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CBP Issues Region-Wide Withhold Release Order on Products Made by Slave Labor in Xinjiang - U.S. Customs & Border Protection

WASHINGTON — Effective January 13 at all U.S. ports of entry, U.S. Customs and Border Protection (CBP) will detain cotton products and tomato products produced in China’s Xinjiang Uyghur Autonomous Region.

CBP issued a Withhold Release Order (WRO) against cotton products and tomato products produced in Xinjiang based on information that reasonably indicates the use of detainee or prison labor and situations of forced labor. The agency identified the following forced labor indicators through the course of its investigation: debt bondage, restriction of movement, isolation, intimidation and threats, withholding of wages, and abusive living and working conditions.

“DHS will not tolerate forced labor of any kind in U.S. supply chains. We will continue to protect the American people and investigate credible allegations of forced labor, we will prevent goods made by forced labor from entering our country, and we demand the Chinese close their camps and stop their human rights violations,” said Acting DHS Deputy Secretary Ken Cuccinelli.

“CBP will not tolerate the Chinese government’s exploitation of modern slavery to import goods into the United States below fair market value,” said CBP Acting Commissioner Mark A. Morgan. “Imports made on the cheap by using forced labor hurt American businesses that respect human rights and also expose unsuspecting consumers to unethical purchases.”

This WRO will direct CBP personnel at all U.S. ports of entry to detain cotton products and tomato products grown or produced by entities operating in Xinjiang. These products include apparel, textiles, tomato seeds, canned tomatoes, tomato sauce, and other goods made with cotton and tomatoes. Importers are responsible for ensuring the products they are attempting to import do not exploit forced labor at any point in their supply chain, including the production or harvesting of the raw material.  

In July 2020, the U.S. Government issued an advisory to caution businesses about the reputational, financial, and legal risks of forced labor in Xinjiang, where the Chinese government continues to execute a campaign of repression targeting the Uyghur people and other ethnic and religious minority groups. On December 2, 2020, CBP announced the issuance of a WRO on cotton and cotton products originating from the Xinjiang Production and Construction Corps, an economic and paramilitary organization subordinate to the Chinese Communist Party.

This is the fourth WRO that CBP has issued since the beginning of Fiscal Year 2021, and the second on products originating in Xinjiang. Eight of the 13 WRO that CBP issued in Fiscal Year 2020 were on goods made by forced labor in China. All WROs are publicly available and listed by country on CBP’s Forced Labor WROs and Findings webpage.

Federal statute 19 U.S.C. 1307 prohibits the importation of merchandise produced, wholly or in part, by convict labor, forced labor, and/or indentured labor, including forced or indentured child labor. CBP detains shipments of goods suspected of being imported in violation of this statute. Importers of detained shipments have the opportunity to export their shipments or demonstrate that the merchandise was not produced with forced labor.

CBP enforces the prohibition on importing goods made by forced labor. Any person or organization that has reason to believe merchandise produced with the use of forced labor is being, or likely to be, imported into the United States can report detailed allegations by contacting CBP through the e-Allegations Online Trade Violation Reporting System or by calling 1-800-BE-ALERT.


Petitions for the Imposition of Antidumping and Countervailing Duties on R-125 Pentafluoroethane from the People's Republic of China - Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP

I. Type of Action: Antidumping Duty (“AD”):  China ; Countervailing Duty (“CVD”): China

II. Product: The merchandise covered by this investigation is pentafluoroethane (“R-125”), or its chemical equivalent, regardless of form, type or purity level. R-125 has the Chemical Abstracts Service (“CAS”) registry number of 354-33-6 and the chemical formula C2HF5. R-125 is also referred to as Pentafluoroethane, Genetron HFC 125, Khladon 125, Suva 125, Freon 125, and Fc-125. Subject merchandise includes R-125, whether or not incorporated into a blend. Subject merchandise also includes R-125 and unpurified R-125 that is processed in a third country or otherwise outside the customs territory of the United States, including, but not limited to, purifying or any other processing that would not otherwise remove the merchandise from the scope of this investigation if performed in the country of manufacture of the in-scope R-125.

Excluded from the current scope is merchandise covered by the scope of the antidumping order on Hydrofluorocarbon Blends from the People’s Republic of China. See Hydrofluorocarbon Blends from the People’s Republic of China, 81 Fed. Reg. 55436 (Aug. 19, 2016) (the “Blends Order”).

