CBP Proposes Changes to the In-Bond Process
Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP / www.gdlsk.com
SUMMARY: Under the U.S. Customs and Border Protection (CBP) regulations, imported merchandise may be transported in-bond. This process allows imported merchandise to be entered at one U.S. port of entry without appraisement or payment of duties and transported by a bonded carrier to another U.S. port of entry provided all statutory and regulatory conditions are met. At the destination port, the merchandise is officially entered into the commerce of the United States and duties paid, or, the merchandise is exported.
CBP is proposing various changes to the in-bond regulations to enhance CBP’s ability to regulate and track in-bond merchandise and to ensure that the in-bond merchandise is properly entered and duties are paid or that the in-bond merchandise is exported. Among other things, the proposed changes would: eliminate the paper in-bond application (CBP Form 7512).
To view the complete document --
United States, Korea Set Date for Entry Into Force of U.S.-Korea Trade Agreement
Office of the U.S. Trade Representative / www.ustr.gov
Bilateral Pact, Expected to Support Tens of Thousands of U.S. Jobs, to Take Effect March 15
Washington, D.C. – United States Trade Representative Ron Kirk announced today that the U.S.-Korea trade agreement will enter into force – that is, take effect – on March 15, 2012. This announcement follows the completion over the President’s Day weekend of work by the United States and Korea to review each other’s laws and regulations related to the implementation of the agreement. The United States has exchanged diplomatic notes with Korea in which each side confirmed that they had completed their applicable legal requirements and procedures for the agreement’s entry into force.
“In a few short weeks, the promise of the U.S.-Korea trade agreement – including tens of thousands of export-supported jobs with better wages – will start to come home for American businesses and working families,” said Ambassador Kirk. ”President Obama insisted that we get this agreement right by forging a better deal that led to strong bipartisan support in both houses of Congress. Entry into force of this agreement will open up Korea’s $1 trillion economy for America’s workers, businesses, farmers, and ranchers while also strengthening our economic partnership with a key Asia-Pacific ally.”
On March 15, almost 80 percent of U.S. exports of industrial products to Korea will become duty-free, including aerospace equipment, agricultural equipment, auto parts, building products, chemicals, consumer goods, electrical equipment, environmental goods, all footwear and travel goods, paper products, scientific equipment and shipping and transportation equipment.
Also on March 15, almost two-thirds of U.S. exports of agricultural products to Korea will become duty-free, including wheat, corn, soybeans for crushing, whey for feed use, hides and skins, cotton, cherries, pistachios, almonds, orange juice, grape juice, and wine.
The agreement also includes a number of significant commitments related to non-tariff measures that will also come into force on March 15, including obligations related to motor vehicle safety and environmental standards, enhanced regulatory transparency, standard-setting, technology neutrality, and customs administration. Strengthened protections for intellectual property rights benefiting American creators and innovators will also come into force on that day. Finally, commitments opening up Korea’s $580 billion services market will also be in effect beginning March 15.
These commitments are backed by the agreement’s strong enforcement provisions, which will enable the United States to hold Korea to its promises under the pact.
BACKGROUND
The U.S. - Korea trade agreement is an integral part of the President’s efforts to increase opportunities for U.S. businesses, farmers, ranchers, and workers through improved access for their products and services in foreign markets, and supports the President’s National Export Initiative goal of doubling of U.S. exports in 5 years. The agreement will promote the further integration of the U.S. and Korean economies and enhance the competitiveness of U.S. businesses in the world’s 12th largest economy.
In December 2010, President Obama announced the successful resolution of outstanding issues with the U.S.-Korea trade agreement, setting the stage for the ratification of an agreement estimated to support 70,000 American jobs from increased goods exports alone, with additional jobs potential from the further opening of Korea’s large services market to American firms, and other measures.
The U.S.-Korea trade agreement’s implementing bill, approved by Congress in October 2011, authorizes the President to exchange notes with Korea providing for the entry into force at such time as the President determines that Korea has taken measures necessary to comply with provisions of the agreement that are to take effect on the date of the entry into force.
CPSC Adopts New Federal Standard for Portable Bed Rails
Consumer Product Safety Commission / www.cpsc.gov
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) voted (4-0) to adopt a new federal standard to make portable bed rails safer for children. A portable bed rail is used on the side of an adult bed to keep children, typically age 2 to 5 years old, from falling out of the bed.
