Food Archives | Customs & International Trade Law Blog

FDA Announces One-Day Inspection Pilot

The U.S. Food and Drug Administration (FDA) announced that it is piloting one-day inspectional assessments. These assessments will be shorter, more focused, and will complement existing standard FDA inspections.

Shorter Inspections, More Coverage

Launched in April 2026, the pilot is part of a broader initiative to make the agency’s inspectional resources more targeted and efficient. The new assessments will allow for broader coverage, enabling the agency to assess more facilities without compromising regulatory rigor.

The pilot is being conducted across multiple FDA inspectorates, including human and animal foods, biologics, medical products, and clinical research programs. Facilities are selected using risk-based criteria such as:

Product type
Prior inspection outcomes
Operational characteristics

As of late April 2026, the FDA has completed approximately 46 one-day assessments.

The agency made clear that one-day inspectional assessments are not intended to replace standard FDA inspections. Instead, they are meant to provide an additional tool to the agency’s enforcement approach. The ‘one-day’ framework is also flexible – investigators retain authority to expand the scope or duration of an assessment if warranted.

The pilot will continue through fiscal year 2026. The FDA is currently developing evaluation metrics to assess effectiveness, including inspection duration, escalation rates, and the utility of findings in informing risk-based decision-making.

What Facility Owners and Operators Should Do

Facility owners and operators should remain ready […]

By Jennifer Diaz|2026-05-26T12:37:23-04:00May 26, 2026|Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Finalizes New National Drug Code Format

On March 5, 2026, the Food and Drug Administration (FDA) published a Final Rule adopting a new format for the National Drug Code (NDC). The rule takes effect on March 7, 2033. On the effective date, the FDA will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs to the uniform 12-digit NDC format.

What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

4-4-2
5-3-2
5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- […]

By Jennifer Diaz|2026-03-05T10:07:19-05:00March 5, 2026|Enforcement, Food, Import, Medical Devices, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Takes Action to Improve Gluten Ingredient Disclosure in Foods

On January 22, 2026, the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food.

Background

The FDA received a citizen petition requesting that the FDA act to protect consumers with celiac disease by better enabling them to identify, through labeling, whether a food includes gluten-containing grains (GCGs), and to address cross-contact with GCGs. FDA subsequently reviewed available data and reports, which indicated that serious data gaps are limiting the agency’s ability to fully evaluate the public health importance of these ingredients, including data on adverse reactions.

Request for Information

The FDA is taking this action as a first step to improve transparency in disclosures of ingredients that impact certain health conditions, such as gluten for those with celiac disease, and other established food allergens.

The agency is inviting comments concerning adverse reactions due to “ingredients of interest” ( i.e., non-wheat GCGs and oats) in the United States. The RFI also aims to collect data on labeling issues or concerns with identifying ingredients of interest on packaged food products in the United States.

The FDA is particularly interested in:

Data and information on IgE-mediated and non-IgE-mediated food allergies and adverse reactions to non-wheat GCGs (including prevalence, severity, and potency).
Data and information on gluten in oats (including frequency and amounts of gluten in […]

By Jennifer Diaz|2026-01-23T07:49:16-05:00January 23, 2026|Food, Gluten Free, news, U.S. Food and Drug Administration (FDA)|Comments Off

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|2025-09-12T09:42:51-04:00September 12, 2025|Cosmetics, Enforcement, Food, Import, International Trade, Medical Devices, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off

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|2025-07-17T09:41:31-04:00July 17, 2025|Enforcement, Food, Import, International Trade, Supply Chain, U.S. Department of Agriculture (USDA), U.S. Department of Homeland Security (DHS), U.S. Department of Justice (DOJ)|Comments Off

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|2025-01-17T16:00:51-05:00January 17, 2025|CBD, China Trade War, Customs Expert, Enforcement, Food, ICE, Reasonable Care, Supply Chain, U.S. Federal Trade Commission (FTC), U.S. Food and Drug Administration (FDA)|Comments Off

FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling

On December 19, 2024, the FDA announced a final rule to update the criteria that food must meet to qualify for use of the claim “healthy”.

New Requirements

To meet the updated criteria, a food product needs to:

Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
Meet specific limits for added sugars, saturated fat and sodium.

The criteria vary for individual food products.

Under the new rule, nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients automatically qualify for the “healthy” claim. These include:

Vegetables
Fruits
Whole grains
Fat-free and low-fat dairy
Lean game meat
Seafood
Eggs
Beans
Peas
Lentils
Nuts
Seeds

Products that do not qualify for the healthy label under the updated rule include:

Fortified white bread
Highly sweetened yogurt
Highly sweetened cereal

These changes reflect current nutrition science and dietary guidance in the Dietary Guidelines for Americans.

What Food Manufacturers Should Do

The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a “healthy” label meets the new criteria. Diaz Trade Law has subject matter FDA expertise and can help you with a proactive compliance plan that meets the new requirements.

FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA officially began enforcement on January 1, 2023 but gave a 60-day grace period before beginning to verify numbers.

What is a DUNS Number?

DUNS stands for Data Universal Numbering System. It is a proprietary system developed by Dun & Bradstreet (D&B) that assigns a unique number to a business entity that is recognized worldwide. The DUNS system is not unique to the FDA. Other DUNS users include the UN, Apple, and the European Commission.

Why is the FDA Requiring This Now?

The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. The DUNS requirement dates back to 2016 when the agency issued a rule implementing new food facility registration requirements. Under the rule, the FDA requires facilities to provide a unique facility identifier (UFI) when registering. Subsequent guidance provided that a DUNS number is an acceptable UFI for registration.

The utilization of DUNS numbers will help the FDA:

Improve accuracy and consistency in the registration database
Identify facilities that pose a risk
Verify the authenticity of registrations
Ensure that facility information is up to date

The FDA has been working with facilities who have had difficulty obtaining a DUNS number and has issued guidance allowing registrants to enter a “PENDING” status if they cannot obtain a number in time.

What Do Food Facilities Need to Do?

Food facilities that […]

By Jennifer Diaz|2023-04-27T21:51:35-04:00April 27, 2023|Food, U.S. Food and Drug Administration (FDA)|Comments Off

USDA Proposes New “Made in the USA” Standard

U.S. consumers who seek animal food products labeled as “Made in the USA,” or who simply value transparency on food product labels, may finally catch a break. On March 6, 2023, the USDA released a proposed rule to help define what is meant when a food product is a “Product of USA” or “Made in the USA.” Currently, Food Safety and Inspection Service (FSIS) regulated products may be labeled as “Product of USA” even when an animal product is derived “from animals that may have been born, raised, and slaughtered in another country but are minimally processed in the United States.”

As a result of the U.S. President’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the proposed rule allows a “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.

Albeit, a very significant caveat accompanies the proposed rule, which is, that, labeling a food product in accordance with the latter is completely voluntary. The U.S. Federal Trade Commission (FTC) takes a similar course of action. While the FTC regulates U.S. origin claims under its authority to act against deceptive acts and practices, foreign-origin markings on products are regulated primarily by U.S. Customs under the Tariff Act of 1930. The similarity in the rules is that neither Customs nor the FTC requires that goods made […]