Labeling Archives | Customs & International Trade Law Blog

FTC Cracks Down on False “Made in the USA” Claims

The Federal Trade Commission (FTC) recently announced law enforcement actions involving three companies that falsely claimed that their products were made in the United States.

Made in the USA

The “Made in the USA” labeling rules were enacted to prevent deceptive advertising and ensure customers can make informed purchasing choices. The concept of labeling products with the correct country of origin dates all the way back to the McKinley Tariff Act in 1890, and Congress and federal agencies have updated “Made in the USA” rules over the years.

FTC Jurisdiction

The FTC is charged with preventing deception and unfairness in the marketplace. Under the FTC Act, the Commission may bring legal action against “false or misleading claims that a product is of U.S. origin”. The agency is authorized to issue a civil penalty of up to $40,654 per violation.

The FTC has issued guidance on complying with the “Made in the USA” standard, most recently in 2021. View the latest guidance here.

When Can I Say Made in the USA?

For a product to be considered as “Made in the USA” without qualification, that product must be “all or virtually all” made in the U.S. How the Commission determines whether a product is “all or virtually all” made in the U.S. is by looking at whether there was “a ‘reasonable basis’ to support the claim at the time it is made”. To prove […]

By Jennifer Diaz|2026-06-05T11:20:06-04:00June 5, 2026|Best Practices, Enforcement, Import, International Trade, Labeling, U.S. Federal Trade Commission (FTC)|Comments Off

Five Tips for SMEs Looking to Scale Wellness Brands in the US

DTL President Jennifer Diaz was featured in Santander Navigator! Read below or on Santander here.

Pre-planning and investing in regulatory compliance measures are key to success

The US is the most lucrative wellness market in the world – and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore.

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute.

In contrast, China’s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA’s blacklist.

1. Know the regulators

One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says.

Companies also need to designate […]

By Jennifer Diaz|2025-06-17T08:40:04-04:00June 17, 2025|Best Practices, Import, Import Alert, International Business, International Trade, Labeling, Pre-compliance|Comments Off

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|2021-10-01T09:43:08-04:00October 1, 2021|ACE, Best Practices, Counterfeits, CTPAT, Currency Seizure, Customs Broker, Customs Expert, Enforcement, Forced Labor, Freight Forwarding, ICE, Import, International Trade, IPR, Trademarks and Logos, Labeling, Labor Rights, Penalty, Pre-compliance, Reasonable Care, Seizures, U.S. Customs and Border Protection (CBP)|Comments Off

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|2021-09-29T13:28:50-04:00September 29, 2021|Import, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|1 Comment

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|2021-09-07T15:53:46-04:00September 6, 2021|Best Practices, Food, Import, International Trade, Labeling, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off

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|2021-10-07T14:36:07-04:00August 31, 2021|Best Practices, Export, Import, International Trade, Labeling, U.S. Department of Agriculture (USDA)|Comments Off

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|2021-10-07T14:48:15-04:00August 10, 2021|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)|Comments Off

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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By Jennifer Diaz|2021-07-06T09:17:36-04:00July 6, 2021|ACE, Counterfeits, CTPAT, Currency Seizure, Customs Broker, Customs Expert, Enforcement, Forced Labor, Freight Forwarding, ICE, Import, International Trade, IPR, Trademarks and Logos, Labeling, Labor Rights, Penalty, Pre-compliance, Reasonable Care, Seizures, Speaking, U.S. Customs and Border Protection (CBP)|Comments Off

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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By Jennifer Diaz|2021-10-07T14:53:51-04:00May 27, 2021|Best Practices, Food, Import, International Business, International Trade, Labeling, Pre-compliance, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off

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

Whether 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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By Jennifer Diaz|2021-10-07T14:59:28-04:00April 28, 2021|ACE, Best Practices, Counterfeits, CTPAT, Currency Seizure, Customs Broker, Customs Expert, Enforcement, Forced Labor, Freight Forwarding, HTS, ICE, Import, International Business, International Law, International Trade, IPR, Trademarks and Logos, Labeling, Labor Rights, Penalty, Pre-compliance, Reasonable Care, Seizures, Speaking, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Department of Homeland Security (DHS)|Comments Off