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Federal Register Notices:

First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.

“With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international mail system. Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA is committed to empowering patients and providing them choice, but also protecting them through collaboration with our international regulatory and law enforcement partners. It is vital that we aggressively stop illicit products from entering the country that may place patients’ health at risk, and we are pleased to call the Government of India a partner in this effort.”

Operation Broadsword targeted packages entering the U.S. through an International Mail Facility (IMF) from Jan. 28 through Jan. 30. The operation was a collaboration between the FDA’s Office of Regulatory Affairs, Office of Criminal Investigations, Forensic Chemistry Center and Division of Northern Border Imports along with the Government of India’s Central Board of Indirect Taxes and Customs and Directorate of Revenue Intelligence and U.S. Customs and Border Protection.

During Operation Broadsword, investigators from both governments examined more than 800 shipments, which identified approximately 50 different FDA-regulated products, including medications intended to treat and or mitigate serious diseases, such as various forms of cancer and HIV. Many of the shipments, which included opioid drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection. Health risks are further compounded when products are sent through such third-party countries, which undermines protections afforded via regulated pharmaceutical supply chains.

The FDA believes international law enforcement cooperation is essential in the age of interconnected regulatory frameworks and systems of distribution. In September 2019, a senior-level FDA delegation traveled to India for the purpose of strengthening bilateral engagement. A series of stakeholder meetings—coordinated and facilitated by the India Office of the FDA’s Office of Global Policy and Strategy—were held at the U.S. Embassy in New Delhi as well as with the government of India’s Central Board of Indirect Taxes and Customs, the Directorate of Revenue Intelligence, and the Central Drug Standard Control Organization in support of an ongoing bilateral initiative to combat public health and safety-based crime.

“A bilateral enforcement exercise like Operation Broadsword allows us to closely work with our U.S. counterparts so as to share best practices, develop intelligence, better target suspect consignments, consignors and other bad actors at both ends,” said Balesh Kumar, director general, Directorate of Revenue Intelligence for the Government of India. “Such an exercise also has potential for long term capacity building. The Directorate of Revenue Intelligence is committed to fighting the menace of drugs and narcotics and international cooperation with agencies like the U.S. FDA can help us in our efforts towards this cause.”
Each day across the U.S., nine IMFs receive mail from more than 180 countries, and it is part of the FDA’s mission to inspect, detect and intercept illegal products, including those that are unapproved, counterfeit and/or potentially dangerous, such as illicit opioid products, counterfeit prescription drugs, medical devices, over-the-counter products, and products labeled as dietary supplements that may contain harmful ingredients. In fiscal year 2019, the FDA screened approximately 25,200 parcels, containing more than 41,000 products combined at all of its IMF facilities. The FDA detained more than 38,000 of those products, and expects to ultimately destroy more than 17,000 of those products as drugs subject to the FDA’s administrative destruction authority.

Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. In addition to health risks posed by these products, illegal online pharmacies can pose other risks to consumers. These include the risk of credit card fraud, identity theft and computer viruses.
The FDA provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy. Consumers are encouraged to report any unlawful sale of medical products online to FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products


Dulles CBP Officers Seize Steroids Shipped from the UK and Unreported Currency from South Korea - U.S. Customs & Border Protection

STERLING, Va. – U.S. Customs and Border Protection (CBP) officers seized illicit steroids in international mail and unreported currency from a traveler at Washington Dulles International Airport during the weekend.

A South Korean woman, who is a U.S. lawful permanent resident, reported to CBP officers that she possessed $500. Officers explained currency reporting requirements to the woman and she amended her declaration to report that she had $6,000. During a baggage examination, CBP officers discovered a total of $11,097 in her baggage. CBP officers seized all the currency and released the woman. She arrived on a flight from Seoul on Sunday.

It is legal to carry large sums of currency into or out of the United States. However, federal law requires that travelers who possess $10,000 or more in currency or other monetary instruments must report it all to a CBP officer at the airport, seaport, or land border crossing when entering or leaving the country. Read more about currency reporting requirements.

Consequences for violating U.S. currency reporting laws are severe; penalties may include seizure of most or all of the traveler’s currency, and potential criminal charges.

Also, while inspecting mail that arrived from London on Saturday, CBP officers seized 22 parcels that contained illicit anabolic steroids. The parcels were destined to addresses in Georgia, Florida, Massachusetts, New Jersey, New York, Pennsylvania, South Carolina, and Virginia, The combined weight of the steroids was 5,800 grams or about 12 pounds, 12 ounces.

Anabolic steroids are considered a Schedule III controlled substance and are illegal to possess in the United States without a prescription.