III. HTS classifications: R-125 is classified under Harmonized Tariff Schedule of the United States (HTSUS) subheading 2903.39.2035. Other merchandise subject to the current scope, including the abovementioned blends that are outside the scope of the Blends Order, may be classified under 2903.39.2045 and 3824.78.0020. The HTSUS subheadings and CAS registry number are provided for convenience and customs purposes. The written description of the scope of the petition is dispositive.

IV. Date of Filing: January 12, 2021

V. Petitioners: Honeywell International Inc.

VI. Foreign Producers/Exporters: Please contact our office for a list filed with the petition.

VII. US Importers named: Please contact our office for a list filed with the petition.

VIII. Alleged Dumping Margins (No CVD Margins Listed): China: 155.78-230.52%

IX. Comments:

A. Projected date of ITC Preliminary Conference: February 2, 2021.

B. The earliest theoretical date for retroactive suspension of liquidation for the AD is March 30, 2021; CVD is February 1, 2021. Please contact our office for a complete projected schedule for the AD/CVD investigations.

C. Volume and Value of Imports: Please contact our office for a summary of the data filed with the petition.

D. List of Alleged Subsidy Programs: Please contact our office for a list of alleged subsidy programs.

If you have questions regarding how this investigation may impact future imports of scope merchandise or whether a particular product is within the scope of the investigation, please contact one of our attorneys.


Federal Register Notices:

CBP Issues Region-Wide Withhold Release Order on Products Made by Slave Labor in Xinjiang - U.S. Customs & Border Protection

WASHINGTON — Effective January 13 at all U.S. ports of entry, U.S. Customs and Border Protection (CBP) will detain cotton products and tomato products produced in China’s Xinjiang Uyghur Autonomous Region.

CBP issued a Withhold Release Order (WRO) against cotton products and tomato products produced in Xinjiang based on information that reasonably indicates the use of detainee or prison labor and situations of forced labor. The agency identified the following forced labor indicators through the course of its investigation: debt bondage, restriction of movement, isolation, intimidation and threats, withholding of wages, and abusive living and working conditions.

“DHS will not tolerate forced labor of any kind in U.S. supply chains. We will continue to protect the American people and investigate credible allegations of forced labor, we will prevent goods made by forced labor from entering our country, and we demand the Chinese close their camps and stop their human rights violations,” said Acting DHS Deputy Secretary Ken Cuccinelli.

“CBP will not tolerate the Chinese government’s exploitation of modern slavery to import goods into the United States below fair market value,” said CBP Acting Commissioner Mark A. Morgan. “Imports made on the cheap by using forced labor hurt American businesses that respect human rights and also expose unsuspecting consumers to unethical purchases.”

This WRO will direct CBP personnel at all U.S. ports of entry to detain cotton products and tomato products grown or produced by entities operating in Xinjiang. These products include apparel, textiles, tomato seeds, canned tomatoes, tomato sauce, and other goods made with cotton and tomatoes. Importers are responsible for ensuring the products they are attempting to import do not exploit forced labor at any point in their supply chain, including the production or harvesting of the raw material.  

In July 2020, the U.S. Government issued an advisory to caution businesses about the reputational, financial, and legal risks of forced labor in Xinjiang, where the Chinese government continues to execute a campaign of repression targeting the Uyghur people and other ethnic and religious minority groups. On December 2, 2020, CBP announced the issuance of a WRO on cotton and cotton products originating from the Xinjiang Production and Construction Corps, an economic and paramilitary organization subordinate to the Chinese Communist Party.

This is the fourth WRO that CBP has issued since the beginning of Fiscal Year 2021, and the second on products originating in Xinjiang. Eight of the 13 WRO that CBP issued in Fiscal Year 2020 were on goods made by forced labor in China. All WROs are publicly available and listed by country on CBP’s Forced Labor WROs and Findings webpage.

Federal statute 19 U.S.C. 1307 prohibits the importation of merchandise produced, wholly or in part, by convict labor, forced labor, and/or indentured labor, including forced or indentured child labor. CBP detains shipments of goods suspected of being imported in violation of this statute. Importers of detained shipments have the opportunity to export their shipments or demonstrate that the merchandise was not produced with forced labor.