The mandatory standard contains safety requirements for bed rails and addresses consumer assembly and installation problems that have resulted in child deaths. CPSC staff worked closely with the standards development organization ASTM International to update its consensus standard. CPSC's new mandatory standard incorporates ASTM's bed rail standard F2085-12.
The federal standard for portable bed rails includes the following requirements:
- Portable bed rails must not create a dangerous gap with the mattress into which a child can fall.
- They must be tested to make sure the bed rail hardware is permanently attached, and that the components cannot be assembled in an unsafe manner.
- Bed rails must have improved warnings on labels and instructions.
- Installation components, such as anchor or straps, must be permanently attached to the bed rail. These component parts also must have a warning label on them.
- Bed rails must not have hazardous sharp edges, points or small parts.
The improved warnings explicitly state that bed rails should never be used with children younger than two years old. They are intended for children age 2 to 5 who can get out of an adult bed without help. Gaps in and around bed rails have entrapped young children and killed infants.
The federal standard will go into effect six months after publication of the final rule in the Federal Register.
In addition to portable bed rails, the Commission has approved mandatory standards for other children’s products, including cribs, bath seats, baby walkers and toddler beds, as required by Congress in Section 104 of the Consumer Product Safety Improvement Act of 2008.
FTC Halts Deceptive Practices of Marketer Who Collected $359 Million Using Bogus 'Free' Trial Offers
Federal Trade Commission / www.ftc.gov
Settlements Ban Defendants From Using 'Negative-Option' Marketing.
The Federal Trade Commission has stopped an Internet scheme that allegedly used bogus "free" product offers that deceived consumers in the United States and other countries and charged them for products and services they did not want or agree to purchase. A settlement order, reached as part of the FTC's ongoing efforts to stamp out online marketing fraud, permanently bans Jesse Willms and his companies from using "negative-option" marketing, a practice in which the seller interprets consumers' silence or inaction as permission to charge them. The Willms settlement order imposes a judgment of $359 million that will be suspended upon Willms's surrender of bank account funds and proceeds from the sale of his house, personal property, and corporate assets, including a Cadillac Escalade, fur coat, and artwork.
"The fact that almost four million consumers fell prey to the lure of these 'free trial' offers is a stark reminder that 'free' offers can come at a huge price," said David Vladeck, Director of the FTC's Bureau of Consumer Protection. "The FTC has stopped about $1 billion in online marketing fraud during the past two years by shutting down operations like this. But consumers still need to beware, because scam artists are constantly coming up with new ways to deceive people online."
The FTC worked closely with Canadian law enforcement, including the Alberta Partnership Against Cross-Border Fraud and the Canada Competition Bureau, in investigating this international scheme. Most of the defendants are located in Alberta.
"International collaboration is increasingly important for enforcement agencies combating deceptive practices online," said Lisa Campbell, Deputy Commissioner of Competition for the Competition Bureau. "The Bureau worked with the FTC as part of our ongoing investigation into alleged misleading representations by Mr. Willms and his companies."
According to the FTC's complaint, filed in May 2011, Willms and his companies lured consumers with "free" trial offers for weight-loss pills, teeth whiteners, health supplements, a work-at-home scheme, access to government grants, free credit reports, and penny auctions. Consumers were often charged for the "free" trial, a monthly recurring fee, typically $79.95, and additional monthly recurring fees for so-called "bonus" offers. The defendants allegedly contracted with affiliate marketers whose banner ads, pop-ups, sponsored search terms, and unsolicited e-mail led consumers to the defendants' websites, and paid the affiliates for each consumer whose credit or debit card was charged. The agency filed an amended complaint, in September 2011, to add two defendants.
The Willms settlement order also permanently prohibits Willms and his 11 companies from:
- debiting consumers' bank accounts without first obtaining their express verifiable authorization;
- misrepresenting any product or service or the terms and conditions associated with any offer, specifically including claims of "free," "risk-free," or "trial offer;"
- failing to clearly disclose the terms and conditions of any offer, including refund terms, before requesting consumers' payment information;
- making misleading or unsubstantiated disease-prevention, weight-loss, and other health-related claims;
- using false or deceptive endorsements and testimonials;
- failing to monitor the activities of marketing affiliates and affiliate networks involved in the marketing of any Willms product or service; and
- making misrepresentations in order to obtain services from payment processors, banks, and other third parties.