“Customs and Border Protection officers remain committed to intercepting dangerous and unlawful products at our nation’s borders and these anabolic steroid seizures are a testament to that commitment,” said Casey Durst, Director of Field Operations for CBP’s Baltimore Field Office. “CBP officers’ border enforcement vigilance is paramount to helping to keep our communities safe.”

All travelers, both U.S. citizens and foreign visitors, are encouraged to Know Before You Go to help ease their international arrivals inspection, and to visit CBP’s Travel website to learn more about rules governing travel to and from the U.S.

CBP uses a variety of techniques to intercept narcotics, unreported currency, weapons, counterfeit consumer goods, prohibited agriculture, and other illicit products, and to assure that global tourism remains safe and strong. On a typical day, CBP seizes an average of about $207,000 in unreported or illicit currency along our nation’s borders. Learn more about what CBP accomplishes during a typical day during 2019.

CBP's border security mission is led at our nation’s Ports of Entry by CBP officers from the Office of Field Operations. Please visit CBP Ports of Entry to learn more about how CBP’s Office of Field Operations secures our nation’s borders, or visit www.CBP.gov.


A Valentine’s Day Surprise Seizure for CBP in San Juan of 217 Pounds of Cocaine Concealed in a Flat Rack Container - U.S. Customs & Border Protection

SAN JUAN, Puerto Rico - U.S. Customs and Border Protection (CBP) seized 217 pounds (98.2 kilos) of cocaine concealed within a Flat Rack container arriving Friday on board the Santo Domingo – San Juan ferry.   The estimated value of the seized cocaine is $2.5 million.   

“Smugglers use very creative means to conceal their illicit drug loads into the international supply chain”, stated Roberto Vaquero, Assistant Director of Field Operations for Border Security in Puerto Rico and the U.S. Virgin Islands.  “Our officers’ expertise, along with the utilization of all available tools, resulted in the detection of these narcotics.  Our communities can feel safer knowing that the men and women of CBP are securing their borders.” 

On Feb.14, the CBP Contraband Enforcement Team inspected various containers arriving on the M/V Kydon,.observed various anomalies within an empty Flat Rack container.  

After a more intrusive examination, CBP Officers discovered several bricks concealed inside the Flat Rack, which tested positive to the properties of cocaine. 

CBP’s mission is to safeguard America’s borders thereby protecting the public from dangerous people and materials while enhancing the Nation’s global economic competitiveness by enabling legitimate trade and travel.  


U.S. Trustee Program Ready to Implement the Small Business Reorganization Act of 2019 - U.S. Department of Justice

The Department of Justice’s U.S. Trustee Program (USTP) is fully prepared to implement the Small Business Reorganization Act of 2019 (SBRA), which goes into effect today.  The SBRA was passed by Congress and signed into law by President Trump last August. 

“The SBRA represents an innovative effort to expedite and reduce the cost of bankruptcy for small business debtors to reorganize their debts and save their businesses,” said USTP Director Cliff White.  “The USTP has spent the past six months preparing for its implementation and is committed to ensuring that the law is carried out as intended.” 

Under the SBRA, small business debtors―defined as entities with less than about $2.7 million in debts that also meet other criteria―may voluntarily elect to proceed under a new subchapter V of chapter 11 of the Bankruptcy Code.  Among other things, subchapter V imposes shorter deadlines for completing the bankruptcy process, allows for greater flexibility in negotiating restructuring plans with creditors, and provides for a private trustee who will work with the small business debtor and its creditors to facilitate the development of a consensual plan of reorganization. 

According to Director White, the USTP’s role in these small business cases is to “appoint private trustees with business experience to serve as subchapter V trustees, minimize the need for costly litigation, and ensure compliance with the Bankruptcy Code and the expeditious resolution of cases.” 

As part of the USTP’s intensive preparation to implement the SBRA, U.S. Trustees conducted a nationwide search for qualified candidates to serve as subchapter V trustees, ultimately selecting about 250 candidates from more than 3,000 applications.  These trustees offer a diverse set of business, accounting, turn-around management, and legal skills.  In addition, the USTP developed a comprehensive manual and handbook to guide staff and subchapter V trustees in carrying out their new SBRA responsibilities; provided extensive training to staff, subchapter V trustees, bankruptcy professionals, and others interested in the new law; and coordinated with the bankruptcy courts on administrative issues to ensure a successful implementation. 

The USTP is the component of the Justice Department that protects the integrity of the bankruptcy system by overseeing case administration and litigating to enforce the bankruptcy laws. The Program has 21 regions and 90 field office locations covering 88 judicial districts. Learn more about the Program at https://www.justice.gov/ust.
 
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