Pre-planning and investing in regulatory compliance measures are key to success

The US is the most lucrative wellness market in the world – and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore. 

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute. 

In contrast, China’s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA’s blacklist.

1. Know the regulators

One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says.

Companies also need to designate a US agent to act on their behalf before shipments begin.

“Most entities also don’t realize that the US has 47 regulatory agencies that can regulate imports and exports, so you may be dealing with multiple federal regulatory agencies that regulate your product,” she adds.

For example, the FDA, Federal Trade Commission (FTC) and US Customs regulate the imported supplements market, she says.

2. Beware of being blacklisted

One underestimated risk for SMEs launching their supplements in the US is the FDA’s import alert system, which Diaz describes as a blacklist for companies that have failed to comply with regulations.

This could be anything from mislabeling products to not using English on labels, making false medical claims, or failing to register with the FDA, Diaz explains, adding that it is time-consuming and costly to be removed from the list.

“Many SMEs don’t have the ability to survive the enforcement because the full weight of the government on you when you’re non-compliant is big,” she says.

“The government does not have the resources to hold your hand and help you when it comes to compliance – the expectation is that the product is already compliant and you’re smart enough to pick the right business partners and agents before you launch.”

3. Be wary of influencers

Marketing claims, even those from third parties such as influencers, also fall under FDA and FTC regulations, according to Diaz.

“What many don’t realize is that the FDA can legally make your life miserable over your marketing claims, in addition to what’s on your product,” Diaz says.

For example, suppose a business sends a supplement to an influencer to promote it on social media and they claim that it cured their cancer. In this case, the company is deemed liable if they don’t “de-escalate” the claim, Diaz explains.

“The FDA has the legal ability to issue a company a warning letter for the claims that they make on their website or for the claims that influencers make on their behalf on social media.”

4. Set a budget for compliance

Not spending the time or money on pre-compliance preparation can also lead to costly errors, says Diaz.

“It could be hundreds of thousands of dollars if your goods are seized or you receive an FDA audit or warning letter,” she says.

Diaz recommends that SMEs conduct independent testing in a laboratory to verify ingredient claims, as well as taking out product liability insurance to protect against litigation and organizing a legal review of all labels, ingredients and marketing content.

5. Protect your brand

Diaz also recommends that SMEs protect their brands by registering them with the US Patent and Trademark Office.

“Once you register your trademark, you should also record it with US Customs and then teach them how to spot copies of your brand, such as unique packaging,” Diaz says. 

“Customs then logs it in its secret database and it goes to all customs officers – there are 60,000 customs officers in the country at 328 ports of entry – and they will fine the offender and alert you if they spot a fake.”

• African Growth and Opportunity Act (AGOA) Textile Certificate of Origin
  • The African Growth and Opportunity Act (AGOA) was adopted by the U.S. with the enactment of the Trade and Development Act of 2000 (Pub. L. 106–200). The objectives of AGOA are (1) to provide for extension of duty-free treatment under the Generalized System of Preferences (GSP) to import sensitive articles normally excluded from GSP duty treatment, and (2) to provide for the entry of specific textile and apparel articles free of duty and free of any quantitative limits from eligible countries of sub-Saharan Africa.
  • For preferential treatment of textile and apparel articles under AGOA, the exporter or producer is required to prepare a certificate of origin and provide it to the importer. The certificate of origin includes information such as name and address of the exporter, producer, and importer; the basis for which preferential treatment is claimed; and a description of the imported article(s). The importers are required to have the certificate in their possession at the time of the claim, and to provide it to Customs and Border Protection (CBP) upon request. The collection of this information is provided for in 19 CFR 10.214, 10.215, and 10.216.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 37881) on June 24, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Accreditation of Commercial Testing Laboratories and Approval of Commercial Gaugers
  • Commercial laboratories seeking to become a Customs and Border Protection (CBP) Accredited Laboratory and commercial gaugers seeking to become a CBP Approved Gauger must submit the information specified in 19 CFR 151.12 and 19 CFR 151.13, respectively, to CBP on CBP Form 6478. After the initial accreditation and/or approval, a private company may apply to include additional facilities under its accreditation and/or approval by submitting a formal written request to CBP. This application process is authorized by Section 613 of Public Law 103–182 (North American Free Trade Agreement Implementation Act), codified at 19 U.S.C. 1499(b), which directs CBP to establish a procedure to accredit privately owned testing laboratories. The information collected is used by CBP in deciding whether to approve individuals or businesses desiring to measure bulk products or to analyze importations.
  • U.S. Customs and Border Protection (CBP) invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 39107) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Cargo Container and Road Vehicle Certification for Transport Under Customs Seal
  • The United States is a signatory to several international Customs conventions governing cargo container and road vehicle certification procedures that specify the technical requirements that containers and road vehicles must meet to be acceptable for transport under Customs seal. U.S. Customs and Border Protection (CBP) has the responsibility of administering the procedures within Title 19, Part 115 for the purpose of certifying U.S.-manufactured containers and road vehicles for use in international transport under Customs seal. The certification process involves container and road vehicle manufacturers, owners, or operators submitting applications for approval to the certifying authorities (the entities designated in 19 CFR 115.6: The American Bureau of Shipping; International Cargo Gear Bureau, Inc.; The National Cargo Bureau, Inc.). Applications to request certification approvals from the above-mentioned certifying authorities are submitted directly to these organizations on the appropriate forms (i.e., that are created by the organizations themselves).
  • The certification process is voluntary for manufacturers, and therefore Part 115 does not require certification of said container and road vehicles. A certification of compliance facilitates the efficient movement of containers and road vehicles across international territories. The procedures for obtaining a certification of a container or vehicle are set forth in 19 CFR part 115.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34895) on June 8, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Protest (CBP Form 19)
  • U.S. Customs and Border Protection (CBP) Form 19, Protest, is filed to seek the review of a CBP decision. This review may be conducted by CBP personnel who participated directly in the underlying decision. This form is also used to request ‘‘Further Review,’’ which means a request for review of the protest to be performed by CBP personnel who did not participate directly in the protested decision or by the Commissioner, or his designee, as provided in the CBP regulations. The matters that may be protested include: the appraised value of merchandise; the classification and rate and amount of duties chargeable; all charges within the jurisdiction of the Secretary of Homeland Security or the Secretary of the Treasury; exclusion of merchandise from entry or delivery, or demand for redelivery; the liquidation or reliquidation of an entry or any modification of an entry; the refusal to pay a claim for drawback; refusal to reliquidate an entry made before December 18, 2004 under section 520(c) of the Tariff Act of 1930; or refusal to reliquidate an entry under section 520(d) of the Tariff Act of 1930. The parties who may file a protest or application for further review include: the importer or consignee shown on the entry papers, or their sureties; any person paying any charge or exaction; any person seeking entry or delivery, with respect to a determination of origin under 19 CFR 181 Subpart G any exporter or producer of the merchandise subject to that determination, if the exporter or producer completed and signed a Certification of Origin covering the merchandise as provided for in 19 CR 181.11(a); of any person filing a claim for drawback; or any authorized agent of any of the persons described above.
  • CBP Form 19 collects information such as the name and address of the protesting party, information about the entry being protested, detailed reasons for the protest, and justification for applying for further review.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34894) on June 8, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Administrative Rulings
  • The collection of information in 19 CFR part 177 is necessary in order to enable Customs and Border Protection (CBP) to respond to requests by importers and other interested persons for the issuance of administrative rulings. These rulings pertain to the interpretation of applicable laws related to prospective and current or completed transactions involving, but not limited to classification, marking, valuation, carrier, and country of origin. The collection of information in Part 177 of the CBP Regulations is also necessary to enable CBP to make proper decisions regarding the issuance of binding rulings that modify or revoke prior CBP binding rulings. This collection of information is authorized by 5 U.S.C. 301, 19 U.S.C. 66, 1202, (General Note 3(i), Harmonized Tariff Schedule of the United States), 1502, 1624, 1625. The application to obtain an administrative ruling is accessible at: https://erulings.cbp.gov/s/ or the public can submit a ruling request by mail (or email).
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 35563) on June 10, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Ajmal Steel Tubes & Pipes Industries v. United States
  • This action is a challenge to the final determination made by the United States Department of Commerce (“Commerce”) in the periodic review of the antidumping (“AD”) order for carbon-quality pipe from the United Arab Emirates (“UAE”) covering the period from December 1, 2018, through November 30, 2019.
  • Plaintiff requests that the court hold aspects of Commerce’s final determination unsupported by substantial evidence or otherwise not in accordance with law. The United States (“Government”) asks that the court sustain Commerce’s final determination.
  • Ajmal Steel Tubes & Pipes Ind. LLC (“Ajmal”) is a producer of carbon-quality pipe from the UAE. Since 2016, this product has been subject to an AD order. On March 3, 2020, Commerce selected Ajmal and Universal Tube and Plastic Industries, Ltd. (“Universal”) as mandatory respondents for an administrative review of the anti-dumping order and issued questionnaires with the Section A responses due March 24, 2020. Subsequently, Ajmal submitted an extension of time request (“EOT”) on March 19, 2020, and another EOT on April 3, 2020, for delays “due to the COVID-19 global pandemic.”
  • The Court held that Commerce abused its discretion in denying Ajmal’s First Request for Reconsideration. The Court remanded to Commerce to accept and consider Ajaml’s Section A filing and complete the review.

• Proposed Revocation of Three Ruling Letters and Proposed Revocation of Treatment Relating to the Tariff Classification of Wireless Headphone Sets from China and an Undisclosed Country
  • In NY N022195, NY N022204 and NY N240329, CBP classified wireless headphone sets in heading 8517, HTSUS, specifically in subheading 8517.62.00, HTSUS, which provides for “Other apparatus for transmission or reception of voice, images or other data, including apparatus for communication in a wired or wireless network (such as a local or wide area network): Machines for the reception, conversion and transmission or regeneration of voice, images or other data, including switching and routing apparatus.” CBP has reviewed NY N022195, NY N022204 and NY N240329, and has determined the ruling letters to be in error.
  • It is now CBP’s position that the wireless headphone sets are properly classified in heading 8518, HTSUS, specifically in subheading 8518.30.20, HTSUS, which provides for “Microphones and stands therefor; loudspeakers, whether or not mounted in their enclosures; headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers; audio-frequency electric amplifiers; electric sound amplifier sets; parts thereof: Headphones and earphones, whether or not combined with a microphone, and sets consisting of a microphone and one or more loudspeakers: Other.”
• Country of Origin Marking Requirements for Containers or Holders
  • Section 304 of the Tariff Act of 1930, as amended, 19 U.S.C. 1304, requires each imported article of foreign origin, or its container, to be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article or container permits, with the English name of the country of origin. The marking informs the ultimate purchaser in the United States of the country of origin of the article or its container. The marking requirements for containers or holders of imported merchandise are provided for by 19 CFR 134.22(b).
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (Volume 87 FR Page 39108) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Delivery Ticket
  • CBP Form 6043, Delivery Ticket, is used to document transfers of imported merchandise between parties. This form collects information such as the name and address of the consignee; the name of the importing carrier; lien information; the location of where the goods originated and where they were delivered; and information about the imported merchandise. CBP Form 6043 is completed by warehouse proprietors, carriers, Foreign Trade Zone operators and other trade entities involved in transfers of imported merchandise.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 36867) on June 21, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Customs and Border Protection Recordkeeping Requirements
  • The North American Free Trade Agreement Implementation Act, Title VI, known as the Customs Modernization Act (Mod Act) amended Title 19 U.S.C. 1508, 1509 and 1510 by revising Customs and Border Protection (CBP) laws related to recordkeeping, examination of books and witnesses, regulatory audit procedures and judicial enforcement. Specifically, the Mod Act expanded the list of parties subject to CBP recordkeeping requirements; distinguished between records which pertain to the entry of merchandise and financial records needed to substantiate the correctness of information contained in entry documentation; and identified a list of records which must be maintained and produced upon request by CBP.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 35565) on June 10, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Application-Permit-Special License Unlading-Lading-Overtime Services
  • The Application-Permit-Special License Unlading-Lading-Overtime Services (U.S. Customs and Border Protection (CBP) Form 3171) is used by commercial carriers and importers as a request for permission to unlade imported merchandise, baggage, or passengers. It is also used to request overtime services from CBP officers in connection with lading or unlading of merchandise, or the entry or clearance of a vessel, including the boarding of a vessel for preliminary supplies, ship’s stores, sea stores, or equipment not to be re-laden.
  • This form is anticipated to be submitted electronically as part of the maritime forms automation project through the Vessel Entrance and Clearance System (VECS), which will eliminate the need for any paper submission of any vessel entrance or clearance requirements under the above referenced statutes and regulations. VECS will still collect and maintain the same data but will automate the capture of data to reduce or eliminate redundancy with other data collected by CBP.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 31252) on May 23, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Holders or Containers Which Enter the United States Duty Free
  • Subheading 9803.00.50 of the Harmonized Tariff Schedule of the United States (HTSUS), codified as 19 U.S.C. 1202, provide for the release without entry or the payment of duty of certain substantial holders or containers pursuant to the provisions of 19 CFR 10.41b. Section 19 CFR 10.41b eliminates the need for an importer to file entry documents by instead requiring, among other things, the marking of the containers or holders to indicate the HTSUS numbers that provide for duty-free treatment of the containers or holders.
  • For U.S. manufactured serially numbered holders or containers which may be released without entry or the payment of duty under 9801.00.10 HTSUS, 19 CFR 10.41b requires the owner to place the following markings on the holder or container: 9801.00.10, HTSUS (unless the holder or container has a permanently attached metal tag or plate showing, among other things, the name and address of the U.S. manufacturer); the name of the owner; and the serial number assigned by the owner.
  • For serially numbered holders or containers of foreign manufacture for which may be released without entry or payment of duty under 9803.00.50 HTSUS, 19 CFR 10.41b requires the owner to place markings containing the following information: 9803.00.50 HTSUS; the district and port code numbers of the port of entry; the entry number; the last two digits of the fiscal year of entry covering the importation of the holders and containers on which duty was paid; the name of the owner; and the serial number assigned by the owner.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34283) on June 6, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Declaration for Free Entry of Unaccompanied Articles (CBP Form 3299)
  • 19 U.S.C. 1498 provides that when personal and household effects enter the United States but do not accompany the owner or importer on his/her arrival in the country, a declaration is made on CBP Form 3299, Declaration for Free Entry of Unaccompanied Articles. The information on this form is needed to support a claim for duty-free entry for these effects.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 37882) on June 24, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• User Fees (CBP Form 339A, 339C, and 339V)
  • The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) (Pub. L. 99–272, 100 Stat. 82; 19 U.S.C. 58c), as amended, authorizes the collection of user fees by U.S. Customs and Border Protection (CBP). The collection of these fees requires submission of information from the party remitting the fees to CBP. This collection of information is provided for by 19 CFR 24.22. In certain cases, this information is submitted on one of three forms including the CBP Form 339A for payment upon arrival or prepayment of the annual user fee for a private aircraft (19 CFR 24.22(e)(1) and (2)), CBP Form 339C for prepayment of the annual user fee for a commercial vehicle (19 CFR 24.22(c)(3)), and CBP Form 339V for payment upon arrival or prepayment of the annual user fee for a private vessel (19 CFR 24.22(e)(1) and (2)).
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 39105) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Exportation of Used Self-Propelled Vehicles
  • U.S. Customs and Border Protection (CBP) regulations require a person attempting to export a used self-propelled vehicle to furnish documentation to CBP at the port of export. Exportation of a vehicle is permitted only upon compliance with these requirements. The required documentation includes, but is not limited to, a Certificate of Title or a Salvage Title, the Vehicle Identification Number (VIN), a Manufacturer’s Statement of Origin, etc. CBP will accept originals or certified copies of the Certificate of Title. The purpose of this information is to help ensure that stolen vehicles or vehicles associated with other criminal activity are not exported.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 39107) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Canadian Border Boat Landing Permit (CBP Form I-68)
  • The Canadian Border Boat Landing Permit, U.S. Customs and Border Protection (CBP) Form I–68, generally allows select individuals entering the United States along the northern border by small1 pleasure boats to report their arrival and make entry without having to travel to a designated port of entry for an inspection by a CBP officer. The information collected on CBP Form I–68 allows eligible individuals to be inspected in person only once during the boating season, rather than each time they make an entry. United States citizens, Lawful Permanent Residents of the United States, Canadian citizens, and Landed Residents of Canada who are nationals of the Visa Waiver Program countries listed in 8 CFR 217.2(a) are eligible to apply for the permit.
  • CBP has developed a smart phone application known as ROAM that will in certain circumstances allow travelers participating in the I–68 program to report their arrival in the United States through the ROAM application, instead of by telephone. The ROAM app, implementing the I–68 program, will allow CBP officers to remotely conduct traveler interviews with a phone’s video chat capability, and replace other technologies used for remote inspections that are obsolete or inefficient.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34282) on June 6, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Application to Establish a Centralized Examination Station
  • A Centralized Examination Station (CES) is a privately operated facility where merchandise is made available to CBP officers for physical examination. If a port director decides that a CES is needed, he or she solicits applications to operate a CES. The information contained in the application is used to determine the suitability of the applicant’s facility; the fairness of fee structure; and the knowledge of cargo handling operations and of CBP procedures and regulations. The names of all principals or corporate officers and all employees who will come in contact with uncleared cargo are also to be provided so that CBP may perform background investigations. The CES application is provided for by 19 CFR 118.11 and is authorized by 19 U.S.C. 1499, Tariff Act of 1930.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 36867) on June 21, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
  • The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Oman Fasteners, LLC v. United States
  • Plaintiff Oman Fasteners, LLC seeks relief from defendants’ refusal to allow bonding in lieu of cash deposits for potential liability for duties under a Presidential Proclamation, Proclamation No. 9980, Adjusting Imports of Derivative Aluminum Articles and Derivative Steel Articles Into the United States, 85 Fed. Reg. 5,281 (Exec. Office of the President Jan. 29, 2020) (“Proclamation 9980”), which imposed duties on various imported products made of aluminum or steel, including steel fasteners.
  • Granting Oman Fasteners’ motion in part and denying it in part, we require defendants to exclude Oman Fasteners from a requirement to post cash deposits for potential duty liability under Proclamation 9980 until such time as defendants obtain a further order from this Court or Oman Fasteners voluntarily enters into an agreement with defendants that modifies the terms of this Opinion and Order.
• Garg Tube Export v. United States
  • Before the court is the U.S. Department of Commerce’s second redetermination on remand filed pursuant to the court’s order in Garg Tube Exp, LLP v. United States, 569 F. Supp. 3d 1202 (Ct. Int’l Trade 2022) (“Garg II”) in connection with Commerce’s 2017–2018 administrative review of the antidumping duty (“ADD”) order on welded carbon steel standard pipes and tubes (“CWP”) from India, covering the period of review from May 1, 2017 to April 30, 2018.
  • In Garg II, the court remanded Commerce’s first remand results to reconsider its determination that a particular market situation (“PMS”) existed in India for hot-rolled coil steel (“HRC”) and its regression methodology applying a PMS adjustment or explain its determinations and support them with substantial evidence. Garg II, 569 F. Supp. 3d at 1220–21. On remand, under respectful protest, Commerce no longer finds that a PMS existed, and accordingly no longer applies a PMS adjustment to the costs of production for sales based on constructed value. Pursuant to Ct. Remand, June 9, 2022, ECF No. 98 at 17–22 (“Second Remand Results”). Commerce’s redetermination is supported by substantial evidence and complies with the court’s remand instructions. Therefore, Commerce’s Second Remand Results are sustained.

