Catch Up on All DTL Blogs from 2021
We want to make sure you stay up to date with the hottest trade blogs from 2021. Below is a summary of what you missed by category. Enjoy!BIS
BIS Publishes Report on Effect of Uranium Imports on National Security
BIS Publishes First Military End User List
Bloomberg
Bloomberg Law – Introduction to U.S. Export Controls: Part 2
Protecting Intellectual Property Rights in China
Incoterms 2020
Submitting Voluntary Self-Disclosures to Bureau of Industry & Security
Submitting a Voluntary Self-Disclosure to Census
Submitting a Voluntary Self-Disclosure to OFAC
U.S. Customs Targets Use of Forced Labor
Customs and International Trade Bar Association
New CITBA Article – An Overview of China’s New Export Controls Regime
COVID-19’s Impact on 2020 Trade Flows
China
OFAC Issues Clarifying Guidance on Communist Chinese Military Companies Sanctions
Hong Kong’s Initiates Dispute Regarding U.S.-Origin Marking Requirement
CBP Issues WRO on Cotton, Tomato, & Downstream Products Made in Xinjiang
Future of First Sale Rule in Question
Crypto
OFAC Targets Russian Crypto Platform
Why China’s Cryptocurrency Miners are Moving to Texas
Covid-19
Recent Government Data Indicates that Florida Trade is Rebounding Fast Despite Pandemic Hit
Export
What are Routed Export Transactions?
Understanding the Computer Export License Exception (APP)
Understanding the GOV Export License Exception
Vegas Woman Charged with Iran Sanctions Violations
Do’s and Don’ts of Filing a Commodity Jurisdiction Request
Understanding Strategic Trade Authorization
Building a Strong Export Compliance Plan
Commerce Department Issues Rule Securing Digital Supply Chains Against Foreign Adversaries
Import/CBP
UK Joins Kimberley Diamond-Trading Process
FTC issues a Record Breaking $1.2 Million Penalty
Customs Issues Notice of Proposed Rulemaking on Broker Continuing Education – Comments Open
Comment Now – CBP Proposed Rule on Country of Origin Determination for Imports under USMCA
9801.00.10: Updated Requirements for Returned Goods
Customs Valuation 101
Breaking News – New Federal Law Expands Furniture Flammability Testing Standard
AD/CVD
New Antidumping Petition Against Imports of Certain Honey Products
New AD/CVD Petition Against Imports of Certain Chinese Mobile Access Equipment
Buy America
Biden Executive Order Strengthens Buy American Government Procurement Laws
U.S. Fish and Wildlife Service
Trading in Wildlife? You May Need a License
U.S. Food and Drug Administration
FDA Seeks Public Comments on Proposed Final Order for OTC Sunscreen Safety
FDA OPENS NEW FSVP PORTAL FOR IMPORTERS
FDA Further Extends UFI Flexibility For Food Facility Registrations
OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021
FDA Import Alert on Mexican Hand Sanitizer
Comment on FDA’s Proposed Rule – French Dressing
USITC
An Introduction to Safeguard Investigations
OFAC
Between a Rock and a Hard Place – Conflicting U.S. & EU Sanctions Policies Towards Iran
OFAC Sanctions & Licensing
The CAPTA List – An Introduction
Treasury Imposes Further Sanctions on Iran
Trump Administration Designates Cuba State Sponsor of Terrorism
Section 301
Want Your 301 Exclusion Back? Comment Now!
Potential Relief from China Tariffs Coming
301 Exclusion Extensions for COVID-19 Related Products
Proposed 25% Tariffs on Section 301 Digital Service Taxes – Comment Now
USTR Announces Special 301 Review – Comments Due January 28
US Imposes Additional Tariffs on EU Goods
USCIT Invalidates 232 Tariffs on Steel and Aluminum Derivatives
Podcasts
3-Part Podcast Miniseries – Importing, Exporting, and AD/CVD
Trade Snapshots
Customs and Trade Law Snapshot
Customs and Trade Law Weekly Snapshot
USDA
Understanding Organic Equivalency Arrangements
USDA National Organic Program – Enforcement & Compliance Overview
Webinars
Want Customs to Police Your IPR at all 328 Ports of Entry?
Customs Classification – A Key Component of an Import Compliance Manual
Keysight Technologies Pays $6.6M to State Department for Export Violations
Food Importers: How to Import Food Compliantly & Survive a FSVP Audit
Don’t Let FDA Target Your Medical Device Company
Insight on Last 6 Months of Biden/Congress on Trade
Diaz Trade Law Invites the Trade Community to Two Free Webinars this Summer!
Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement
ACE: Auditing Your Export History
ACE: Auditing Your Import History
Exporting 101 – Introduction to Export Controls
Anti-Circumvention, EAPA, Dumping Duties & the Spreadability of Cases
Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?
REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs
Biden Administration Commits to Modernizing Regulatory Review
If you have any questions on the topics above, contact us at info@diaztradelaw.com.
