CITES Trade Suspension with Mexico - Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP
On March 27, 2023, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) announced the suspension of all commercial trade in CITES species to/from Mexico, effective immediately.
The U.S. Endangered Species Act prohibits trade in specimens contrary to CITES, including the import, export, and re-export of any CITES species subject to a trade suspension. Effective immediately, all shipments containing CITES specimens traded for commercial purposes under an import permit, export permit, or re-export certificate issued by Mexico for the species, are subject to the enforcement action.
Please contact John A. Schoenig, [212-973-7762 or JSchoenig@gdlsk.com], or any of our other attorneys, with any questions you may have.
CSMS # 55701614 - (UPDATED) GUIDANCE: Delay of Section 232 Aluminum Smelt and Cast Reporting Requirements - U.S. Customs & Border Protection
The new requirements for reporting the countries of smelt and cast for imports of aluminum and aluminum derivative products effective on April 10, 2023 have been delayed thirty days until May 10, 2023. This will allow additional time for the trade to update their software programming and systems to comply with these new reporting requirements.
There is no change to the April 10, 2023 effective date of the 200 percent duties on imports of aluminum and derivative aluminum articles that are products of Russia, or where any amount of primary aluminum used in the manufacture of such aluminum articles is smelted in Russia, or where such aluminum articles are cast in Russia.
On February 24, 2023, the President issued Presidential Proclamation 10522 on Adjusting Imports of Aluminum into the United States, providing for 200 percent import duties on aluminum and derivative articles that are the products of Russia (effective March 10, 2023) and that are smelted or cast in Russia (effective April 10, 2023). The Proclamation also requires that importers shall provide to U.S. Customs and Border Protection (CBP) information necessary to identify the countries where the primary aluminum used in the manufacture of aluminum and derivative articles imports are smelted and cast. See 88 FR 13267 issued on March 2, 2023.
NEW EFFECTIVE DATE FOR REPORTING SMELT AND CAST COUNTRIES
Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on May 10, 2023, importers of all aluminum articles and aluminum derivative articles from all countries of origin (except the U.S.), regardless of whether Section 232 duties, quotas, exclusions, or general approved exclusion apply, shall report the primary country of smelt, secondary country of smelt, and country of cast on the entry summary.
Federal Register Notices:
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Alloy and Certain Carbon Steel Threaded Rod From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2021-2022
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Robotic Floor Cleaning Devices and Components Thereof; Notice of Commission Final Determination Finding a Violation of Section 337; Issuance of a Limited Exclusion Order and Cease and Desist Orders; Termination of the Investigation
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Carbon and Alloy Steel Wire Rod From Italy: Final Results of the Expedited First Sunset Review of the Countervailing Duty Order
• Antidumping and Countervailing Duty Orders on Certain Aluminum Foil From the People's Republic of China: Preliminary Affirmative Determinations of Circumvention With Respect to the Republic of Korea and the Kingdom of Thailand; Correction
• Investigations; Determinations, Modifications, and Rulings, etc.: Certain Automated Retractable Vehicle Steps and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting a Motion To Amend the Complaint and Notice of Investigation
• Certain Smart Thermostat Hubs, Systems Containing the Same, and Components of the Same; Notice of a Commission Determination Not To Review an Initial Determination Granting a Motion To Terminate the Investigation Based on Withdrawal of the Complaint; Termination of the Investigation
• Certain Cellular Base Station Communication Equipment, Components Thereof, and Products Containing Same; Notice of Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on Settlement; Termination of the Investigation
• Certain Mobile Phones, Tablet Computers, Smart Watches, Smart Speakers, and Digital Media Players, and Products Containing Same; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on Settlement and To Vacate as Moot an Initial Determination Granting Summary Determination That the Economic Prong of the Domestic Industry Requirement Is Satisfied; Termination of the Investigation
• Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Tool Chests and Cabinets From the People's Republic of China: Final Results of the Expedited First Sunset Review of the Countervailing Duty Order
• Stainless Steel Sheet and Strip From the People's Republic of China: Final Scope Ruling and Final Affirmative Determination of Circumvention for Exports From the Socialist Republic of Vietnam
United States and Japan Sign Critical Minerals Agreement - Office of United States Trade Representative
Historic agreement will diversify key supply chains and strengthen the U.S.-Japan bilateral economic and trade relationship
WASHINGTON -- United States Trade Representative Katherine Tai and Japan’s Ambassador to the United States, Tomita Koji, today signed a critical minerals agreement (“Agreement Between the Government of Japan and the Government of the United States of America on Strengthening Critical Minerals Supply Chains”). The Agreement builds on the 2019 U.S.-Japan Trade Agreement and will strengthen and diversify critical minerals supply chains and promote the adoption of electric vehicle battery technologies. In particular, the Agreement memorializes the shared commitment of the United States and Japan with respect to the critical minerals sector to facilitate trade, promote fair competition and market-oriented conditions for trade in critical minerals, advance robust labor and environmental standards, and cooperate in efforts to ensure secure, transparent, sustainable, and equitable critical minerals supply chains.
“Today’s announcement is proof of President Biden’s commitment to building resilient and secure supply chains,” said Ambassador Katherine Tai. “Japan is one of our most valued trading partners and this agreement will enable us to deepen our existing bilateral relationship. This is a welcome moment as the United States continues to work with our allies and partners to strengthen supply chains for critical minerals, including through the Inflation Reduction Act.”