CBP enforces the prohibition on importing goods made by forced labor. Any person or organization that has reason to believe merchandise produced with the use of forced labor is being, or likely to be, imported into the United States can report detailed allegations by contacting CBP through the e-Allegations Online Trade Violation Reporting System or by calling 1-800-BE-ALERT.


Petitions for the Imposition of Antidumping and Countervailing Duties on R-125 Pentafluoroethane from the People's Republic of China - Grunfeld, Desiderio, Lebowitz, Silverman & Klestadt LLP

I. Type of Action: Antidumping Duty (“AD”):  China ; Countervailing Duty (“CVD”): China

II. Product: The merchandise covered by this investigation is pentafluoroethane (“R-125”), or its chemical equivalent, regardless of form, type or purity level. R-125 has the Chemical Abstracts Service (“CAS”) registry number of 354-33-6 and the chemical formula C2HF5. R-125 is also referred to as Pentafluoroethane, Genetron HFC 125, Khladon 125, Suva 125, Freon 125, and Fc-125. Subject merchandise includes R-125, whether or not incorporated into a blend. Subject merchandise also includes R-125 and unpurified R-125 that is processed in a third country or otherwise outside the customs territory of the United States, including, but not limited to, purifying or any other processing that would not otherwise remove the merchandise from the scope of this investigation if performed in the country of manufacture of the in-scope R-125.

Excluded from the current scope is merchandise covered by the scope of the antidumping order on Hydrofluorocarbon Blends from the People’s Republic of China. See Hydrofluorocarbon Blends from the People’s Republic of China, 81 Fed. Reg. 55436 (Aug. 19, 2016) (the “Blends Order”).

III. HTS classifications: R-125 is classified under Harmonized Tariff Schedule of the United States (HTSUS) subheading 2903.39.2035. Other merchandise subject to the current scope, including the abovementioned blends that are outside the scope of the Blends Order, may be classified under 2903.39.2045 and 3824.78.0020. The HTSUS subheadings and CAS registry number are provided for convenience and customs purposes. The written description of the scope of the petition is dispositive.

IV. Date of Filing: January 12, 2021

V. Petitioners: Honeywell International Inc.

VI. Foreign Producers/Exporters: Please contact our office for a list filed with the petition.

VII. US Importers named: Please contact our office for a list filed with the petition.

VIII. Alleged Dumping Margins (No CVD Margins Listed): China: 155.78-230.52%

IX. Comments:

A. Projected date of ITC Preliminary Conference: February 2, 2021.

B. The earliest theoretical date for retroactive suspension of liquidation for the AD is March 30, 2021; CVD is February 1, 2021. Please contact our office for a complete projected schedule for the AD/CVD investigations.

C. Volume and Value of Imports: Please contact our office for a summary of the data filed with the petition.

D. List of Alleged Subsidy Programs: Please contact our office for a list of alleged subsidy programs.

If you have questions regarding how this investigation may impact future imports of scope merchandise or whether a particular product is within the scope of the investigation, please contact one of our attorneys.


Federal Register Notices:

Pursuant to Executive Order (E.O.) 13873, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain,” today U.S. Department of Commerce Secretary Wilbur Ross issued an interim final rule to address the national security, economic security, and public health and safety concerns related to ICTS Transactions. The rule will ensure the resilience of, and trust in, our Nation’s ICTS supply chain, and, for the purposes of this rule, identifies six foreign governments or foreign non-government persons as foreign adversaries: the People’s Republic of China (China), the Russian Federation (Russia), the Islamic Republic of Iran (Iran), the Democratic People’s Republic of Korea (North Korea), the Republic of Cuba (Cuba), and Venezuelan politician Nicolás Maduro (Maduro Regime).

“Since day one, President Trump has been committed to protecting the national security of all Americans, and the implementation of this rule is a pivotal moment in this Administration’s efforts to put America First and hold bad actors accountable,” said Secretary Ross. “Aggressively securing the ICTS supply chain will protect American citizens and businesses from vulnerabilities that could undermine the confidentiality, integrity, and availability of their personal information or sensitive data by malicious foreign adversaries and those who wish harm on the United States.”

