24 05, 2023

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

By |2023-05-24T12:27:23-04:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

 In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States. 

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.  

New MoCRA requirements include:  

  • FDA registration for cosmetics facilities 
  • Product listings for each cosmetic product 
  • Adverse event reporting 
  • Safety substantiation 
  • Compliance […]
19 05, 2023

Customs and Trade Weekly Snapshot

By |2023-05-19T12:34:01-04:00May 19, 2023|Snapshot|0 Comments

Here is a recap of the latest customs and international trade law news:

Customs and Border Protection (CBP)

  • CBP announced that it is changing its processes concerning the publication of the Notice of Seizure and Intent to Forfeit for CBP seizures and administrative forfeitures.
  • CBP Releases April 2023 Monthly Operational Update
  • CBP published a new Forced Labor Supporting Documents Submissions Guide
  • CBP Modifies Withhold Release Order in Response to Smart Glove’s Successful Actions to Address Forced Labor Supply Chain Issues – Smart Glove’s remediation efforts included repayment of recruitment fees, improvements to living conditions, and implementation of new worker-centered policies and procedures.
  • CBP Provides ACE Portal Modernization – CBP will deploy remaining functionality for ACE Portal Modernization – Phase 3 on May 21. However, prior to deployment, the Trade Transformation Office (TTO) held a demonstration via Microsoft Teams for trade users on Thursday, May 18.
  • Did you know CBP provides weekly foreign-currency-exchange-rates?
  • The Congressional Budget Office released a cost estimate for the CTPAT Pilot Program Act of 2023.
  • CBP issued the notice of determination as to evasion for EAPA consolidated case 7724 filed by the Paper Receipts Converting Association, against U.S. importer, WHP Associates LLC (WHP) for evasion of the applicable AD/CVD orders.
  • CBP Delays Updated OHBOL Release – CBP said the updated Ocean House Bill of Lading (OHBOL) Release, as well as the OHBOL Release Container Freight Station User Interface (CFS UI), in ACE has been delayed and a new date will […]
19 05, 2023

Can A False Claims Act Qui Tam Case, Alleging Customs Fraud, Be Filed And Pursued Anonymously?

By |2023-05-19T12:31:21-04:00May 19, 2023|U.S. Department of Justice (DOJ)|0 Comments

Co-authored by:
Jonathan Tycko – Tycko & Zavareei LLP
Jennifer Diaz – Diaz Trade Law

Introduction

A company you work for, or maybe a competing company, is committing customs fraud.  The company is lying about the value of the products it is importing, using improper HTS codes to avoid duties, or importing products that have been transshipped to evade tariffs.  What can you do about it?  One option is to file what is known as a “qui tam” lawsuit under the federal False Claims Act.  A qui tam lawsuit is one that is brought by a private citizen or company against defendant that owe money to the government.  When a qui tam lawsuit is successful, the party that initiated the case—called a “relator”—is entitled to a substantial monetary reward, ranging between 15% and 30% of the amount recovered for the government.  A qui tam lawsuit has another major advantage: it engages the U.S. Department of Justice (“DOJ”) in the case, and typically results in the opening of an investigation by DOJ into the allegations made in the case.  So, a qui tam lawsuit is a means of bringing allegations of customs fraud to the attention of the government, and triggering a serious inquiry by the government into those allegations.

 

False Claims Act qui tam cases can be complicated, and many factors go into whether such a case can be successful.  In this article, we do not address the substance of the cases themselves.  Instead, we address a question we are commonly asked […]

12 05, 2023

Customs and Trade Weekly Snapshot

By |2023-05-12T11:07:48-04:00May 12, 2023|Snapshot|Comments Off on Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

Customs and Border Protection (CBP)