In addition to Willms and his companies, five individuals who allegedly provided services to Willms have entered into separate settlements with the FTC. Peter Graver, Adam Sechrist, Brett Callister, Carey L. Milne, and Elizabeth Graver are permanently prohibited from making misrepresentations in order to obtain services from payment processors, banks, and other third parties. The amended complaint alleged that these defendants, along with Willms, had provided merchant banks with false or misleading information to obtain and maintain merchant accounts through which Willms placed charges on consumers' credit and debit card accounts.
The settlement orders against these individuals also impose monetary judgments of varying amounts. The judgment against Peter Graver will be suspended upon his payment of $20,000. The order against Elizabeth Graver imposes a $38,000 judgment that is not suspended. The judgments against Sechrist, Callister, and Milne are suspended due to their inability to pay. If any of the defendants is found to have misrepresented his or her financial condition or fails to meet the monetary terms of his or her order, the full judgment in the order will become due immediately.
The FTC would like to thank the Canada Competition Bureau, Service Alberta, the Royal Canadian Mounted Police, the Alberta Partnership Against Cross Border Fraud, the Edmonton Better Business Bureau, and the BBB of Southern Nevada for their invaluable assistance in this investigation.
The Commission vote approving the proposed consent orders was 4-0. The FTC filed the orders in the U.S. District Court for the Western District of Washington at Seattle on February 22, 2012. The orders will become final when approved and signed by the District Court judge.
To help consumers avoid the hidden costs in some "free trial" programs, an FTC video, Free Trial Offers, tells how to check out a free trial before you sign up and what to do if you find yourself enrolled in a free trial offer without your permission. The video is also available at youtube.com/ftcvideos. For more information, click "Free Trials" Aren't Always Free" and Taking Charge: What To Do If Your Identity Is Stolen.
NOTE: These consent orders are for settlement purposes only and do not constitute an admission by the defendants that the law has been violated. Consent orders have the force of law when approved and signed by the District Court judge.
FDA NEWS RELEASE: FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
Department of Transportation / www.dot.gov
Announcements build on President Obama’s Executive Order
The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.
“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”
In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the U.S. For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks. For methotrexate, in addition to already announced actions, the Agency has approved a new manufacturer of preservative-free formulation of methotrexate that is expected to further bolster supply and help avert a shortage of this lifesaving medicine. FDA expedited review of the application to help address this potential shortage.
In addition, in response to President Obama’s Executive Order on prescription drug shortages, FDA today issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption. Increased awareness of the importance of early notification due to President Obama’s Oct. 31, 2011, Executive Order and FDA’s letter to manufacturers1 on the same day has resulted in a sixfold increase in voluntary notifications by industry of potential shortages. In 2011, there were a total of 195 drug shortages prevented. Since the Executive Order, FDA has prevented 114 drug shortages.
Under FDA’s exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil. Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi’s sarcoma and multiple myeloma. FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs.
FDA’s exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd.
Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs.
When a company is identified that is willing and able to import the needed drug product, FDA evaluates the foreign-approved drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients. Only after successful evaluation of these factors does FDA exercise its enforcement discretion for the temporary importation of an overseas drug into the U.S. market.
With regard to methotrexate, a drug that is needed for the treatment of many forms of cancer and other serious diseases, FDA has successfully engaged many firms to assist in maintaining supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with acute lymphocytic leukemia (ALL) and for the high-dose therapy of osteosarcoma.
First, FDA has prioritized review of and approved a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals and expects that product to become available in March and continue indefinitely. Second, Hospira expedited release of additional supplies, resulting in 31,000 vials of new product – enough for more than one month’s worth of demand – being shipped to hundreds of U.S. hospitals and treatment centers today. FDA is actively working with other manufacturers of methotrexate who have also stepped up to increase production in order to meet patient needs, including Mylan and Sandoz Pharmaceuticals.
APP’s application for preservative-free methotrexate is a supplement to its already approved generic drug application that the firm had previously discontinued. When FDA became aware of potential problems with the supply of the drug (due to the largest manufacturer, Bedford/Ben Venue voluntarily closing its plant), the Agency reached out to other firms to see how FDA could assist to meet the shortfall.
Prior to approval of APP’s application and subsequent to Ben Venue’s voluntary shutdown, FDA worked with Ben Venue on release of already manufactured preservative-free methotrexate, following confirmation of its safety. This supply is available already and will provide emergency supplies as the other firms also work to increase production of methotrexate in response to requests by FDA and the public.
The Administration also announced on October 31, 2011, its support for bipartisan legislation that would require all prescription drug shortages to be reported to FDA and would give FDA new authority to enforce these requirements. While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages.