• Period of Admission and Extensions of Stay for Representatives of Foreign Information Media Seeking to Enter the United States
  • This rule amends Department of Homeland Security (DHS) regulations to better facilitate the U.S. Government’s ability to achieve greater reciprocity between the United States and the People’s Republic of China (PRC) relative to the treatment of representatives of foreign information media of the respective countries seeking entry into the other country.
  • For entry into the United States, such foreign nationals would seek to be admitted in I nonimmigrant status as bona fide representatives of foreign information media. Currently, foreign nationals who present a passport issued by the PRC, with the exception of Hong Kong Special Administrative Region (SAR) or Macau SAR passport holders, may be admitted in or otherwise granted I nonimmigrant status until the activities or assignments consistent with the I classification are completed, not to exceed 90 days.
  • This rule amends the DHS regulations to remove the set period of stay of up to 90 days and to allow the Secretary of Homeland Security (Secretary) to determine the maximum period of stay, no longer than one year, for PRC I visa holders, taking into account certain factors.
  • This rule also announces the Secretary has determined the maximum period of stay for which a noncitizen who presents a passport issued by the PRC (other than a Hong Kong SAR passport or a Macau SAR passport) may be admitted in or otherwise granted I nonimmigrant status is one year
  • This rule was effective on October 13, 2022.
• Arrival Restrictions Applicable to Flights Carrying Persons Who Have Recently Traveled From or Were Otherwise Present Within Uganda
  • This document announces the decision of the Secretary of the Department of Homeland Security (DHS) to direct all flights to the United States carrying persons who have recently traveled from, or were otherwise present within, Uganda to arrive at one of the United States airports where the United States government is focusing public health resources to implement enhanced public health measures.
  • For purposes of this document, a person has recently traveled from Uganda if that person departed from, or was otherwise present within, Uganda within 21 days of the date of the person’s entry or attempted entry into the United States.
  • Also, for purposes of this document, crew and flights carrying only cargo (i.e., no passengers or non-crew), are excluded from the measures herein.
  • The arrival restrictions apply to flights departing after 11:59 p.m. Eastern Daylight Time on October 10, 2022. Arrival restrictions continue until cancelled or modified by the Secretary of DHS and notice of such cancellation or modification is published in the Federal Register.
• Proposes Revocation of Two Ruling Letters and Proposed Revocation of Treatment Relating to the Tariff Classification of Pan Masala Betel Nut Food Product
  • In NY 830068 and DD H890859, CBP classified the pan masala betel nut food product in heading 2106, HTSUS, specifically in subheading 2106.90.6099, HTSUS Annotated (HTSUSA) (currently subheading 2106.90.99, HTSUS, under the 2022 HTSUS), which provides for “Food preparations not elsewhere specified or include Other: Other: Other: Other.”
  • CBP has reviewed both NY 830068 and DD H890859 and has determined the ruling letters to be in error.
  • It is now CBP’s position that pan masala betel nut food product is properly classified, in heading 2008, HTSUS, specifically in subheading 2008.19.9090, HTSUSA, which provides for “Fruit, nuts and other edible parts of plants, otherwise prepared or preserved, whether or not containing added sugar or other sweetening matter or spirit, not elsewhere specified or included: Other, including mixtures: Other, including mixtures: Other: Other.”
• Nucor Corporation v. United States
  • Plaintiff Nucor Corporation (“Nucor”) challenges the U.S. Department of Commerce’s (“Commerce” or “the agency”) final results in the 2018 administrative review of the countervailing duty (“CVD”) order on certain carbon and alloy steel cut-to-length plate (“CTL plate”) from the Republic of Korea (“Korea”).
  • Nucor challenges Commerce’s determination not to initiate an investigation into the alleged provision of off-peak electricity for less than adequate remuneration (sometimes referred to as “LTAR”) and Commerce’s determination that mandatory respondent POSCO and its affiliate POSCO Plantec (“Plantec”) do not meet the requirements necessary to find a cross-owned input supplier relationship.
  • The Court ordered the following:
    • 1. That Commerce’s Final Results are sustained in part and remanded in part.
    • 2. On remand, Commerce shall reconsider or further explain its determination not to investigate the alleged off-peak sale of electricity for less than adequate remuneration.
    • 3. On remand, Commerce shall reconsider or further explain its determination not to treat Plantec as a cross-owned input supplier in connection with the supply of scrap.
    • 4. Commerce shall file its remand redetermination on or before January 3, 2023.
    • 5. Subsequent proceedings shall be governed by US-CIT Rule 56.2(h); if, however Commerce determines to investigate whether off-peak electricity is provided for less than adequate remuneration, the Parties may instead file a joint status report addressing the timing of any necessary further administrative proceedings.
    • 6. Any comments or responsive comments must not exceed 4,000 words.

Customs and Border Protection (CBP)

• U.S. Customs and Border Protection (CBP) on October 18,2022, published two Final Rules that update provisions in 19 CFR 111: Modernization of the Customs Broker Regulations (87 FR 63267) and Elimination of Customs Broker District Permit Fee (87 FR 63262). 
• CBP is transitioning all customs brokers to a single national permit and expanding the scope of the national permit authority to allow national permit holders to conduct any type of customs business throughout the customs territory of the United States. 
• CBP provides this message to provide guidance regarding the amendment of a previously granted Section 301 China product exclusion to conform with the U.S. International Trade Commission’s (USITC) Harmonized Tariff Schedule (HTS) changes effective July 1, 2021. 
• CBP on October 18, 2022, published two Final Rules that updated provisions in 19 CFR 111: Modernization of the Customs Broker Regulations (87 FR 63267) and Elimination of Customs Broker District Permit Fee (87 FR 63262). 
• CBP is hosting two webinars to discuss changes to 19 CFR 111. The first webinar “Customs Broker Modernization Regulations – Detailed changes to 19 CFR 111,” is scheduled for Thursday, October 27, 2022, from 1-2 p.m., Eastern Daylight Time. 
• CBP announced the revocation of three ruling letters, modification of one ruling letter, and revocation of treatment relating to the tariff classification of certain step stools.  
• CBP announced the proposed modification of one ruling letter and proposed revocation of treatment relating to the tariff classification of paper face masks.  
• CBP announced a proposed change to CBP form 1303, used for declaring articles to be retained on board the vessel, such as sea stores, ship’s stores (e.g., alcohol and tobacco products), controlled narcotic drugs or bunker fuel in a format that can be readily audited and checked by CBP.
• CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 
• CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 
• CBP announced the following copyrights, trademarks, and trade names recorded with CBP.  

United States Department of Treasury (USDT)

• Department of the Treasury (USDT), as Chair of the Committee on Foreign Investment in the United States (“CFIUS” or the “Committee”), released on October 20, 2022, the first-ever CFIUS Enforcement and Penalty Guidelines.   

United States Department of Commerce (DOC)

• DOC preliminarily determines that six exporters of certain hardwood plywood products (hardwood plywood) from the People’s Republic of China (China) under review had no shipments of subject merchandise during the period of review (POR) January 1, 2021, through December 31, 2021. 
• DOC has issued an order temporarily denying export privileges for URAL Airlines for a period of 180 days.  
• DOC announced on October 20, 2022, a renewal of temporary denial of export privilege for Aviastar in the in the public interest to prevent an imminent violation of the regulations.  

U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC)

• OFAC and OFSI on October 13, 2022, concluded a multi-day technical exchange in London that will bring significant benefits to both organizations and reinforce coordination and collaboration between the U.S. and UK in the years to come. 
• OFAC announced on October 18, 2022, the issuance of a finding of Violation to Nodus International Bank, Inc. (Nodus), an international financial entity located in Puerto Rico, for violations of the Venezuelan Sanctions Regulations (VSR), and the Reporting, Penalties and Procedures Regulations (RPPR). 
• OFAC on October 19, 2022, designated Juan Francisco Valenzuela Valenzuela and the Valenzuela Drug Trafficking Organization (“Valenzuela DTO”), among others, pursuant to Executive Order (E.O.) 14059.     
• OFAC, in coordination with the U.S. Department of Justice and the Federal Bureau of Investigation (FBI), on October 19, 2022, designated a Russian network that procured military and sensitive dual-use technologies from U.S. manufacturers and supplied them to Russian end-users.
• OFAC, in conjunction with BIS, and the Department of State have imposed an unprecedented range of sanctions and export controls in response to Russia’s attack on Ukraine.   

United States International Trade Commission (USITC)

• U.S. International Trade Commission (USITC) has received a complaint entitled Certain Electronic Devices, Semiconductor Devices, and Components Thereof, DN 3647; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant’s filing pursuant to the Commission’s Rules of Practice and Procedure. 
• USITC has found no violation of section 337 of the Tariff Act of 1930, as amended, in the investigation into certain artificial eyelash extension systems, products, and components thereof. The investigation is terminated. 
• USITC has determined not to review two initial determinations (‘‘IDs’’) of the presiding administrative law judge (‘‘ALJ’’): (1) Order No. 23 terminating the investigation as to claims 17–21 of U.S. Patent No. 8,468,547 (‘‘the ’547 patent’’) (collectively, the ‘‘Withdrawn Claims’’); and (2) Order No. 24 granting complainants’ motion to amend the complaint and notice of investigation (‘‘NOI’’) in the graphics systems investigation to correct the names of two respondents. 
• USITC hereby give notices that on October 7, 2022, the presiding administrative law judge (‘‘ALJ’’) issued an Initial Determination on Violation of Section 337. The ALJ also issued a Recommended Determination on remedy and bonding should a violation be found in the Robotic Floor Cleaning Devices investigation. 
• USITC hereby gives notice that a complaint was filed on August 23, 2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of Daedalus Prime LLC of Bronxville, New York. A supplement to the complaint was filed on September 12, 2022. 
• USITC has implemented certain changes to the Harmonized Tariff Schedule of the United States (HTSUS) to reflect Harmonized System modifications adopted by the World Customs Organization and changes to statistical categories. 
• USITC announces conforming amendments to legal note provisions in the HTSUS associated with the actions in the section 301 investigation of China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation. 
• USITC announces the cancellation of hearings for full five-year reviews in the Circular Welded Carbon-Quality Steel Pipe from Oman, Pakistan, and the United Arab Emirates investigation.
• USITC hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701–TA–683 and 731–TA–1594–1596 (Preliminary) pursuant to the Tariff Act of 1930 (‘‘the Act’’) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of paper file folders from China, India, and Vietnam, provided for in subheading 4820.30.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of India.  
• USITC received a complaint on September 13, 2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of Daedalus Prime LLC of Bronxville, New York. 
• USITC received a complaint on September 13,2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of Vego Garden, Inc. of Houston, Texas. 
• USITC received a complaint on September 13,2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of Daedalus Prime LLC of Bronxville, New York. 
• USITC is holding Sunshine Act Meeting on October 26, 2022, in Washington, D.C.  
• USITC hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (‘‘the Act’’) to determine whether revocation of the countervailing duty order on finished carbon steel flanges from India and the antidumping duty orders on finished carbon steel flanges from India, Italy, and Spain would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. 
• USITC has received a complaint entitled Certain Semiconductors Devices Having Layered Dummy Fill, Electronic Devices, and Components Thereof, DN 3649; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant’s filing pursuant to the Commission’s Rules of Practice and Procedure. 

