U.S. Food and Drug Administration (FDA) Archives - Page 12 of 42

Customs and Trade Law Weekly Snapshot

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

Apparel

Nike has ended 2021 as the most valuable apparel firm globally. According to data presented by FinancePR.com, the American outfit achieved a $30.44 billion valuation in 2021, placing it at the helm of the top ten garment firms worldwide.

CBP

On November 30, 2021, U.S. Customs and Border Protection officers in Cincinnati seized a shipment containing counterfeit designer jewelry and scarves. The fakes, which came from China, would have been worth a total of $3.09 million had they been genuine.
On December 6, 2021, a garment importer based in downtown Los Angeles was sentenced to 12 months and one day in federal prison for scheming to undervalue imported garments and avoid paying duties to the United States, and failing to report income on tax returns and large cash transactions to the federal government.
On December 13, 2021, Chris Magnus was sworn in as Commissioner of United States Customs and Border Protection following his Senate confirmation last week. Magnus becomes the fifth confirmed CBP Commissioner since the law enforcement agency’s creation under DHS in 2003.
CBP has reorganized all Informed Compliance Publications (ICPs) on CBP.gov under each applicable Center of Excellence and Expertise.
U.S. Customs and Border Protection is modernizing the ACE Secure Data Portal over multiple phases in 2022. The modernization effort will entail the transition of existing functionality to an upgraded platform, offering […]

By Jennifer Diaz|2022-07-01T10:39:10-04:00January 14, 2022|ACE, China Trade War, FDA Issues, HTSUS, Import, International Trade, Seizure, U.S. Customs and Border Protection (CBP), U.S. Department of Commerce (DOC), U.S. Food and Drug Administration (FDA), U.S. Office of the United States Trade Representative (USTR), Uncategorized|0 Comments

2021: A Year in Review

From all of us at Diaz Trade Law, we are incredibly thankful and grateful for your support this year. Despite this ongoing pandemic, Diaz Trade Law still managed to save our clients MILLIONS of dollars in 2021. It is with great joy that we finish off 2021 filled with numerous achievements and accomplishments were humbled to share with you. We look forward to assisting you in what we envision will be a better and brighter 2022!

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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!

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Customs and Trade Law Weekly Snapshot

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

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 […]

FDA Seeks Public Comments on Proposed Final Order for OTC Sunscreen Safety

FDA is proposing to amend the Over-the-Counter (OTC) Monograph which covers sunscreen drug products for OTC human use. The public has until November 12, 2021 to submit comments on the impact the proposed changes may have on consumers and industry. This blog provides background on why FDA is considering such changes and discusses FDA’s newly deemed final order for OTC sunscreens as well as the changes included in the proposed order for sunscreens. Industry is encouraged to contact Diaz Trade Law to assess the implications of the proposed changes on its products and to assist in drafting and submitting comments to FDA.

Why is FDA Taking New Steps to Enhance Sunscreen Safety?

The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed and modernized the way FDA regulates certain OTC monograph drugs, including sunscreen.

The CARES Act replaced the rulemaking process for OTC monograph drugs with an administrative order process for issuing, revising, and amending the OTC monographs. The administrative order process gives FDA new tools to help revise the OTC monographs as science changes, innovation progresses, new data becomes available, or emerging safety signals arise.

For sunscreens specifically, in addition to establishing a deemed final order, the CARES Act requires FDA to issue a proposed order to amend and revise the deemed final order for sunscreens. The FDA believes that most sunscreens on the market will be in compliance with the deemed final order because the provisions are nearly identical to the pre-CARES Act marketing conditions for sunscreens.

As background, an OTC […]

By Jennifer Diaz|2021-09-29T13:07:06-04:00September 29, 2021|Enforcement, Import, Labeling, OTC Sunscreens, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments