BY KS
UNITED STATES: Phony COVID-19 Treatment
The United States filed suit to halt the sale by a New Jersey entity of an unapproved “nano silver” product previously touted as a COVID-19 treatment, the Department of Justice announced Nov. 16.
In a civil complaint for permanent injunction filed Nov. 13, 2020 in U.S. District Court for the District of New Jersey, the United States alleged that Natural Solutions Foundation, Dr. Rima Laibow, and Ralph Fucetola sold and distributed a nano silver product that the defendants claim will cure, mitigate, treat, or prevent COVID-19. Defendants’ nano silver product purportedly contains silver particles in a solution. According to the government’s complaint, nano silver is not generally recognized as safe and effective by qualified experts for the use promoted by the defendants.
“The Department of Justice will not allow individuals to take advantage of the ongoing public health emergency by peddling unproven, unapproved drugs,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will continue to work closely with the Food and Drug Administration to halt the illegal sale of such
The complaint alleges that the defendants introduced an unapproved new drug into interstate commerce, and that the disease claims defendants make lack support from well-controlled clinical studies or other credible scientific substantiation. Additionally, the complaint asserts that, because defendants’ product does not have adequate directions for lay users, the product is misbranded.
On May 19, FDA issued a joint Warning Letter with the Federal Trade Commission notifying the defendants that they violated the Federal Food, Drug, and Cosmetic Act by, among other things, distributing unapproved new drugs and misbranded drugs in interstate commerce. According to the complaint, the defendants removed certain claims regarding the nano silver product from their public-facing websites but failed to remove others.
In two other recent actions, the Department of Justice worked with FDA and other partners to halt the sale of silver products touted as COVID-19 treatments. In May, a federal court in the Eastern District of Oklahoma entered a temporary restraining order and then a preliminary injunction against Xephyr LLC, doing business as N-Ergetics, and its owners to stop the distribution of a colloidal silver product the defendants claimed would cure, mitigate, or treat COVID-19.
In July, prosecutors obtained an indictment against Utah resident Gordon H. Pedersen alleging that he posed as a doctor to promote an ingestible silver-based product as a COVID-19 cure. In a related case, the company Pedersen previously co-owned, My Doctor Suggests LLC, agreed to plead guilty to a one-count criminal information.
The enforcement action is being prosecuted by Trial Attorney Brianna M. Gardner of the Department of Justice Civil Division’s Consumer Protection Branch, and Deputy Chief of the Government Fraud Section David Dauenheimer of the U.S. Attorney’s Office for the District of New Jersey, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA, Office of General Counsel, Department of Health and Human Services.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction against the defendants.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of New Jersey, visit its website at https://www.justice.gov/usao-nj. For information about the Department of Justice’s efforts to stop illegal COVID-19-related activity, visit https://www.justice.gov/coronavirus. For the most up-to-date information on COVID-19, consumers may visit the Centers for Disease Control and Prevention (CDC) and WHO websites.
The public is urged to report suspected fraud schemes related to COVID-19 (the Coronavirus) by calling the National Center for Disaster Fraud (NCDF) hotline (1-866-720-5721) or by e-mailing the NCDF at disaster@leo.gov.
CENTRAL AMERICA: Hurricanes Taking Their Toll
The United Nations warned of catastrophic consequences from Hurricane Iota, the second major tropical cyclone to hit Central America this month.
“We’re running out of superlatives for this Atlantic hurricane season. It’s record breaking in every sense of the word. We are currently, with Iota, on the 30th named tropical storm,” Clare Nullis, spokesperson for the World Meteorological Organization, told a regular UN news briefing in Geneva.
“Iota made landfall less than two weeks after Hurricane Eta, which was also a very strong category four hurricane, made landfall just 25 kilometers apart. So we’re having these huge impacts hitting basically the same area. Nicaragua, Honduras, other parts of Central America have not recovered from Hurricane Eta, and now they’re being slammed by this new terrific powerful hurricane,” Nullis said.
Jens Laerke, spokesperson for the U.N. Office for the Coordination of Humanitarian Affairs, said aid workers in Central America were still discovering the extent of damage from Eta and were now preparing to deal with a second potentially catastrophic impact.
“Iota, with its strong winds and very heavy rainfall, can cause life-threatening flash flooding, river flooding and landslides, not least because the soil is already saturated by Eta.”
Estimates of damage from Eta were still going up as officials and local authorities gradually got access to the most affected areas, Laerke said.
“So, for example, Honduras, authorities now report that 3 million people are affected. That’s 1 million more than the figures that they reported last week. In Guatemala, we are talking about more than 900,000 people directly affected by Eta. That’s nearly triple the figure from the previous weeks. So this is very much still developing emergency on top of which now slams another emergency with potentially catastrophic consequences.”
CARIBBEAN: Over $1 Million in Cocaine Seized
Coast Guard Cutter Joseph Doyle (WPC-1133) transferred custody of four suspected smugglers and 50 kilograms of seized cocaine to Caribbean Corridor Strike Force federal agents at Sector San Juan Nov. 13, following the interdiction of a drug smuggling go-fast vessel in the Caribbean Sea.
The interdiction was the result of multi-agency efforts in support of U.S. Southern Command’s enhanced counter-narcotics operations in the Western Hemisphere, the Organized Crime Drug Enforcement Task Force (OCDETF) program and the Caribbean Corridor Strike Force (CCSF). The United States Attorney’s Office for the District of Puerto Rico is leading the prosecution for this case.
Estimated wholesale value of the seized cocaine is more than $1.4 million.
“The performance of the Coast Guard units involved in this case along with the close collaboration of our local and federal law enforcement partners resulted in a successful interdiction,” said Cmdr. Beau Powers, Sector San Juan chief of response. “This contraband will never reach the streets due to our strong partnerships and shared resolve are crucial to safeguarding the nation’s southernmost maritime border and protecting our fellow citizens in Puerto Rico and the U.S. Virgin Island from this threat.”
The bust occurred during the early morning hours of Oct. 17, 2020, after the aircrew of a Coast Guard HC-144 Ocean Sentry aircraft from Air Station Miami detected a suspicious 25-foot go-fast vessel northwest of Aguadilla, Puerto Rico.
Coast Guard Cutter Charles David Jr. (WPC-1107) responded to the sighting and interdicted the go-fast vessel with the assistance of the cutter’s small boat. After the interdiction, the Coast Guard boarding team located and recovered one bale of suspected contraband, which tested positive for cocaine.
The crew of the cutter Charles David Jr. embarked the seized contraband and the four men from the go-fast vessel, all of whom claimed Dominican Republic nationality. The Coast Guard Cutter Joseph Doyle (WPC-1133) later embarked and transported the seized contraband and suspected smugglers to San Juan, Puerto Rico, where Caribbean Corridor Strike Force federal law enforcement agents received custody.
Cutters Charles David Jr. and Joseph Doyle are 154-foot fast response cutters respectively homeported in Key West Fla. and San Juan, Puerto Rico.
EUROPE / AFRICA: Boosting Police Reform
The European Union (EU) is maintaining its commitment to the security of the people of the Democratic Republic of the Congo (DRC) by earmarking €20 million (euros) from the 11th European Development Fund for the Police Reform Support Program over five years. This brings EU support for police reform up to a total of €60 million.
European Commissioner for International Partnerships, Jutta Urpilainen, said: “There can be no development and sustainable growth without a more peaceful environment. That is why the European Union is stepping up its support for security, peace and stability in the DRC. We are therefore backing the DRC’s government in its determination to continue the security, defense and justice reforms now under way, with full respect for human rights.”
The resumption of police reform is of paramount importance to increasing public confidence in the security forces and supporting the rule of law throughout the Democratic Republic of the Congo.
This new European aid program is aimed at improving governance, protection for human rights and efforts to combat impunity and corruption. It has four specific objectives: improving the implementation of reforms and the accountability of the police; increasing the professionalism of the police and the criminal justice chain; improving human resource management; and, lastly, getting community policing up and running in order to restore public confidence.
Given the importance of recognizing the equality of men and women and combating gender-based violence, including sexual violence, particular attention will be paid to gender issues.
The EU support for security in the country follows on from the EUPOL DRC mission carried out from 2007 to 2014 as part of the common security and defense policy (CSDP), the first and second phases of the police reform support programs financed by the EDF (€35 million) and the Congolese National Police reform support program implemented from 2006 to 2020 with funding from the Instrument contributing to Stability and Peace (€5 million).