United States Department of Labor (DOL)

• Department of Labor (DOL) announced pursuant to the Federal Advisory Committee Act (FACA), as amended, and the Workforce Innovation and Opportunity Act (WIOA), notice is hereby given of the next meeting of the Native American Employment and Training Council (Council), as constituted under WIOA. 

United States Department of Justice (DOJ)

• United States Department of Justice (DOJ), on behalf of the FDA, on October 18, 2022, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. 

The White House and Congress

• President Biden on October 7, 2022, signed executive order 14086 “Enhancing Safeguards for United States signals Intelligence Activities.”

RKW Klerks V. United States

• RKW Klerks V. United States: In a case that involved the classification of two types of net wrap, both of which were synthetic fabrics used to wrap round bales of harvested crops, the U.S. Customs and Border Protection properly classified the net wraps under HRSUS subheading 6005.39.00.  

Defense Trade Advisory Group (DTAG) 

• Defense Trade Advisory Group (DTAG) will meet in open session from 1:00 p.m. until 5:00 p.m. on Wednesday, November 9, 2022. The purpose of the meeting will be to discuss current defense trade issues and topics for further study. 

U.S. Department of the Treasury (USDT) 

• U.S. Department of the Treasury (USDT) on October 17, 2022, designated a network of al-Shabaab financial facilitators who hold leadership roles within al-Shabaab and act as key interlocutors between the group and local companies in Somalia.  

United States Trade Representative (USTR)

• United States Trade Representative (USTR) announced with this notice its determination to make two technical amendments to certain previously reinstated exclusions associated with the section 301 investigation of China Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation. 

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

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Customs and Border Protection (CBP)

• On September 7, 2022, U.S. Customs and Border Protection (CBP) modified the Withhold Release Order (WRO) against Natchi Apparel (P) Ltd. garment imports, which was originally issued due to concerns about forced labor compliance. Effective immediately, Natchi Apparel (P) Ltd. shipments will be allowed to enter U.S. commerce. Shipments that have previously been detained will also be released.
• CBP released a Cargo Systems Messaging Service stating that on September 13, 2022, there will be a Quota Opening on QB 23-502 2023 Tobacco with a commodity on Tobacco, Chapter 24, Additional U.S. Note 5 through September 12, 2023.
• On September 8, 2022, CBP issued a final determination concerning the country of origin of certain SCORE®7T tablets. Based upon the facts presented, CBP has concluded that the country of origin of the SCORE®7T tablets in question is Taiwan for purposes of U.S. Government procurement.

Office of the United States Trade Representative (USTR)

• On August 31, 2022, according to the Office of the United States Trade Representative (USTR), the parties to the United States-Mexico-Canada Agreement (USMCA) intend to hold the second meeting of the Environment Committee (Committee) on September 23, 2022. Following the government-to- government Committee meeting, the Committee will hold a virtual public session. The USTR will accept comments on suggestions for topics to be discussed during the Committee meeting, and questions for the public session.
• On September 2, 2022, the USTR issues a press release confirming that the 301 tariffs on Lists 1 and 2 would continue. This occurred after representatives of the domestic industries benefiting from the tariff actions requested continuation of the tariffs. The same can be expected when it comes t o Lists 3 and 4A, but their review period has not yet ripened.
• In accordance with the U.S.-Australia Free Trade Agreement entered into by the United States and the Commonwealth of Australia and the Harmonized Tariff Schedule of the United States (HTSUS), USTR provided a notice of tariff-rate quota quantity limitations of certain tariff subheadings.
• In a notice published on May 5, 2022, USTR announced the first step in the statutory four-year review process of the two actions, as modified, taken under Section 301 in the investigation of China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation.

United States Department of the Treasury’s Office of Foreign Assets Control (OFAC)

• The Office of Foreign Assets Control (OFAC) is amending, and reissuing in their entirety, the Cyber-Related Sanctions Regulations, 31 C.F.R. part 578. This administrative action replaces the regulations that were published in abbreviated form on December 31, 2015, with a more comprehensive set of regulations that includes additional interpretive and definitional guidance, general licenses, and other regulatory provisions that will provide further guidance to the public.
• On September 2, 2022, according to OFAC, G7 Finance Ministers issued a statement confirming their joint intention to implement a price cap with respect to Russian-origin crude oil and petroleum products.
• OFAC is publishing two general licenses (GLs) issued in the Russian Harmful Foreign Activities Sanctions Regulations: GLs 38A and 50, each of which was previously made available on OFAC’s website.
• OFAC is publishing five general licenses (GLs) issued pursuant to the Russian Harmful Foreign Activities Sanctions Regulations: GLs 40A, 43A, 47, 48, and 49, each of which was previously made available on OFAC’s website.
• OFAC is publishing three general licenses (GLs) issued in the Russian Harmful Foreign Activities Sanctions Regulations: GLs 40B, 47A, and 48A, each of which was previously made available on OFAC’s website.
• OFAC is publishing four general licenses (GLs) issued in the Russian Harmful Foreign Activities Sanctions program: GLs 8, 8A, and 8B, which were previously issued on OFAC’s website and are now expired, and GL 8C, which was also issued on OFAC’s website and expires December 5, 2022.

United States Department of Commerce (DOC)

