Health Fraud & COVID-19: What You Need to Know
RADM Richardae Araojo is joined by CAPT Jason Humbert and Minerva Rogers from the Health Fraud Branch in the Office of Regulatory Affairs at FDA to discuss FDA's efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - March 5, 2021 Category: Medical Law Authors: FDA Source Type: alerts
Expanding Criminal Enforcement Operations Globally to Protect Public Health
FDA ’s inspections, investigations, and law enforcement operations are led by the Office of Regulatory Affairs and the Office of Criminal Investigations’s law enforcement investigators are critical to protecting public health (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - October 17, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Strategic Partnership Program Agroterrorism (SPPA) Initiative: Second Year Status Report July 2006 - September 2007
To assist in protecting the nation's food supply, the Federal Bureau of Investigation, Department of Homeland Security, U.S. Department of Agriculture, and the Food and Drug Administration have developed a joint assessment program, the Strategic Partnership Program Agroterrorism Initiative. The purpose of this initiative is to conduct a series of assessments of the food and agricultural sector in collaboration with private industry and State volunteers. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Strategic Partnership Program Agroterrorism (SPPA) Initiative
The Department of Homeland Security, U.S. Department of Agriculture), Food and Drug Administration, and the Federal Bureau of Investigation will collaborate with private industry and the States in a joint initiative, the Strategic Partnership Program Agroterrorism Initiative. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Strategic Partnership Program Agroterrorism (SPPA) Initiative Q & A
Q& A for the The Department of Homeland Security, U.S. Department of Agriculture, Food and Drug Administration, and the Federal Bureau of Investigation collaboration with private industry in a joint initiative on the Strategic Partnership Program Agroterrorism Initiative. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Strategic Partnership Program Agroterrorism (SPPA) Initiative: Key Criteria for Site Visits
The Department of Homeland Security, U.S. Department of Agriculture), Food and Drug Administration, and the Federal Bureau of Investigation will collaborate with private industry and the States in a joint initiative, the Strategic Partnership Program Agroterrorism Initiative. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
National Infrastructure Protection Plan
HSPD-7 identified 17 CI/KR sectors and designated SSAs for each of the sectors. Each sector is responsible for developing and submitting Sector-Specific Plans and sector-level performance feedback to the DHS to enable national cross-sector CI/KR protection program gap assessments. HSPD-9 establishes a national policy to defend the food and agriculture system against terrorist attacks, major disasters, and other emergencies. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
National Infrastructure Protection Program Sector-Specific Plans
The National Infrastructure Protection Plan (NIPP) provides an overall architecture for safeguarding the Nation's infrastructure and creates a comprehensive risk management framework to establish national priorities, goals, and requirements to protect critical infrastructure and key resources. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - June 7, 2019 Category: Medical Law Authors: FDA Source Type: alerts
Brian Richardson DBA “ In Tha Pink ” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil
Brian Richardson
DBA “ In Tha Pink ” , is voluntarily recalling lots with the expiration of
October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with Sildenafil and Tadalafil (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - April 8, 2019 Category: Medical Law Source Type: alerts
Nature ’ s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDE-5 Inhibitors in the Product
Nature ’ s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - January 30, 2019 Category: Medical Law Source Type: alerts
Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in Euphoric renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to re...
Source: FDA Health Fraud Alerts - April 17, 2018 Category: Medical Law Source Type: alerts
Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl sibutramine
, Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - October 6, 2017 Category: Medical Law Source Type: alerts
Genetic Edge Compounds Issues Voluntary Nationwide Recall of GEC Laxoplex Dietary Supplement Capsules Due to Presence of Anabolic Steroids
Genetic Edge Compounds is voluntarily recalling all lot codes distributed between February 2, 2015- May 2, 2017 of GEC Laxoplex dietary supplement capsules, packaged in a white plastic bottle containing 60 capsules to the retail level and consumer level. Food and Drug Administration ( “FDA”) analysis has found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - May 5, 2017 Category: Medical Law Source Type: alerts
A & H Focal Inc. Issues Nationwide Recall of 21 Products Marketed as Dietary Supplements & One Cosmetic Product Due to the Possible Presence of Undeclared Erectile Dysfunction Ingredients
A&H Focal Inc. is voluntarily recalling all lots of the following products because many of these products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e. sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making these tainted dietary supplements unapproved drugs. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - March 7, 2017 Category: Medical Law Source Type: alerts