The post Catch Up on All DTL Blogs from 2021 appeared first on Customs & International Trade Law Blog.
Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products 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, 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.
Why Should Industry Register for the Webinar?
Warning Letters in 2021:
Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.
Import Alerts in 2021:
FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:
Import Alert Number
Import Alert Name
66-40
“Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs”
66-41
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”
This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, 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 Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.
Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!
The post Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement appeared first on Customs & International Trade Law Blog.
FDA Further Extends UFI Flexibility For Food Facility Registrations
Background on Food Facility Registration
The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.
Among other requirements, covered facilities are required to provide a Unique Facility Identifier (“UFI”) recognized as acceptable by the FDA. This requirement applies both new facilities registering for the first time, and facilities renewing their registration. The UFI is used by the FDA to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. The UFI should be input in the UFI field in Section 2 of FDA Form 3537.
In August of 2018, the FDA issued guidance recognizing the Data Universal Numbering System (“DUNS”) number as an acceptable UFI. The DUNS number is administered by Dun & Bradstreet (“D&B”), a private data analytics and business intelligence service provider. DUNS numbers can be obtained by visiting the portal on D&B’s website.
This requirement began during the latest biennial registration renewal period, which ended on December 31, 2020. However, the FDA had allowed facilities more time to obtain and submit a UFI with their registration submission.
FDA Extends Flexibility Through December 2022
The FDA announced in March 2021 that it is further extending the time period to obtain and submit a UFI until December 31, 2022. The FDA stated that it does not intend to enforce the UFI verification requirements for the remainder of the 2020 biennial registration renewal cycle. The guidance provides information on how registrants may obtain and provide a UFI even if they were unable to obtain a UFI before December 31, 2020.
Interested parties have voiced concerns about obtaining a DUNS number in a timely manner. While the FDA expects all registrants to provide their DUNS numbers with their registration or renewal, the FDA has recognized that there may be a delay in obtaining a DUNS number. Accordingly, the FDA is allowing registrants who anticipate that they will be temporarily unable to provide a DUNS number an alternative recourse. To address stakeholder concerns with obtaining a DUNS number in a timely manner, FDA intends to allow registrants who anticipate that they will be temporarily unable to provide a DUNS number with their registration or renewal to enter “PENDING” in the UFI field of their registration. This temporary entry will allow for registrations and renewals to be submitted even if the registrant has not yet provided a DUNS number. Upon submission, registrants will have until December 31, 2022 to update their registration with their DUNS number.
Contact Us
Failure to update the registration with a valid DUNS number by the end of the next biennial registrational renewal cycle will result in cancellation of the registration for failure to renew. Diaz Trade Law has significant experience in FDA-related matters. If you require assisting obtaining a DUNS number, or if you require assistance renewing or submitting your registration as a first-time filer, contact us today at info@diaztradelaw.com or 305-456-3830.
Antecedentes del Registro de Instalaciones Alimentarias
La Ley Federal de Alimentos, Medicamentos y Cosméticos (“FD&C”) requiere que las instalaciones nacionales y extranjeras que fabrican, procesan, envasan o almacenan alimentos para consumo humano o animal en los Estados Unidos se registren con la Administración de Alimentos y Medicamentos de los Estados Unidos (“FDA ”). La Ley de Modernización de la Seguridad Alimentaria (“FSMA”) de la FDA modificó los requisitos de registro de instalaciones de alimentos en FD&C para exigir que las instalaciones nacionales y extranjeras presenten cierta información adicional a la FDA y que renueven sus registros cada dos años durante el período que comienza el 1ero de Octubre y termina el 31 de Diciembre de cada año par.
Entre otros requisitos, las instalaciones deben proporcionar un identificador único de instalación (“UFI”) aceptado por la FDA. Este requisito se aplica tanto a las nuevas instalaciones que se registran por primera vez como a las instalaciones que renuevan su registro. La UFI es utilizada por la FDA para verificar que la dirección específica de la instalación asociada con la UFI es la misma dirección asociada con el registro de la instalación. El UFI debe ingresarse en el campo UFI en la Sección 2 del Formulario 3537 de la FDA.
En Agosto del 2018, la FDA emitió una guía que reconoce el número del Sistema de numeración universal de datos (“DUNS”) como un UFI aceptable. El número DUNS es administrado por Dun & Bradstreet (“D & B”), un proveedor de servicios de inteligencia empresarial y análisis de datos privados. Los números DUNS se pueden obtener visitando el portal en el sitio web de D & B.
Este requisito comenzó durante el último período de renovación del registro bienal, que finalizó el 31 de Diciembre del 2020. Sin embargo, la FDA le había otorgado a las instalaciones más tiempo para obtener y enviar un UFI con su presentación de registro.
