FDA Issues Archives - Page 2 of 32 - Customs & International Trade Law Firm

ICYMI: FDA Issues Final Guidance On Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs
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ICYMI: FDA Issues Final Guidance On Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs
FDA Issues, news, U.S. Food and Drug Administration (FDA)

ICYMI: FDA Issues Final Guidance On Formal Dispute and Administrative Hearings of Final Orders for OTC Monograph Drugs

On December 23, 2025, the Food and Drug Administration (FDA) published a Federal Registerthe notice announcing the availability of a final guidance for industry entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.”

This guidance provides recommendations on the formal dispute resolution (FDR) and administrative hearings procedures for resolving disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Background

Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in March 2020. After the FDA issues a Final Order in accordance with section 505G(b)(2) of the FD&C Act, the FDA must afford eligible requestors or sponsors the opportunity for FDR and hearings on disputes over the Final Order.

The FDA previously agreed to specific performance goals and procedures described in a commitment letter (read here). The commitment letter specified that the agency would revise previous guidance for industry to include circumstances and procedures under which FDR may be used with respect to Final Orders under section 505G of the FD&C Act. The letter also stated that the agency would issue guidance on its views regarding […]

By Jennifer Diaz|2026-01-07T09:37:49-05:00January 7, 2026|FDA Issues, news, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
Cosmetics, Enforcement, FDA Issues, International Trade, Pre-compliance, U.S. Food and Drug Administration (FDA)

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

On September 12, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. The system is an interactive tool designed to facilitate the public’s ability to search and find real-time adverse event data on cosmetic products. Through the tool, users can search and view reports using search terms, including the product name. Users can also download data sets and report listings. The FDA will update the tool daily to ensure it includes the most recent submissions.

The dashboard includes serious adverse event reports submitted by responsible persons for cosmetic products under requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as well as voluntary adverse event reports submitted to the FDA by healthcare professionals, consumers, salon professionals, cosmetologists, and others.

This announcement follows a recent launch of real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.

In the announcement, the FDA stated these real-time reporting tools are part of the agency’s commitment to transparency and providing greater insight into the safety and regulation of the products consumers use every day.

Note: Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event.

By Jennifer Diaz|2025-09-19T09:48:31-04:00September 19, 2025|Cosmetics, Enforcement, FDA Issues, International Trade, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

ICYMI: FDA Launches Nationalized Entry Review Program (NER)
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ICYMI: FDA Launches Nationalized Entry Review Program (NER)
Cosmetics, Enforcement, Food, Import, International Trade, Medical Devices, Pre-compliance, U.S. Food and Drug Administration (FDA)

ICYMI: FDA Launches Nationalized Entry Review Program (NER)

FDA recently implemented the Nationalized Entry Review Program (NER), which centralizes how the agency reviews imports nationwide. The program is effective as of August 4, 2025. Key changes include:

Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.
Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.
Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.
Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network.

The FDA’s current evaluative standards, regulatory requirements, and admissibility thresholds remain the same.

The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with NER requirements or other FDA matters, contact us […]

By Jennifer Diaz|2025-09-12T09:41:36-04:00September 12, 2025|Cosmetics, Enforcement, Food, Import, International Trade, Medical Devices, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

ICYMI: USDA Plan Calls for Stronger Enforcement of Agricultural Imports
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ICYMI: USDA Plan Calls for Stronger Enforcement of Agricultural Imports
Enforcement, Food, Import, International Trade, Supply Chain, U.S Department of Homeland Security (DHS), U.S. Department of Agriculture (USDA), U.S. Department of Justice (DOJ)

ICYMI: USDA Plan Calls for Stronger Enforcement of Agricultural Imports

On July 8, 2025, the U.S. Department of Agriculture (USDA), along with the Department of Homeland Security (DHS), the Department of Justice (DoJ), and the Department of Defense (DoD), released a National Farm Security Action Plan to elevate American agriculture as a key element of the country’s national security.

Plan Details

The action plan will enable USDA to work closely with governors, state legislators, and federal partners to further integrate agriculture into the broader national security efforts over the coming months and years.

The USDA and its government partners will take “aggressive action” across seven critical areas:

Secure and Protect American Farmland – Address U.S. foreign farmland ownership from adversaries head-on. Total transparency. Tougher penalties.
Enhance Agricultural Supply Chain Resilience – Refocus domestic investment into key manufacturing sectors and identify non-adversarial partners to work with when domestic production is not available. Plan for contingencies.
Protect U.S. Nutrition Safety Net from Fraud and Foreign Exploitation – Billions have been stolen by foreign crime rings. That ends now.
Defend Agricultural Research and Innovation – No more sweetheart deals or secret pacts with hostile nations. American ideas stay in America.
Put America First in Every USDA Program – From farm loans to food safety, every program will reflect the America […]

By Jennifer Diaz|2025-07-17T09:41:22-04:00July 17, 2025|Enforcement, Food, Import, International Trade, Supply Chain, U.S Department of Homeland Security (DHS), U.S. Department of Agriculture (USDA), U.S. Department of Justice (DOJ)|0 Comments

Five Tips for SMEs Looking to Scale Wellness Brands in the US
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Five Tips for SMEs Looking to Scale Wellness Brands in the US
Best Practices, Import Alert, International Business, International Trade, Labeling, Pre-compliance

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|2025-06-17T08:01:40-04:00June 17, 2025|Best Practices, Import Alert, International Business, International Trade, Labeling, Pre-compliance|0 Comments

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