pharmaceuticals/Adulterated
11/01/2022	10/18/2022	McConnell Labs Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
11/01/2022	09/21/2022	ARYZ Trading LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
11/01/2022	10/21/2022	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC	Office of Pharmaceutical Quality Operations, Division II	Compounding Pharmacy/Adulterated Drug Products
11/01/2022	08/23/2022	Minuti Coffee LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)

Today, the U.S. Food and Drug Administration issued a revised draft guidance for industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.” This revised draft guidance responds to frequently asked questions about the FDA’s regulation of expanded access to investigational drugs and includes the agency’s recommendations for fulfilling new requirements of the 21st Century Cures Act and the FDA Reauthorization Act of 2017 that are related to expanded access.   Since FDA issued the “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers" final guidance in June 2016 (revised in October 2017), the agency has received questions from stakeholders related to the implementation of the regulatory requirements of the expanded access program. The revised draft guidance provides further clarification to some of the recommendations included in the 2017 guidance and includes additional recommendations about FDA’s current processes and policies regarding expanded access to investigational drugs.   FDA is providing this revised guidance in a question-and-answer format, to address the most recently asked questions and sharing recommendations to fulfill new statutory requirements.   When finalized, this guidance will replace the June 2016 (updated in October 2017) final guidance, "Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers."

 

FDA Warning

FDA continues to warn consumers not to purchase or use Artri and Ortiga products as the agency received adverse event reports, including of liver toxicity and death, associated with the use of Artri King and similarly named products. These products are promoted with unproven claims to treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

FDA analysis revealed hidden drug ingredients, including corticosteroids (diclofenac and dexamethasone). Suddenly stopping corticosteroids after long-term use or high doses can result in a serious withdrawal syndrome that includes fatigue, nausea, low blood pressure, low blood glucose levels, fever, dizziness, muscle and joint pain, and shortness of breath. Medical intervention may be necessary.

In support of public safety, and because some of these products may still be available on the market, FDA issued warning letters on October 28, 2022, to Amazon, Walmart, and Latin Foods Market for distributing various “Artri” and/or “Ortiga” unapproved and misbranded drug products. Walmart and Latin Foods Market already issued voluntary recalls for these products. 

Customers with questions about these products should discuss appropriate treatment options with their health care providers.

Learn Mor