On March 10, 2021, via Federal Register Notice ( 86 FR 13785), the United States Trade Representative (USTR) announced that 99 medical product exclusions will be extended from March 31, 2021, to September 30, 2021. This action extends a previous USTR action which extended these exclusions from December 31, 2020, to March 31, 2020 (85 FR 85831). […]
A year into the COVID-19 pandemic, the U.S. Environmental Protection Agency (EPA) and The Food and Drug Administration (FDA) are in full enforcement mode carefully monitoring novel products claiming to treat, mitigate, or “kill” COVID-19. Compliance advisories issued at the beginning of the pandemic are now being replaced with enforcement advisories. Manufacturers, importers, distributors, and others engaged in the production or sale of products claiming to mitigate or “kill” COVID-19 should be more cautious than ever when developing product claims for both product labels and marketing material or alternatively, confirm products comply with the numerous regulations governing COVID-19 cleaning products.
For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.
On December 29, 2020, the Office of the United States Trade Representative (“USTR”) announced long-awaited extensions to a limited set of previously granted exclusions (for COVID-related products), that were set to expire on December 31, 2020. Meanwhile, importers across non-COVID industries are continuing to await guidance on their tariff exclusion extensions that are set to expire on December 31, 2020.
BIS’ Announcement
Last month, the U.S. Commerce Department’s Bureau of Industry & Security (“BIS”) announced that it is providing six-month extensions for export license applications due to economic difficulties associated with the COVID-19 pandemic. As a result of this announcement, BIS is permitting exporters to request six-month validity period extensions for licenses due to expire on or before December 31, 2020. BIS accepts all submission requests in one central electronic mailbox: LicenseExtensionRequest@bis.doc.gov. When a party submits a license extension request, BIS will review the original license and (in most cases), extend the validity of the license by six months. BIS estimates that the majority of extension validity requests will be processed and approved within two to three business days. Acting Under Secretary for Industry and Security Corden Hull said, “The streamlined process will help ensure that exporters with licenses due to expire on or before the end of 2020, who may not have been able to ship orders due to resource constraints during the pandemic, have the opportunity to benefit fully from the authorizations granted on their licenses.”
During the weeklong series of 10 informative webinars on trade regulations, we heard TOP TIPs from numerous federal agencies, including U.S. Customs & Border Protection (CBP), U.S. Food and Drug Administration (FDA)’s Division of Southeast Imports, Miami’s CBP Fines, Penalties & Forfeitures (FP&F) Office, Miami CTPAT Field Office and more! Each webinar was produced to assist importers and exporters understand compliance and hot issues. Below are summaries of two webinars – FDA Import Operations Associated with COVID-19 Efforts and CTPAT – State of the Program / Minimum Security Criteria Updates:
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Diaz Trade Law’s President, Jennifer Diaz and Associate Attorney, Denise Calle are enthusiastic to announce that another one of their articles, “PPE Imports During COVID-19,” was published by Bloomberg Law! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!
You can read the article here, by clicking PPE Imports Article (where you’ll have the ability to access all of the great hyperlinks) you cannot click on below.
We’d love to hear your feedback!
The Office of the United States Trade Representative (USTR), faced with the current COVID-19 pandemic, has moved quickly to grant numerous exclusion requests in March 2020; many of which are for medical supplies. USTR is also seeking comments from industry on whether products are necessary to combat COVID-19 spread and should be excluded from the additional duties. DTL has assisted clients in submitting comments to the USTR – this is the time to let your voice be heard.
Below is a chart summarizing recent changes to Section 301 Tariffs: