U.S. Food and Drug Administration (FDA) Archives - Page 2 of 41

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

MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings
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MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings
Cosmetics, U.S. Food and Drug Administration (FDA)

MoCRA Update: FDA Provides Summary Data on Facility Registrations and Product Listings

The U.S. Food and Drug Administration (FDA) has released summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background & Requirements

MoCRA was passed in 2022 in an effort to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities.

MoCRA Requirements:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety substantiation
Compliance with Good Manufacturing Practices (GMPs)
Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority.

The FDA has issued guidance providing recommendations to assist companies in complying with the law. In addition, the agency developed a new online tool – Cosmetics Direct – dedicated exclusively to product facility registration and cosmetic product listing submissions.

New Data

As of January 1, 2025, the number of unique, active facility registrations is 9,528 and the number of unique, active product listings is 589,762.

The top five states for number of domestic registered facilities are:

California (373)
Florida (201)
New Jersey (144)
Texas (120)
New York (118)

The top five countries for foreign registered facilities are:

China (4,260)
South Korea (617)
India […]

By Jennifer Diaz|2025-03-26T16:28:22-04:00March 26, 2025|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
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FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
Food, U.S. Food and Drug Administration (FDA)

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

The U.S. Food and Drug Administration (FDA) issued a proposed rule that would require a front-of-package (FOP) nutrition label on most packaged foods.

Rule Details

The label, referred to as the “Nutrition Info Box,” must contain the amounts (per serving) of three nutrients:

Saturated fat
Sodium
Added sugar

The label must also list whether the amount of these ingredients per serving is “Low,” “Med,” or “High.”

The FDA is proposing a compliance date of three years after the final rule’s effective date for businesses with $10 million or more in annual food sales. Businesses with less than $10 million in annual food sales would have four years to comply.

FDA Intent

The FDA stated that the Nutrition Info Box would complement the Nutrition Facts label that is already required on most packaged food. While the Nutrition Facts label is helpful to many consumers, the FDA found that some segments of the population do not regularly read the label.

Therefore, this rule is intended to provide accessible, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy diet.

The agency conducted a literature review that included focus group testing and a peer-reviewed experimental study to explore consumer reactions and responses to various FOP nutrition labels.

The results indicated that interpretive FOP nutrition information is helpful for consumers and easy to understand.

Input on the Rule

The FDA is currently seeking public input on the proposed rule. The deadline to submit comments is May 16, 2025. If you will be impacted by the new requirements, […]

By Jennifer Diaz|2025-01-17T15:57:40-05:00January 17, 2025|Food, U.S. Food and Drug Administration (FDA)|0 Comments

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