• The U.S. Department of Commerce (DOC) preliminarily determines that vertical shaft engines with displacements between 60cc and up to 99cc produced in the People’s Republic of China (China) and exported to the United States, are circumventing the antidumping duty (AD) and countervailing duty (CVD) orders on certain vertical shaft engines between 99cc and up to 225cc, and parts thereof (small vertical engines), from China.
• In accordance with the Federal Advisory Committee Act (FACA), DOC, this notice announces, the United States Investment Advisory Council (IAC) will hold a public meeting on September 29, 2022.
• DOC’s Bureau of Economic Analysis (BEA) has made a final ruling amending regulations requiring a renewal of reporting for the BE-120 Benchmark Survey of Transactions in the Selected Services and Intellectual Property with Foreign Persons.
• DOC has completed its administrative review of the antidumping duty order on certain cased pencils (cased pencils) from the People’s Republic of China (China) for the period of review (POR) December 1, 2020, through November 30, 2021.
• DOC preliminarily determines that countervailable subsidies are being provided to producers/exporters of certain passenger vehicle and light truck tires (passenger tires) from the People’s Republic of China (China) during the period of review (POR), January 1, 2020, through December 31, 2020.
• DOC preliminarily finds that certain producers and exporters of passenger vehicle and light truck tires (passenger tires) from the People’s Republic of China (China) made sales of subject merchandise at prices below normal value (NV) during the period of review (POR), August 1, 2020, through July 31, 2021.
• DOC determines that certain companies under review sold common alloy aluminum sheet (aluminum sheet) from the People’s Republic of China (China) at less than normal value during the period of review (POR) February 1, 2020, through January 31, 2021.
• DOC preliminarily finds that producers and/or exporters subject to this administrative review made sales of subject merchandise at less than normal value (NV) during the period of review (POR) August 1, 2020, through July 31, 2021.
• DOC preliminarily determines that Norma (India) Ltd. (Norma) and R.N. Gupta & Co. Ltd. (RNG) received countervailable subsidies during the period of review (POR), January 1, 2020, through December 31, 2020.
• DOC preliminarily determines that Maquilacero S.A. de C.V. (Maquilacero) and Tecnicas de Fluidos S.A. de C.V. (TEFLU), (collectively, Maquilacero/TEFLU) and Regiomontana de Perfiles y Tubos S. de R.L. de C.V. (Regiopytsa) made sales of light-walled rectangular pipe and tube from Mexico at less than normal value during the period of review August 1, 2020, through July 31, 2021.
• DOC determines that exporters/producers of stainless steel bar (SS Bar) from India made sales at prices below normal value during the period of review (POR) of February 1, 2020, through January 31, 2021.
• Pursuant to provisions of the Federal Advisory Committee Act, the DOC announces the renewal of the Civil Nuclear Trade Advisory Committee (CINTAC or “Committee”) and requests nominations for membership.
• On August 22, 2022, the DOC published notice in the Federal Register of a negative final determination of subsidies in connection with the subject investigation concerning Thailand (87 FR 51343).

United States International Trade Commission (USITC)

• The United States International Trade Commission (USITC) hereby gives notice of the scheduling of the final phase of countervailing and antidumping duty investigation Nos. 701-TA-678 and 731-TA-1584 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of barium chloride from India, provided for in subheading 2827.39.45 of the Harmonized Tariff Schedule of the United States.
• On the basis of the record ^[1] developed in the subject five-year review, the USITC determines, pursuant to the Tariff Act of 1930 (“the Act”), that revocation of the antidumping duty order on wooden bedroom furniture from China would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.

Bureau of Industry and Security (BIS)

• On November 17, 2020, according to the Bureau of Industry and Security (BIS), in the U.S. District Court for the District of Arizona, Wei Sun (“Sun”) was convicted of knowingly and willfully exporting from the United States to China, technical data, specifically, two files of computer data contained in an HP Elitebook 840 computer possessed by Sun, controlled under the International Traffic in Arms Regulations and the United State Munitions List without having first obtained from the Department of State a license for such export or written authorization for such export.

White House

• According to the Biden administration, the United States tech companies that receive federal funding will be barred from building “advanced technology” facilities in China for 10 years, the Biden administration has said.
• According to a statement from White House, while America invented the semiconductor, we currently only produce about 10 percent of the world’s supply. All of this has led to the passage of the CHIPS and Science Act of 2022, designed to tackle the chip shortage with a new approach to bringing chip technology, manufacturing, and innovation to the United States.

United States Court of International Trade (CIT)

• On August 25, 2022, the U.S. Court of International Trade (CIT) issued its final judgment in Saha Steel Pipe Public Company, Ltd v. United States, Court No. 20-00133, Slip Op. 22-99 ( Saha Steel), sustaining the Department of Commerce (DOC)’s final results of redetermination pertaining to the scope ruling for the antidumping duty (AD) order on circular welded carbon steel pipes and tubes (CWP) from Thailand.

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

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Sanctions on DNR and LNR regions of Ukraine 

On February 21, 2022, the Office of Foreign Assets Control (OFAC) issued an executive order (E.O.) blocking property of certain persons and prohibiting certain transactions with respect to continued Russian efforts to undermine the sovereignty and territorial integrity of Ukraine in addition to an issuance of Ukraine related general licenses. More specifically, this E.O. prevents any U.S. persons from engaging the Donetsk People’s Republic (DNR) or Luhansk People’s Republic (LNR) (collectively named the “Covered Regions”) in most, if not all activities, including the following:

• new investment in the Covered Regions
• the importation into the United States, directly or indirectly, of any goods, services, or technology from the Covered Regions
• the exportation, re-exportation, sale, or supply, from the United States or by a U.S. person, directly or indirectly, of any goods, services, or technology to the Covered Regions
• any approval, financing, facilitation, or guarantee by a foreign person that would also be prohibited for a U.S. person. 

This E.O. also gives OFAC the authority to impose further sanctions on persons and entities determined to be:

• operating in the Covered Regions
• a leader, official, senior executive officer, or member of the board of directors of an entity operating in the Covered Regions
• owned or controlled by any person whose property and interests in property are blocked pursuant to this order
• materially assisting, sponsoring, or providing financial, material, or technological support for, or goods or services to or in support of, any person and property blocked under this E.O. 

Sanctions on Russia 

On February 24, 2022, the United States took significant and unprecedented action to respond to Russia’s further invasion of Ukraine by imposing severe economic costs that will have both immediate and long-term effects on the Russian economy and financial system.

Targeting Russia’s Two Largest Financial Institutions

• The U.S. Treasury is taking “unprecedented action” against Russia’s two largest financial institutions, Public Joint Stock Company Sberbank of Russia (Sberbank)and VTB Bank Public Joint Stock Company (VTB Bank), drastically disrupting their ability to operate in U.S. dollars and process payments through the U.S. financial system.

Correspondent and Payable-Through Account Sanctions on Sberbank

• As part of the sanctions on Sberbank, the Treasury is requiring all U.S. financial institutions to close any Sberbank correspondent or payable-through accounts and to reject any future transactions involving Sberbank or its foreign financial institution subsidiaries within 30 days.
  • To implement these sanctions on Sberbank, OFAC issued Directive 2 under E.O. 14024, prohibiting U.S. financial institutions from:
    • the opening or maintaining of a correspondent account or payable-through account for or on behalf of any entity determined to be subject to the prohibitions of the Russia-related CAPTA Directive, or their property or interests in property
    • the processing of transactions involving any such entities determined to be subject to the Russia-related CAPTA Directive, or their property or interests in property. 
• Sberbank and other affiliated entities determined to be subject to the Russia-related CAPTA Directive have been added to OFAC’s CAPTA List.
  • The prohibitions of the Russia-related CAPTA Directive take effect beginning on March 26, 2022. Accordingly, by March 26, 2022, U.S. financial institutions must have closed any correspondent or payable-through account maintained for Sberbank all other entities listed in Annex 1 to the Russia-related CAPTA Directive, and all foreign financial institutions owned 50 percent or more by the foregoing. 

Full Blocking Sanctions on VTB

• OFAC has imposed full blocking sanctions on VTB Bank and 20 of its subsidiaries, for being owned, controlled by, or acting on behalf of (either directly or indirectly) the Government of Russia the GoR, and having operated in the financial services sector of the Russian Federation economy. Further, all entities owned 50 percent or more, directly or indirectly, by VTB Bank are subject to blocking, even if not identified by OFAC.

Blocking Other Major Russian Financial Institutions 

OFAC has also imposed blocking sanctions on three additional major Russian financial institutions – Otkritie, Novikom, and Sovcom and their identified subsidiaries – for either being controlled by, or acting on behalf of, the Russian Government as well as for operating having operated in the financial services sector of the Russian economy.

• The Treasury also notes that all entities owned 50 percent or more by the above financial institutions are subject to blocking, even if not identified by OFAC.