The Agreement establishes several new commitments and areas for joint cooperation regarding electric vehicle battery critical minerals supply chains between the United States and Japan, including those related to:
• Non-imposition of export duties on critical minerals;
• Domestic measures to address non-market policies and practices of other countries affecting trade in critical minerals;
• Best practices regarding review of investments within their territories in the critical minerals sector by foreign entities;
• Measures that promote more resource efficient and circular economy approaches to reduce the demand for, and environmental impact of, virgin material extraction and related processes;
• Engagement, information-sharing, and enforcement actions related to labor rights in critical minerals extraction and processing;
• Remedying violations of labor rights at entities connected to critical minerals supply chains; and
• Promoting employer neutrality in union organizing and operations.
The Agreement entered into force immediately upon signature.
Dangerous prohibited items seized by Minnesota CBP before they enter U.S. - U.S. Customs & Border Protection
MINNEAPOLIS — At an Express Consignment Operations (ECO) hub near Minneapolis – Saint Paul International Airport (MSP), U.S. Customs and Border Protection (CBP) agriculture specialists intercepted three shipments containing dangerous prohibited items arriving from overseas.
On March 21, agriculture specialists inspected three packages arriving from Hong Kong, Laos, and Thailand. The first shipment was manifested as a ceramic plate, but inspection of the shipment revealed food items. While most were enterable food items with no agriculture concerns, approximately 7 pounds of prohibited beef and pork sausage.
The second shipment from Laos, contained 16 pounds of prohibited material, such as tubers and root stock that required phytosanitary certification. The items were removed and examined for pests. However, a deeper dive into the package uncovered a layer of wood chips that concealed a dried animal skin. The animal skin was removed from the shipment and referred to Fish and Wildlife Services (FWS). FWS inspector identified the skin as badger and detained the skin.
The third shipment from Thailand was manifested as dried bamboo shoot but contained an animal skin. Further inspection by agriculture specialist found the animal skin to be water buffalo skin, which is prohibited.
All prohibited items were destroyed in accordance with the U.S. Department of Agriculture. All the shipments were addressed to various locations in Minnesota. Additionally, all the recipients were notified that their shipments were either seized or had prohibited items removed. CBP officers and agriculture specialists are stationed at ECOs around the nation and conduct inspections to ensure imported goods meet U.S. admissibility regulations.
"Our nation's food supply is constantly at risk from pests and disease not known to occur in the U.S.,” said LaFonda D. Sutton-Burke, Director, Field Operations-Chicago Field Office. “These significant interceptions by our Agriculture Specialists at the ECO at MSP exemplify CBP's continued commitment to safeguarding American agriculture."
CBP recommends that people who wish to import plant materials, animal materials and other agricultural items consult the CBP Information Center section on the CBP website or call (877) 227-5511. In addition, when traveling to the United States, travelers should always declare all items acquired abroad to CBP officers to avoid civil or criminal penalties and reduce the risk of introducing pests and disease to the United States.
“CBP’s Agriculture Specialists mitigate the threat of non-native pests, diseases, and contaminants entering the United States” said Augustine Moore, Area Port Director-Minnesota. “CBP agriculture specialists have extensive training and experience in the biological sciences and agricultural and inspect travelers and cargo arriving into the United States by air, land and sea ports of entry.
CBP's border security mission is carried out at 328 ports of entry. Please visit CBP Ports of Entry to learn more about how CBP’s Office of Field Operations secures our nation’s borders. Learn more about CBP at www.CBP.gov.
FDA Approves First Over-the-Counter Naloxone Nasal Spray - Federal Trade Commission
Agency Continues to Take Critical Steps to Reduce Drug Overdose Deaths Being Driven Primarily by Illicit Opioids
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.
The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.
The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.
Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
The FDA granted the OTC approval of Narcan to Emergent BioSolutions.
FTC Action Leads to Lifetime Industry Ban for Operators of ‘Extended Vehicle Warranty’ Scam - Federal Trade Commission
Proposed court orders prohibit defendants from all extended warranty sales and from all outbound telemarketing
As a result of a Federal Trade Commission lawsuit, the operators of a telemarketing scam that called hundreds of thousands of consumers nationwide to pitch them expensive “extended automobile warranties” will face a lifetime ban from the extended automobile warranty industry and from all outbound telemarketing.
Under the terms of proposed court orders, three companies and their owners that were charged by the FTC with running the operation that scammed consumers out of millions of dollars would be permanently banned from participating in the extended automobile warranty market, as well as from any further involvement in outbound telemarketing.
“AVP misled consumers about who they were and what they were selling and called a large number of consumers who were on the FTC’s Do Not Call List,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection. “Today’s order banning five defendants from the industry and imposing a monetary judgment of $6.6 million continues the Commission’s aggressive crackdown on telemarketing fraud.”
The FTC first charged the owners and operators of American Vehicle Protection Corporation (AVP) with violating the FTC Act and the Telemarketing Sales Rule in February 2022. In its complaint, the FTC charged that AVP made unsolicited calls in which it claimed to be affiliated with vehicle makers, and deceptively claimed their products, which cost thousands of dollars, offered “bumper to bumper” protection.
American Vehicle Protection Corp.; CG3 Solutions, Inc.; and Tony Gonzalez Consulting Group,
Inc., along with individual defendants, Tony Allen Gonzalez, and his brother, Charles Gonzalez, have agreed to the terms of the proposed court orders.
The orders also include a monetary judgment of $6.6 million, which is largely suspended based on their inability to pay. If the defendants are found to have lied to the FTC about the financial status, the full judgment would be immediately payable.
The FTC’s case against the remaining defendants in the case, Kole Consulting Group, Inc., and its owner and manager, Daniel Kole, will continue.
The Commission vote approving the stipulated final orders was 3-0-1, with Commissioner Christine S. Wilson not participating. The FTC filed the proposed order in the U.S. District Court for the Southern District of Florida.
NOTE: Stipulated final orders have the force of law when approved and signed by the District Court judge.