On May 15, 2019, President Trump issued E.O. 13873, which grants the Secretary of Commerce the authority to prohibit certain ICTS Transactions that have been “designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the jurisdiction or direction of foreign adversaries” and that pose an undue or unacceptable risk to the national security of the United States. Today’s rule allows the Department to promulgate regulations to create the processes and procedures that the Secretary of Commerce will use to identify, assess, and address certain transactions.

Today’s rule will be effective 60 days from publication, and Commerce is committed to issuing a subsequent final rule in which the Department will consider and respond to additional comments received.  In addition, the Department will implement procedures for a licensing process 120 days from publication. 

Additional Background:

The E.O. defines “foreign adversary” as “any foreign government or foreign non-government person engaged in a long-term pattern or serious instances of conduct significantly adverse to the national security of the United States or security and safety of United States persons.” 


CPSC Issues Consumer Safety Warning: Serious Injury or Death Can Occur if Lithium-Ion Battery Cells Are Separated from Battery Packs and Used to Power Devices - Consumer Product Safety Commission

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is warning consumers not to buy or use loose 18650 lithium-ion battery cells. These cells are manufactured as industrial component parts of battery packs and are not intended for individual sale to consumers.  However, they are being separated, rewrapped and sold as new consumer batteries, typically on the Internet.

The Dangers of Loose 18650 Battery Cells

Rechargeable lithium cells without proper protection that are not installed in a device or as part of an integral battery (“loose cells”) are potentially hazardous to consumers when handled, transported, stored, charged, or used to power devices.  Specifically, these battery cells may have exposed metal positive and negative terminals that can short-circuit when they come into contact with metal objects, such as keys or loose change in a pocket.  Once shorted, loose cells can overheat and experience thermal runaway, igniting the cell’s internal materials and forcibly expelling burning contents, resulting in fires, explosions, serious injuries and even death.

In addition, thermal runaway can occur in loose cells if consumers use them in inappropriate chargers that allow for charging beyond the cell’s specifications.  Unfortunately, a growing number of small consumer products, such as vaping devices, personal fans, headlamps, and some toys, are using loose 18650s as a power source.  CPSC is working with e-commerce sites, including eBay, to remove listings selling these loose cells. 

Do not use loose 18650 lithium ion cells that are separated from battery packs.  They are often misused as a stand-alone consumer battery, but do not have protection circuits.  For additional information on high-energy battery safety, please visit:
https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards/Topics/Batteries/

CPSC urges consumers to report problems with lithium-ion batteries to CPSC at: www.SaferProducts.gov.


CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes - Food & Drug Administration

Flavored Pods Resembling Puff Bar Products Valued at Over $719K

U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized 33,681 units of e-cigarettes with a Manufacturer’s Suggested Retail Price of $719,453.

In December 2020, CBP seized 42 separate shipments arriving from China destined to various Texas counties. The shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow. 

As part of an ongoing joint operation with FDA, officers and agents were looking to intercept counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

“Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers. It is especially alarming when these types of counterfeit and unauthorized products find their way into the hands of children as studies indicate,” said CBP Port Director Timothy Lemaux. “We will continue to take every opportunity to work with our partners at the FDA to intercept and seize products that threaten U.S. consumers.”

Tobacco products including e-cigarettes imported or offered for import into the U.S. must comply with all applicable U.S. laws. 

“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “We are very concerned about how popular these products are with youth. This seizure makes clear to tobacco product manufacturers, retailers and importers that the FDA is keeping a close watch on the marketplace and will hold accountable those companies that violate tobacco laws and regulations.”

CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers. In fiscal year 2020, CBP seized 93,590 units of e-cigarettes that did not meet U.S. federal regulations.

In July 2020, the FDA issued a warning letter to Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These actions are part of the FDA’s ongoing, aggressive effort to take action against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America, including in 2020, refusing admission into the U.S. of at least 150 entries of electronic nicotine delivery systems products for violations of the FD&C Act.     

“Protecting American consumers from illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA,” said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. “We will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.”

While the Puff Bar website appears to have recently stopped online sales and distribution in the U.S, it does not mean that the firm ceased distributing products to other retailers or selling products at brick and mortar retail stores. The website’s store locators are still active, indicating that potential consumers can still search for products located for sale at retail stores.

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.