Debt and Equity Prohibitions Against Major State-Owned and Private Entities 

OFAC also issued Directive 3 under E.O. 14024, implementing new debt and equity restrictions on 13 major firms critical to the Russian economy.

• These restrictions “prohibit transactions and dealings by U.S. persons in new debt of longer than 14 days maturity and new equity of Russian state-owned enterprises, entities that operate in the financial services sector of the Russian Federation economy, and other entities determined to be subject to the prohibitions in this directive”.

The 13 identified firms are as follows

Pursuant to E.O. 14024, OFAC identified the following 11 Russian entities as being owned or controlled by, or having acted or purposed to act for or on behalf of, directly or indirectly, the GoR:

• Sberbank is Russia’s largest financial institution. Today, Sberbank was also identified as subject to the Russia-related CAPTA Directive.
• Gazprombank Joint Stock Company is Russia’s third-largest financial institution and is closely affiliated with the energy sector.
• Joint Stock Company Russian Agricultural Bank is Russia’s fifth-largest financial institution and closely affiliated with the agricultural sector.
• Public Joint Stock Company Gazprom is the world’s largest natural gas company.
• Public Joint Stock Company Gazprom Neft is one of Russia’s largest oil producers and refiners.
• Public Joint Stock Company Transneft (Transneft) manages Russia’s network of petroleum-related pipelines.
• Public Joint Stock Company Rostelecom is Russia’s largest telecommunications company.
• Public Joint Stock Company RusHydro is a hydroelectricity company and one of Russia’s largest power companies.
• Public Joint Stock Company Alrosa is the world’s largest diamond mining company, responsible for 90 percent of Russia’s diamond mining capacity, which accounts for 28 percent globally.
• Joint Stock Company Sovcomflot is Russia’s largest maritime and freight shipping company.
• Open Joint Stock Company Russian Railways is one of the world’s largest railroad companies.

Pursuant to E.O. 14024, OFAC identified the following three Russian entities for operating or having operated in the financial services sector of the Russian Federation economy:

• Joint Stock Company Alfa-Bank is Russia’s largest privately owned financial institution, and Russia’s fourth-largest financial institution overall.
• Credit Bank of Moscow Public Joint Stock Company is Russia’s largest non-state public bank and Russia’s sixth-largest financial institution.
• Sberbank, which is described above.

General Licenses 

To ensure that these sanctions and prohibitions have an impact on the intended targets and to minimize unintended consequences on third parties, OFAC has also issued the following general licenses in connection with these actions.

• General License 5: authorizes transactions for the conduct of the official business of certain international organizations and entities
• General License 6: “Transactions Related to the Exportation or Re-exportation of Agricultural Commodities, Medicine, Medical Devices, Replacement Parts and Components, or Software Updates, or the Coronavirus Disease 2019 (COVID-19) Pandemic” authorizes transactions ordinarily incident and necessary for the trade of agricultural commodities, medicine and medical devices.
• General License 7: “Authorizing Overflight Payments, Emergency Landings, and Air Ambulance Services” authorizes transactions ordinarily incident and necessary to:
  • the receipt of, and payment for, services rendered in connection with overflights of or emergency landings in the Russian Federation by aircraft registered in the United States or owned by U.S.
  • provide air ambulance and related medical services to individuals in the Russian Federation
• General License 8: “Authorizing Transactions Related to Energy” authorizes until June 24, 2022, transactions related to energy involving 5 specified entities and their subsidiaries of which they own a 50 percent or greater interest.
  • “For the purposes of this general license, the term “related to energy” means the extraction, production, refinement, liquefaction, gasification, regasification, conversion, enrichment, fabrication, transport, or purchase of petroleum, including crude oil, lease condensates, unfinished oils, natural gas liquids, petroleum products, natural gas, or other products capable of producing energy, such as coal, wood, or agricultural products used to manufacture biofuels, or uranium in any form, as well as the development, production, generation, transmission, or exchange of power, through any means, including nuclear, thermal, and renewable energy sources.”
• General License 9: “Authorizing Transactions Related to Dealings in Certain Debt or Equity” authorizes until May 25, 2022, dealings in debt and equity issued prior to February 24, 2022, with 5 specified Russian entities and their subsidiaries. Any divestment or transfer of covered debt or equity must be to a non-U.S. person.
• General License 10: “Authorizing Certain Transactions Related to Derivative Contracts” authorizes until May 25, 2022 all transactions ordinarily incident and necessary to the wind down of derivative contracts entered into prior to 4:00 p.m. EST, February 24, 2022. Any payments to a blocked person must be made into a blocked account.
• General License 11: “Authorizing the Wind Down of Transactions Involving Certain Blocked Persons” authorizes until March 26, 2022, all transactions ordinarily incident and necessary to the wind down of transactions involving Otkritie, Sovcombank, VTB, and any entity in which they one 50% or greater interest.
• General License 12: “Authorizing U.S. Persons to Reject Certain Transactions” authorizes until March 26, 2022, U.S. persons to reject all transactions prohibited by Executive Order (E.O.) 14024 involving one or more of Otkritie, Sovcombank, VTB, and any entity in which they one 50% or greater interest.

Actions Targeting Russian Elites 

On February 25, 2022, the United States continued to impose sanctions on President of the Russian Federation Vladimir Putin and the Minister of Foreign Affairs Sergei Lavrov, along with other members of Russia’s Security Council. These sanctions, along with previous sanctions on Russia’s economic continue to impose unprecedented diplomatic and economic costs on Russia and isolate it from the global financial system and international community.

Sanctions on Belarus 

On February 24, 2022, OFAC sanctioned 24 Belarusian individuals and entities due to Belarus’s support for, and facilitation of, the invasion. Among the sanctioned entities are two significant state-owned banks, as well as multiple entities and individuals associated with the Belarusian defense and security industries.

Along with this action OFAC also issued two general licenses related to the Belarus Sanctions Program:

• General License 6: “Official Business of the United States Government” authorizes transactions for the conduct of the U.S. Government’s official business.
• General License 7: “Official Business of Certain International Organizations and Entities” authorizes transactions for the conduct of the official business of certain international organizations and entities

Looking Ahead 

As these sanctions may only represent the initial stage of an ongoing and volatile economic landscape, we encourage the trade community to stay informed on all latest sanctions and how they may impact YOU. Should you need any assistance navigating OFAC sanctions please contact us at info@diaztradelaw.com.

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CBP 

• In Fiscal Year 2021, CBP at the LA/Long Beach Seaport seized More Than $760 Million in Counterfeit and Prohibited Products, a 652% increase over the previous year.
• CBP issues guidance regarding the extension of product exclusions from additional Section 301 China duties on certain medical-care products to address COVID-19.
• With changes to the HTSUS classification systems possibly coming as early as January 1, 2021, U.S. importers should review their classifications and ensure compliance with U.S. regulations

BIS

• The Bureau of Industry and Security (BIS) requests public comment regarding areas and priorities for U.S. and EU export control cooperation under the Trade and Technology Council.
  • Comments are due by January 14, 2022
• On November 26, 2021, the Department of Commerce’s Bureau of Industry and Security (BIS) published a final rule adding 27 foreign entities and individuals to the Entity List for engaging in activities that are contrary to the national security or foreign policy interests of the United States.

