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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. […]

By Jennifer Diaz|2021-10-01T09:44:43-04:00October 1, 2021|ACE, Best Practices, Brokers, CBP 28, CBP 29, CEE, Counterfeits, Country of Origin, CTPAT, Currency Seizure, Customs Broker, Customs Expert, Detention, Enforcement, Forced Labor, Freight Forwarding, Import, Intellectual Property Rights, International Trade, IPR, Trademarks and Logos, ISF, Labeling, Liquidated damages, penalty, Pre-compliance, Reasonable Care, Seizure, U.S. Customs and Border Protection (CBP)|0 Comments

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

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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By Jennifer Diaz|2021-09-06T08:45:58-04:00September 6, 2021|Best Practices, Food, Import, International Trade, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

Understanding Organic Equivalency Arrangements

An Introduction to the National Organic Program Established by Congress and announced in 2000, the U.S. Department of Agriculture’s (“USDA”) National Organic Program (“NOP”) is a federal regulatory program which develops and enforces uniform national standards for organically-produced agricultural products sold in the United States. NOP operates as a public-private partnership which accredits third-party organizations to certify that farms and businesses meet the national organic standards. By enforcing its standards, NOP ensures a level playing field for producers while protecting consumer confidence in the integrity of the USDA organic seal.

The NOP’s Compliance & Enforcement Division (“C&E”) is involved in enforcement organic standards. C&E enforces rules by working with independent certifying agencies. Independent certifying agencies accredited by the USDA conduct periodic inspections or audits.

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By Jennifer Diaz|2021-08-31T08:45:12-04:00August 31, 2021|Best Practices, Export, Import, International Trade, Labeling, U.S. Department of Agriculture (USDA)|0 Comments

Don’t Let FDA Target Your Medical Device Company

Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

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By Jennifer Diaz|2021-08-10T08:45:36-04:00August 10, 2021|Best Practices, COVID-19, Import, Import Alert, International Business, International Law, International Trade, Labeling, Medical Devices, PPE, Pre-compliance, Speaking, U.S. Food and Drug Administration (FDA)|0 Comments

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