Pre-compliance

Customs Classification – A Key Component of an Import Compliance Manual

We are often asked by importers to assist in classifying their products under the Harmonized Tariff Schedule of the U.S. (“HTS” or “HTSUS”). While seeking assistance from expert counsel is a best practice, under the CBP Modernization Act, an importer of record (“IOR”) is the sole party responsible for determining the correct classification of imported goods (and thereby paying the correct amount of customs duties). An IOR must use reasonable care in classifying its product at the time of entry. Should an importer misclassify their products and not pay the appropriate duties to CBP at the time of importation; the importer is exposing itself to potential CBP penalties under 19 U.S.C. 1592.  The process of classifying goods can be a tedious process and may require time and research to arrive at the correct HTSUS number for any one product.

This blog expands our prior blog, Crash Course in the Harmonized Tariff Schedule of the United States, and provides additional detail on the classification process and tips for importers to use when deciding on a classification its customs broker will declare to CBP.

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How to Build and Maintain an Effective Import Compliance Plan

CBP enforcement is on the rise.  If your business is importing into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Building & Maintaining an Effective Import Compliance Plan”  will provide best practices and TOP tips to build an import compliance plan.

Register today to to hear directly from Senior Trade Advisor, Don Woods, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle as they discuss real life stories, current trends/risks associated with the import process, proactive ways to stay compliant, and the importance of training to avoid costly encounters with CBP. […]

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 […]

Comment Now – CBP Proposed Rule on Country of Origin Determination for Imports under USMCA

Background on CBP Country of Origin Determination and USMCA

All merchandise of foreign origin imported into the United States (U.S.) must generally be marked with its country of origin, and it is subject to a country of origin (COO) determination by CBP. The country of origin of imported goods may be used as a factor to determine eligibility for preferential trade treatment under a free trade agreement.

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Food Importers: How to Import Food Compliantly & Survive a FSVP Audit

The U.S. Food and Drug Administration (FDA) is now  auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. To date, over 92 warning letters have been issued against companies for FSVP violations. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Importing Food in Compliance with U.S. FDA & Surviving A FSVP Audit” will provide best practices and TOP tips to comply with FDA regulations and avoid, navigate, and mitigate any potential  FDA compliance action.

Register today to to hear directly from Senior Trade Advisor, Domenic Veneziano, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally import food and best practices for surviving a FSVP audit.

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