U.S. Customs and Border Protection (CBP) is the unified border agency within the Department of Homeland Security charged with the management, control, and protection of our Nation's borders at and between the official ports of entry. CBP is charged with keeping terrorists and terrorist weapons out of the country while enforcing hundreds of U.S. laws. CBP’s Office of Field Operations leads the agency’s border security mission at the nation’s 328 ports of entry. CBP officers screen international travelers and cargo searching for illicit narcotics, unreported currency, weapons, counterfeit consumer goods, prohibited agriculture, and other illicit products that could potentially harm the American public, U.S. businesses, and our nation’s safety and economic vitality.


FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs - Food & Drug Administration

Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA1 works to prevent certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs.

Laverdia-CA1 is the first conditionally approved oral treatment for dogs with lymphoma. Because Laverdia-CA1 is orally administered, owners of dogs with a diagnosis of lymphoma, following a veterinarian prescription and safety directions detailed in a client information sheet, can administer this treatment at home. Laverdia-CA1 is given orally twice per week, with at least 72 hours between doses. Laverdia-CA1 is the second treatment for lymphoma in dogs that the FDA has conditionally approved. Tanovea-CA1, which received conditional approval in 2016, is an injectable drug.

“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available. This conditional approval provides a much-needed option to treat dogs with lymphoma,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine.  “We are encouraged to see drug companies bring forward applications for products to treat serious diseases, even if they affect relatively small populations.”

Conditional approval allows veterinarians to access needed treatments while the drug company collects additional effectiveness data, such as through trials with client-owned dogs. The company then has up to five years to complete effectiveness studies to support a full approval.

The reasonable expectation of effectiveness of Laverdia-CA1 was established in a study with 58 client-owned dogs with B- or T-cell lymphoma who were followed for at least eight months. The dogs were either newly diagnosed with lymphoma (naïve) or were in their first relapse after completing a single or multi-agent chemotherapy regimen. The study included dogs of varying breeds, weights and both genders, with the majority of the dogs having lymphoma stage III (generalized lymph node enlargement). Seventeen of the 58 dogs (29%) did not show progression of lymphoma for at least 56 days after taking verdinexor. Three of these dogs did not show any progression for at least 182 days. 

The most common adverse reactions associated with verdinexor were anorexia, vomiting, diarrhea, weight loss, lethargy, increased water intake, increased urination, elevated liver enzymes, and low platelet count. Laverdia-CA1 should be given to dogs immediately after eating, as this increases the amount of drug absorbed into the bloodstream.

The package insert for prescribing veterinarians includes detailed user safety information and special instructions for handling and administering the drug. Gloves tested for use with chemotherapy drugs should always be worn when handling Laverdia-CA1 and cleaning up after a dog undergoing treatment and for three days following the last treatment. This includes handling the dog’s food and water bowls, as well as feces, urine, vomit or saliva from the dog. Laverdia-CA1 also comes with a client information sheet for prescribing veterinarians to give to their clients. This sheet is written specifically for dog owners and explains how to safely handle Laverdia-CA1, how to safely clean up after a dog undergoing treatment and other important safety information.

Pregnant women, women who may become pregnant, and nursing women, should not handle or administer the drug or touch the feces, urine, vomit or saliva of treated dogs. Children also should not touch Laverdia-CA1 or the feces, urine, vomit or saliva of treated dogs. 

Laverdia-CA1 is available only by prescription due to the professional expertise required to diagnose canine lymphoma, provide adequate instructions for post-treatment care, and monitor the safe use of the product, including treatment of any adverse reactions. 

Laverdia-CA1 received conditional approval through the Minor Use/Minor Species pathway, which is an option for drugs intended for minor uses in major species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species. Canine lymphoma affects fewer than 70,000 dogs in the U.S. each year, and therefore, qualifies as a minor use in a major species.

The FDA granted conditional approval of Laverdia-CA1 to Anivive Lifesciences Inc. 

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.

Commerce Department Issues Interim Rule to Secure the ICTS Supply Chain - U.S. Department of Commerce

Pursuant to Executive Order (E.O.) 13873, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain,” today U.S. Department of Commerce Secretary Wilbur Ross issued an interim final rule to address the national security, economic security, and public health and safety concerns related to ICTS Transactions. The rule will ensure the resilience of, and trust in, our Nation’s ICTS supply chain, and, for the purposes of this rule, identifies six foreign governments or foreign non-government persons as foreign adversaries: the People’s Republic of China (China), the Russian Federation (Russia), the Islamic Republic of Iran (Iran), the Democratic People’s Republic of Korea (North Korea), the Republic of Cuba (Cuba), and Venezuelan politician Nicolás Maduro (Maduro Regime).