La FDA Extiende la Flexibilidad Hasta Diciembre del 2022
En marzo del 2021, la FDA anunció que está ampliando hasta el 31 de Diciembre del 2022 el período de tiempo para obtener y enviar un UFI. La FDA declaró que no tiene la intención de hacer cumplir los requisitos de verificación de UFI durante el resto del ciclo de renovación de registro bienal del 2020 . La guía proporciona información sobre cómo los registrantes pueden obtener y proporcionar una UFI incluso si no pudieron obtener una UFI antes del 31 de Diciembre del 2020.
Las partes interesadas han expresado su preocupación por obtener un número DUNS de manera oportuna. Si bien la FDA espera que todos los solicitantes de registro proporcionen sus números DUNS con su registro o renovación, la FDA ha reconocido que puede haber una demora en la obtención de un número DUNS.
En consecuencia, la FDA está ofreciendo un recurso alternativo a los solicitantes del registro que anticipan que temporalmente no podrán proporcionar un número DUNS . Para abordar las inquietudes de las partes interesadas sobre la obtención de un número DUNS de manera oportuna, la FDA tiene la intención de permitir a los solicitantes de registro que anticipen que no podrán proporcionar temporalmente Número DUNS con su registro o renovación y puedan ingresar “PENDIENTE” en el campo UFI de su registro. Esta entrada temporal permitirá que se presenten registros y renovaciones incluso si el registrante aún no ha proporcionado un número DUNS. Tras la presentación, los inscritos tendrán hasta el 31 de Diciembre del 2022 para actualizar su registro con su número DUNS.
Contáctenos
Si no actualiza el registro con un número DUNS válido al final del próximo ciclo de renovación del registro bienal, se le cancelará el registro por no renovarlo. Díaz Trade Law tiene una experiencia significativa en asuntos relacionados con la FDA. Si necesita ayuda para obtener un número DUNS, o si desea que lo asistamos a renovar o enviar su registro como contribuyente por primera vez, contáctenos hoy a través del siguiente correo electrónico info@diaztradelaw.com o a través del siguiente número telefónico 305-456-3830.
The post FDA Further Extends UFI Flexibility For Food Facility Registrations appeared first on Customs & International Trade Law Blog.
CATCH UP ON DTL’S TOP BLOGS FROM 2018!
We want to make sure you stay up to date with the hottest trade topics from 2018. below is a summary of what you missed by category. Enjoy!
CBP
Why You Need Your Very Own Ace Account
USMCA Replaces NAFTA
Air Cargo Advanced Screening
Should You Get A Binding Ruling?
My Goods Have Been Seized, What Should I Do?!
Goodbye Airport Lines. Hello Trusted Traveler Programs.
34,143 IPR Seizures In 2017, Sets Record!
CBP Sued Over Mandatory Hold Harmless Release Agreement
CBP Now Issuing Penalties For Wood Packaging Material Violations
Right To Make Entry: Are You Entitled To Import Goods?
Making E-Commerce Safer: CBP Releases New E-Commerce Strategy
A Smoother Road To Exporting Vehicles: CBP’s New Electronic Validation Export Program
Your Cheat Sheet To Comply With CBP’s Forced Labor Requirements
Does Dirty Money Infiltrate Your Market Place?
Best Practices for Freight Forwarders
Why Your Freight Forwarder Must Segregate Hazardous Materials
My Freight Forwarder Is Requesting A Shipper’s Letter Of Instruction, Now What?
Trade War with China
Are You On The List?
Will A Transatlantic Trade War Put The American Agricultural Industry At Risk?
On The Brink Of A Trade War: Trump’s New Tariff Plan On Chinese Imports
Year In Trade 2017 – Highlights Of U.S. Trade Relations With China And Canada In 2017
ZTE Barred By U.S. Government & ZTE Fights Back!
Update – Deadline Approaching – A Snapshot Of Section 301 Duties & Your Options!
Update! Deadline Approaching – Why Should Your Product Not Be On The 301 List!
U.S. Issues Additional Chinese Tariffs – Is Your Product On The List?/ EE.UU. Emite Aranceles Adicionales A Bienes Chinos: ¿Su Producto Está En La Lista?
Will President Trump Impose New Tariffs On Imported Vehicles?
USDA
Bioengineered Food Labeling
USDA Proposed Rule To Inform Consumers Of GMO’s (Costing Industry 1.7 Billion)
FDA
FDA Issues Guidance Documents On Food Facility Registration
FDA Issues New Guidance To Help Food Facilities Meet Registration Requirements
FDA Takes New Steps In Oversight Of Imported Foods
FDA Announces Enforcement Discretion Under FSMA
Food Importers – Want To Expedite Your Importations With FDA?
Export Controls
Chinese Telecom Giant, ZTE, Faced With Largest Penalty Ever Levied
OFAC Increases Civil Monetary Penalties
If you have any questions on the topics above, contact us at info@diaztradelaw.com
The post CATCH UP ON DTL’S TOP BLOGS FROM 2018! appeared first on Customs & International Trade Law Blog.
FDA Issues Guidance Documents on Food Facility Registration
heading3 Constituent Update August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act). One of the documents being published today is the seventh edition of a guidance to help the owners and operators of […]
FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements
On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in […]