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 […]

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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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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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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Jennifer Diaz Presenting at Global Trade Educational Conference 2021

The NCBFAA Educational Institute invites all global logistics professionals to its 7th Annual Global Trade Educational Conference (GTEC). This two-day event in  Baltimore, MD will give customs brokers, freight forwarders, NVOCCs, OTI, service providers, importers, exporters and all global logistics professionals an opportunity to update themselves on industry developments and connect with colleagues new and old.

Join us IN PERSON in Baltimore, MD, July 26-27, 2021. NCBFAA NEI and hotel staff will be complying with all state and venue COVID-19 protocols so you can feel safe attending the event! Virtual attendance is available, so you can gain knowledge from anywhere!

REGISTER TODAY!

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FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA)  Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs

Webinar Importing 101 Introduction to US CustomsWhether you are new to importing or seasoned, this one-hour webinar is a must attend. Register today to hear directly from this specialized, expert trio on the “Top 10 Tips When Importing to Ensure Compliance” with real case studies:

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Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?

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.

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