“Since day one, President Trump has been committed to protecting the national security of all Americans, and the implementation of this rule is a pivotal moment in this Administration’s efforts to put America First and hold bad actors accountable,” said Secretary Ross. “Aggressively securing the ICTS supply chain will protect American citizens and businesses from vulnerabilities that could undermine the confidentiality, integrity, and availability of their personal information or sensitive data by malicious foreign adversaries and those who wish harm on the United States.”

On May 15, 2019, President Trump issued E.O. 13873, which grants the Secretary of Commerce the authority to prohibit certain ICTS Transactions that have been “designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the jurisdiction or direction of foreign adversaries” and that pose an undue or unacceptable risk to the national security of the United States. Today’s rule allows the Department to promulgate regulations to create the processes and procedures that the Secretary of Commerce will use to identify, assess, and address certain transactions.

Today’s rule will be effective 60 days from publication, and Commerce is committed to issuing a subsequent final rule in which the Department will consider and respond to additional comments received.  In addition, the Department will implement procedures for a licensing process 120 days from publication. 

Additional Background:

The E.O. defines “foreign adversary” as “any foreign government or foreign non-government person engaged in a long-term pattern or serious instances of conduct significantly adverse to the national security of the United States or security and safety of United States persons.”


CPSC Issues Consumer Safety Warning: Serious Injury or Death Can Occur if Lithium-Ion Battery Cells Are Separated from Battery Packs and Used to Power Devices - Consumer Product Safety Commission

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) is warning consumers not to buy or use loose 18650 lithium-ion battery cells. These cells are manufactured as industrial component parts of battery packs and are not intended for individual sale to consumers.  However, they are being separated, rewrapped and sold as new consumer batteries, typically on the Internet.

The Dangers of Loose 18650 Battery Cells

Rechargeable lithium cells without proper protection that are not installed in a device or as part of an integral battery (“loose cells”) are potentially hazardous to consumers when handled, transported, stored, charged, or used to power devices.  Specifically, these battery cells may have exposed metal positive and negative terminals that can short-circuit when they come into contact with metal objects, such as keys or loose change in a pocket.  Once shorted, loose cells can overheat and experience thermal runaway, igniting the cell’s internal materials and forcibly expelling burning contents, resulting in fires, explosions, serious injuries and even death.

In addition, thermal runaway can occur in loose cells if consumers use them in inappropriate chargers that allow for charging beyond the cell’s specifications.  Unfortunately, a growing number of small consumer products, such as vaping devices, personal fans, headlamps, and some toys, are using loose 18650s as a power source.  CPSC is working with e-commerce sites, including eBay, to remove listings selling these loose cells. 

Do not use loose 18650 lithium ion cells that are separated from battery packs.  They are often misused as a stand-alone consumer battery, but do not have protection circuits.  For additional information on high-energy battery safety, please visit:
https://www.cpsc.gov/Regulations-Laws--Standards/Voluntary-Standards/Topics/Batteries/

CPSC urges consumers to report problems with lithium-ion batteries to CPSC at: www.SaferProducts.gov.


CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes - Food & Drug Administration

Flavored Pods Resembling Puff Bar Products Valued at Over $719K

U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized 33,681 units of e-cigarettes with a Manufacturer’s Suggested Retail Price of $719,453.

In December 2020, CBP seized 42 separate shipments arriving from China destined to various Texas counties. The shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand, including Puff XXL and Puff Flow. 

As part of an ongoing joint operation with FDA, officers and agents were looking to intercept counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

“Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers. It is especially alarming when these types of counterfeit and unauthorized products find their way into the hands of children as studies indicate,” said CBP Port Director Timothy Lemaux. “We will continue to take every opportunity to work with our partners at the FDA to intercept and seize products that threaten U.S. consumers.”

Tobacco products including e-cigarettes imported or offered for import into the U.S. must comply with all applicable U.S. laws. 

“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “We are very concerned about how popular these products are with youth. This seizure makes clear to tobacco product manufacturers, retailers and importers that the FDA is keeping a close watch on the marketplace and will hold accountable those companies that violate tobacco laws and regulations.”

CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers. In fiscal year 2020, CBP seized 93,590 units of e-cigarettes that did not meet U.S. federal regulations.

In July 2020, the FDA issued a warning letter to Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization. These actions are part of the FDA’s ongoing, aggressive effort to take action against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America, including in 2020, refusing admission into the U.S. of at least 150 entries of electronic nicotine delivery systems products for violations of the FD&C Act.     

“Protecting American consumers from illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA,” said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. “We will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.”

While the Puff Bar website appears to have recently stopped online sales and distribution in the U.S, it does not mean that the firm ceased distributing products to other retailers or selling products at brick and mortar retail stores. The website’s store locators are still active, indicating that potential consumers can still search for products located for sale at retail stores.

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.

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FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs - Food & Drug Administration

Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia-CA1 works to prevent certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs.

Laverdia-CA1 is the first conditionally approved oral treatment for dogs with lymphoma. Because Laverdia-CA1 is orally administered, owners of dogs with a diagnosis of lymphoma, following a veterinarian prescription and safety directions detailed in a client information sheet, can administer this treatment at home. Laverdia-CA1 is given orally twice per week, with at least 72 hours between doses. Laverdia-CA1 is the second treatment for lymphoma in dogs that the FDA has conditionally approved. Tanovea-CA1, which received conditional approval in 2016, is an injectable drug.

“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available. This conditional approval provides a much-needed option to treat dogs with lymphoma,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine.  “We are encouraged to see drug companies bring forward applications for products to treat serious diseases, even if they affect relatively small populations.”

Conditional approval allows veterinarians to access needed treatments while the drug company collects additional effectiveness data, such as through trials with client-owned dogs. The company then has up to five years to complete effectiveness studies to support a full approval.

The reasonable expectation of effectiveness of Laverdia-CA1 was established in a study with 58 client-owned dogs with B- or T-cell lymphoma who were followed for at least eight months. The dogs were either newly diagnosed with lymphoma (naïve) or were in their first relapse after completing a single or multi-agent chemotherapy regimen. The study included dogs of varying breeds, weights and both genders, with the majority of the dogs having lymphoma stage III (generalized lymph node enlargement). Seventeen of the 58 dogs (29%) did not show progression of lymphoma for at least 56 days after taking verdinexor. Three of these dogs did not show any progression for at least 182 days. 

The most common adverse reactions associated with verdinexor were anorexia, vomiting, diarrhea, weight loss, lethargy, increased water intake, increased urination, elevated liver enzymes, and low platelet count. Laverdia-CA1 should be given to dogs immediately after eating, as this increases the amount of drug absorbed into the bloodstream.

The package insert for prescribing veterinarians includes detailed user safety information and special instructions for handling and administering the drug. Gloves tested for use with chemotherapy drugs should always be worn when handling Laverdia-CA1 and cleaning up after a dog undergoing treatment and for three days following the last treatment. This includes handling the dog’s food and water bowls, as well as feces, urine, vomit or saliva from the dog. Laverdia-CA1 also comes with a client information sheet for prescribing veterinarians to give to their clients. This sheet is written specifically for dog owners and explains how to safely handle Laverdia-CA1, how to safely clean up after a dog undergoing treatment and other important safety information.

Pregnant women, women who may become pregnant, and nursing women, should not handle or administer the drug or touch the feces, urine, vomit or saliva of treated dogs. Children also should not touch Laverdia-CA1 or the feces, urine, vomit or saliva of treated dogs. 

Laverdia-CA1 is available only by prescription due to the professional expertise required to diagnose canine lymphoma, provide adequate instructions for post-treatment care, and monitor the safe use of the product, including treatment of any adverse reactions. 

Laverdia-CA1 received conditional approval through the Minor Use/Minor Species pathway, which is an option for drugs intended for minor uses in major species (dogs, cats, horses, cattle, pigs, turkeys and chickens) or for minor species. Canine lymphoma affects fewer than 70,000 dogs in the U.S. each year, and therefore, qualifies as a minor use in a major species.

The FDA granted conditional approval of Laverdia-CA1 to Anivive Lifesciences Inc. 

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.
 
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