  • CBP Seeks Feedback on ‘Ask ACE Chatbot’. CBP has asked the community to try out the now live “Ask ACE chatbot” on the CBP ACE homepage. The Ask ACE chatbot is intended to assist ACE users with general questions related to ACE and redirect users to existing resources that provide more comprehensive information. As it is an automated, digital tool, it will be available to the public online 24/7.
  • CBP maintains a notional development and deployment schedule (Dev/Dep schedule) of planned ACE enhancements. This schedule reflects those enhancements that have been prioritized and funded, and that CBP has begun developing. In addition to those enhancements found on the Dev/Dep schedule, CBP continues to work through emerging requirements. These emerging requirements will be added to the Dev/Dep schedule as new ACE enhancements when funding is secured and work is underway.
  • CBP issued a Final Administrative Determination in: Enforce and Protect Act (“EAPA”) Case Number 7699 concerning antidumping duty orders for Forged Steel Fittings From Italy and the People’s Republic of China. The determination affirmed in part and reversed in part the previous ruling from December.
  • CBP Seeks Feedback from Customs Broker License Exam Test Takers – to continuously improve the experience of its customs broker license exam, CBP has asked for individuals who took the exam on April 26 to share their experiences. Test takers should email their feedback regarding the […]
11 05, 2023

Submitting Voluntary Self-Disclosures to Bureau of Industry & Security

By |2023-05-11T12:56:55-04:00May 11, 2023|Bloomberg Export|Comments Off on Submitting Voluntary Self-Disclosures to Bureau of Industry & Security

Diaz Trade Law is enthusiastic to announce Bloomberg Law published an update to our previous article, “Submitting Voluntary Self-Disclosures to Bureau of Industry & Security.” The udpate discusses new guidance from BIS regarding failure to voluntary disclose significant violations. Below is the article reproduced with permission for your reading pleasure. You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

8 05, 2023

Customs and Trade Weekly Snapshot

By |2023-05-08T12:55:22-04:00May 8, 2023|Snapshot|Comments Off on Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

Customs and Border Protection (CBP)

Department of Homeland Security

 Food and Drug Administration (FDA)

  • FDA Completes Posting of Deemed Final Orders, completing the process of posting 33 deemed final orders for 32 different monograph therapeutic categories and one for non-monograph conditions as part of over-the-counter (OTC) monograph reform under the CARES Act.
  • S. Marshals, at the FDA’s request, seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 1000 kilograms of bulk kratom.
  • The FDA published a Conversations with Experts QAthat focuses on the importance of the agency’s engagement with international organizations, including World Health Organization, the Food and Agriculture Organization of the United Nations, the World Trade Organization’s Standards and Trade Development Facility, and the Asia Pacific Economic Cooperation’s Food Safety Cooperation Forum, among others.

United States Trade Representative (USTR)

  • USTR holds a Phoenix Small Business Roundtable with United States Trade Representative Katherine Tai and Administrator Isabella Casillas […]
27 04, 2023

Customs and Trade Weekly Snapshot

By |2023-04-27T21:54:51-04:00April 27, 2023|Snapshot|Comments Off on Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

Customs and Border Protection (CBP)

  • Customs Trade Partnership Against Terrorism (CTPAT) announced a newly designed logo for the exclusive use of their validated partners. A partner must abide by the CTPAT licensing agreement, which must be signed by the primary company officer/main point of contact. Upon returning the signed license to the aforementioned e-mail, the graphics file will be sent to the licensee.
  • CBP Modifies Withhold Release Order in Response to Smart Glove’s Successful Actions to Address Forced Labor Supply Chain Issues
  • S. Customs and Border Protection (CBP) signed a Mutual Recognition Arrangement (MRA) with the Customs Administrations of Guatemala and Colombia at the Trade Facilitation and Cargo Security Summit.
  • Since June, CBP has seized nearly $1 billion in goods tied to forced labor

Department of Justice

 Federal Trade Commission (FTC)

  • FTC Warns Almost 700 Health Product Companies That They Could Face Civil Penalties if They Can’t Back Up Their Product Claims
  • FTC Chair Khan and Officials from DOJ, CFPB and EEOC Release Joint Statement on AI pledging to uphold America’s commitment to the core principles of fairness, equity, and justice as emerging AI systems become more common.