China

• In their most substantial talk since President Biden took office, Chinese President Xi Jinping has warned that encouraging Taiwanese independence would be “playing with fire”.
• On November 12, 2020, the President declared a national emergency to deal with the extraordinary threat to the national security, foreign policy, and economy of the United States constituted by certain companies of the People’s Republic of China.
• Airbnb subject to regulatory risk under U.S. law with more than a dozen homes available for rent in China’s Xinjiang region on land owned by an organization sanctioned by the U.S. government for complicity in genocide and forced labor.
• On December 6, 2021, President Biden announced a U.S. diplomatic boycott of the 2022 Beijing Winter Olympic Games over concerns about China’s human rights record.

Commerce Department

• The Department of Commerce invites the general public to comment on proposed, and continuing information collections to allow for submission of exclusions requests from the remedies adjusting imports of steel and aluminum into the United States.
• Comments are due by January 24, 2022.
• On December 1, 2021, the Department of Commerce announced the opportunity to request an annual administrative review for products that are currently subject to antidumping and countervailing duties.

FDA

• The FDA is sharing a grant opportunity to cover COVID-19-related expenses for eligible FDA-regulated food producers, processors and growers.
  • Applications are due November 22
    • How to Apply – USDA’s Pandemic Response and Safety Grant Program – YouTube
    • Eligibility – USDA’s Pandemic Response and Safety Grant Program – YouTube
    • DUNS Number Registration – USDA’s Pandemic Response and Safety Grant Program – YouTube

Export Controls/Sanctions

• On November 18, 2021, the U.S. Department of the Treasury’s Office of Foreign Assets Control sanctioned senior Houthi military officer Saleh Mesfer Alshaer, for the seizure of property in Yemen valued at greater than 100 million dollars, using a variety of unlawful tactics, including extortion.
• On November 18, 2021, the U.S. Department of the Treasury’s Office of Foreign Assets Control sanctioned six Iranian individuals and one Iranian entity for attempting to influence the 2020 U.S. presidential election.
• On November 24, 2021, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Syrian Sanctions Regulations to expand the authorizations for nongovernmental organizations (NGO) to engage in certain transactions and activities that ensure the continued provision of humanitarian assistance, including certain early-recovery activities, that benefit the Syrian people.
• On November 24, 2021, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued Venezuela-related General License 8I, authorizing  limited transactions with Petróleos de Venezuela, S.A. or the wind down of operations in Venezuela for certain entities.
• On December 2, 2021, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced the expansion of sanctions against Belarus to include 35 new designations to the Specially Designated Nationals and Blocked Entities List and the issuance of a related wind-down license, General License 5.
• On November 8, 2021, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) sanctioned 57 cryptocurrency addresses and one exchange for facilitating ransomware and money laundering

DST and Section 301 Investigations

• As part of the to address tax challenges arising from the digitalization of the world economy, the U.S. Trade Representative has determined to terminate the Section 301 Digital Services Tax Investigations of Austria, France, Italy, Spain, and the United Kingdom.
• U.S. and India reach agreement regarding the treatment of Digital Services Taxes prior to full implementation of Pillar 1 of the Organization for Economic Co-operation and Development (OECD) agreement.  As part of the agreement the United States will terminate the currently suspended additional duties on goods of India that had been adopted in the DST Section 301 investigation.
• On November 22, 2021, the U.S. Department of the Treasury (Treasury) issued a joint statement with Turkey regarding a transitional approach to Turkey’s Digital Service Tax (DST) prior to entry into force of Pillar 1. The joint statement reflects a political agreement in which the U.S. Trade Representative has determined to terminate the section 301 action taken in the investigation of Turkey’s DST.

USTR/Trade Policy

• On November 17, 2021, the United States and Japan announced the formation of the “U.S.-Japan Partnership on Trade” to deepen cooperation between the two countries and reaffirm their alliance through regular engagement on trade-related matters.
• United States Trade Representative Katherine Tai and United States Secretary of Commerce Gina Raimondo published an op-ed touting the agreement reached with the European Union that preserves the long-term viability of our steel and aluminum industries by tackling global excess capacity and creates a framework for reducing the carbon intensity of those sectors.

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Did you know in FY2020, U.S. Customs seized more than 26,000 shipments worth more than $1.3 BILLION due to alleged intellectual property rights (IPR) violations? Ensure you’re on the right side of CBP enforcement and register for Diaz Trade Law’s next webinar “Intellectual Property Rights (IPR) and Customs (Including an Update on the Amazon Registry) – Amazon Brand Registry“ taking place on December 15, 2021. This one-hour webinar will provide best practices and TOP tips on how one can protect their IPR using U.S. Customs and Border Protection (CBP) and effective methods to go after IPR infringers.

Register today to hear directly from DTL’s president, Jennifer Diaz, Associate Attorney, Denise Calle and Of Counsel and IPR Specialist, Augusto Perera, as they teach attendees about intellectual property rights and the best ways to protect them.

Why Should I Register for this Webinar?

In FY2019 and FY2020, U.S. Customs (CBP) seized more than 53,000 shipments worth more than $2.8 BILLION because of alleged IPR violations. The vast majority of goods seized have come from China and Hong Kong. During FY2020, CBP reported 18,757 active recordations – more than each of the previous two years.  Importers must be aware of how to import in compliance with IPR laws as well as how to protect their own intellectual property rights

In response to enforcement discussed above, Diaz Trade Law is hosting a NEI accredited webinar, “Intellectual Property Rights and Customs – Amazon Brand Registry” to train industry on top tips to avoid enforcement, and best practices to proactively protect their own brands.

In this webinar, you will learn the basics of intellectual property considerations for your business, how to use Amazon Brand Registry to build your brand, how protecting your brand is an ongoing commitment and the steps you need to take to ensure you do so proactively.

Importers, in-house legal counsel, owners, executives, marketing professionals, and others interested in intellectual property are encouraged to attend either live on December 15, 2021 at 12:00 PM, or on demand thereafter. Register HERE!

Did you know FDA has issued 1,569 enforcement actions against  medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

Register today to to hear directly from DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally market a medical device and best practices for avoiding and responding to enforcement actions.

Why Should I Register for this Webinar?

The FDA is actively enforcing its laws and regulations against non-compliant importers of medical devices. In FY21 alone the FDA has issued 53 warning letters  against medical devices companies.  Manufacturers, repackagers, relabelers, importers, and others engaged in the production or sale of medical devices must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, import alerts, seizures, voluntary recalls, injunctions, and criminal prosecution.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Warning Letters issued in FY21:

• Of the 53 warning letters issued to medical device companies in FY2021, 50% of these warning letters were issued against firms that marketed their medical devices as devices that treat or mitigate Covid-19. FDA found these devices (including  “KN95 Face Mask” and “3-ply Surgical Mask Disposable Face Mask”) to be “Unapproved Drugs, Misbranded, and/or Adulterated Products Related to Coronavirus Disease 2019 (COVID-19)”.
• In FY21, FDA warning letters have been issued against firms for offering medical devices for sale in the United States without marketing approval, clearance, or authorization from the FDA as well as poor current Good Manufacturing Practices (cGMPs).
• Interestingly enough 40 of the 52 warning letters were against U.S. and Chinese companies.

Recalled Medical Devices in 2020 and 2021:

• In FY21, FDA has recalled a total of 2161 medical devices, including the recall of 132 Class I devices, 1986 Class II devices, and 43 Class III devices have been recalled in FY21! 
• In FY20 a total of 3042 medical devices were recalled. 
• There are a total of 304 firms currently performing medical device recalls. Don’t be one of them!

In this webinar, you will receive an overview of FDA regulations and requirements for importing medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device. The objective of the webinar is to teach participants how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of medical devices are encouraged to attend either live on August 25, 2021 at 12:00 PM, or on demand thereafter. Register Here!