Two Drug Smuggling Mothers Busted by CBP
U.S. Customs & Border Protection / www.cbp.gov
El Paso Texas – U.S. Customs and Border Protection officers working at the El Paso port of entry made five drug busts in the last two days including two cases which involved women who were traveling with children when stopped by CBP officers.
“Unfortunately this is something that is happening more and more in the drug smuggling community,” said Hector Mancha, CBP El Paso Port Director. “Smugglers may believe that family units will not attract the scrutiny of CBP. History has shown us that smugglers come in all age groups, sexes, nationalities and even at times as families traveling together.”
CBP officers working at the Ysleta international crossing seized 23.8 pounds of cocaine shortly before 2 p.m. Wednesday. CBP officers at the port were conducting a sweep of vehicles waiting in line when drug sniffing dog “Sany” alerted to a 2005 Chevrolet Malibu. The vehicle was being driven by a 28-year-old woman who was traveling with three daughters aged nine, seven and 10 months.
CBP officers moved the vehicle to secondary exam area to continue their inspection. They used a “Buster” density meter on the vehicle and received high readings consistent with hidden contraband in the rear portion of the car. They located a hidden compartment in the rear wheel well area of the car. CBP officers removed 11 cocaine-filled bundles from the compartment.
CBP officers took custody of the driver, 28-year-old Maria Elena Estrada Garcia of Ciudad Juarez, Chihuahua, Mexico. She was turned over to U.S. Immigration and Customs Enforcement HSI special agents to face federal charges in connection with the failed smuggling attempt. She is currently detained at the El Paso County jail and being held without bond.
CBP officers working at the Bridge of the Americas international crossing seized 29 pounds of marijuana shortly after 4 p.m. Wednesday. A CBP officer at the primary inspection booth noted an anomaly in the spare tire of a 1985 Chevrolet Blazer that entered the port from Mexico. The vehicle was being driven by a 22-year-old woman who was traveling with her two-year-old son.
CBP officers moved the vehicle to secondary exam area to continue their inspection. CBP drug sniffing dog “Jive’ alerted to the spare tire. CBP officers opened the tire and removed 28 marijuana-filled bundles.
CBP officers took custody of the driver, 22-year-old Angelica Hernandez Sanchez of Tornillo, Texas. She was turned over to U.S. Immigration and Customs Enforcement HSI special agents to face federal charges in connection with the failed smuggling attempt. She is currently detained at the El Paso County jail and being held without bond.
In the last 48 hours CBP officers working at area ports made three additional marijuana seizures totaling 156 pounds. CBP officers working at area ports also recorded 19 immigration violations, apprehended three wanted people, seized prohibited medication, confiscated prohibited food products, and made one handgun and ammunition seizure. While anti-terrorism is the primary mission of U.S. Customs and Border Protection, the inspection process at the ports of entry associated with this mission routinely results in impressive numbers of enforcement actions in all categories.
Top Story: HSI Special Agents Seize $825,570 Worth of Counterfeit Goods
U.S. Customs & Immigration Enforcement / www.ice.gov
You never know what you'll find at a flea market – antiques, toys or even a deal of a lifetime. But special agents with U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) warn that those deals of a lifetime may be too good to be true.
Across the country, flea markets have become notorious hot spots for selling counterfeit goods. That was the case Feb. 13, when HSI special agents identified vendors peddling counterfeit purses, shoes and jewelry items at a flea market just outside Tampa, Fla.
"We had received tips that individuals were fraudulently selling trademarked items here," said Sue McCormick, special agent in charge of HSI Tampa.
That day, special agents seized more than 6,200 items with a manufacturer's suggested retail price of $825,570. The items falsely exhibited trademarks of Hello Kitty, Gucci, Rolex, Coach, Louis Vuitton, Nike and Perry Ellis.
"A good rule of thumb is for buyers to beware. When you purchase these items you're not getting a quality product from the trademark-holder. You're getting a substandard one," said McCormick. "You're also contributing to the loss of American jobs."
This seizure follows on the heels of an operation that took place earlier this month. On Feb. 1, HSI Tampa special agents seized nearly $1.2 million worth of fake designer purses, perfume, scarves and sunglasses from an individual already awaiting sentencing for trafficking in counterfeit goods.
ICE is the lead agency investigating intellectual property theft. The International Anti-Counterfeiting Coalition estimates that counterfeiting costs U.S. businesses between $200 and $500 billion each year and more than 750,000 American jobs.