Congressional-Executive Commission on China

  • Held a hearing on the implementation of the Uyghur Forced Labor Prevention Act and the impact on global supply chains.

Bureau of Industry & […]

27 04, 2023

FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations  

By |2023-04-27T21:51:35-04:00April 27, 2023|Food, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations  

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA officially began enforcement on January 1, 2023 but gave a 60-day grace period before beginning to verify numbers.

What is a DUNS Number?

DUNS stands for Data Universal Numbering System. It is a proprietary system developed by Dun & Bradstreet (D&B) that assigns a unique number to a business entity that is recognized worldwide. The DUNS system is not unique to the FDA. Other DUNS users include the UN, Apple, and the European Commission.

Why is the FDA Requiring This Now?

The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. The DUNS requirement dates back to 2016 when the agency issued a rule implementing new food facility registration requirements. Under the rule, the FDA requires facilities to provide a unique facility identifier (UFI) when registering. Subsequent guidance provided that a DUNS number is an acceptable UFI for registration.

The utilization of DUNS numbers will help the FDA:

  • Improve accuracy and consistency in the registration database
  • Identify facilities that pose a risk
  • Verify the authenticity of registrations
  • Ensure that facility information is up to date

The FDA has been working with facilities who have had difficulty obtaining a DUNS number and has issued guidance allowing registrants to enter a “PENDING” status if they cannot obtain a number in time.

What Do Food Facilities Need to Do?

Food facilities that […]

21 04, 2023

Customs and Trade Weekly Snapshot

By |2023-04-27T21:52:53-04:00April 21, 2023|Snapshot|Comments Off on Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

U.S. Customs and Border Protection (CBP)

  • CBP provides guidance on cybersecurity best practices to increase supply chain resiliency
    • The new guidance document makes recommendations on how to prevent, respond to, and recover from potential cyber-attacks on customs broker data systems, from proactively putting in place plans and preventative IT controls to resuming normal business operations upon system remediation.
  • CBP’s ACE Portal is getting a major modernization upgrade, making it easier than ever to manage operations online.
  • CBP released March 2023 monthly operational update. In March 2023, CBP:
    • Processed more than 2.7 million entry summaries valued at more than $274 billion
    • Identified 400 shipments valued at more than $122 million for further examination based on the suspected use of forced labor
    • Seized 1,798 shipments that contained counterfeit goods valued at more than $335 million
    • Completed 29 audits that identified $24.7 million in duties and fees owed to the U.S. government
  • CBP issued cyber incident guidance for customs brokers which provides best practices to enhance preparedness for a cyber incident on a licensed customs broker data system.
  • Modernized ACE Portal Broker Employee Reporting Requirements to be Satisfied by 4/14/2023
  • CBP issues April 2023 reference material information for Customs Broker License Exam
  • The National Commodity Specialist Division, Office of Trade, presented the next round of commodity-specific, educational webinars to support our internal and external stakeholders.

Food and Drug Administration (FDA)

  • The FDA published “Catching Up […]
6 04, 2023

Customs and Trade Weekly Snapshot

By |2023-04-06T11:56:00-04:00April 6, 2023|Snapshot|Comments Off on Customs and Trade Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

U.S. Customs and Border Protection (CBP):

  • CBP issues CSMS 55754324 announcing the UFLPA Country Code Requirements The UFLPA Region Alert will add three new validations to ACE in specific applications. The validations will be:
    • Postal code will be a required field.
    • Users will receive an error message if the postal code provided is not a valid Chinese postal code.
    • Users will receive a warning message when a XUAR region postal code is provided.

 Food and Drug Administration (FDA):

The Bureau of Industry and Security (BIS):

  • (BIS) published a rule that adds eleven entities based in Burma, the People’s Republic of China (PRC), Nicaragua, and Russia to the Entity List for enabling or engaging in human rights abuses around the world.
    • The rule also reaffirms BIS’s longstanding position that the protection of human rights throughout the world is a foreign policy interest.
  • Biden Administration and international partners release export controls and Human Rights Initiative Code of Conduct.

Office of Foreign Assets Control (OFAC):

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