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- digits and 2 in 11-digits. There may be confusion between an FDA-assigned 11-digit NDC and a HIPAA converted 11-digit NDC.

The New NDC Standard

The Final Rule modifies existing regulations to establish a uniform, 12-digit format that can accommodate longer NDCs once the FDA begins issuing 6-digit labeler codes.

The change will impact a variety of industries and stakeholders, including:

• Human and animal drug manufacturers and distributors
• Drug importers
• Federal agencies using the NDC
• Drug databanks
• Pharmacies
• Hospitals, clinics, labs, healthcare practitioners
• Nursing care facilities
• Electronic health record vendors
• State and local governments
• Various supply chain stakeholders

The rule change standardizes the NDC format across all sectors and minimizes confusion and medication errors.

During the seven years before the rule takes effect (March 5, 2026 – March 6, 2033), the FDA will continue to assign 10-digit NDCs in the current formats. Manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors, and other supply chain partners should use this time to update their systems, processes, and infrastructure to handle the 12-digit NDC format by March 7, 2033.

Diaz Trade Law will continue to monitor developments concerning this proposed rule. We provide guidance on a variety of FDA matters, including food, cosmetics, drugs, alcohol, medical devices, and more.

Learn more about FDA compliance:

• Webinar: Tips on FDA’s Medical Device Registration Process
• FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations
• Webinar: Importing Medical Devices in Compliance with U.S. FDA
• Webinar: FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Detentions, Warning Letters, and Import Alerts: How to Use FDA’s Databases to Perform Due Diligence
• Webinar: Getting MoCRA Compliant

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 oats), and the prevalence, severity, and potency of IgE-mediated and non-IgE-mediated allergy and adverse reactions to oats.
• Data and information on undisclosed ingredients of interest (including their prevalence and usage amounts in food products and adverse events resulting from consumption of these food products).
• Data and information related to ingredients of interest, including potential consumer perspectives and experiences.

Interested parties may submit information through the regulations.gov electronic filing system or by mail through March 23, 2026.

Learn more:

• Webinar: FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• ICYMI: FDA Launches Nationalized Entry Review Program (NER)
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
• FDA Helps Small Businesses Get Ready for New “Gluten-Free” Labeling Requirements
• FDA Finally Issues Definition of “GLUTEN FREE”!
• Gluten Free Labeling is Coming – But, First, FDA Wants to Hear From YOU!!!!

• 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 at 305-456-3830 or info@diaztradelaw.com.

Learn more:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

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:

1. Secure and Protect American Farmland – Address U.S. foreign farmland ownership from adversaries head-on. Total transparency. Tougher penalties.
2. 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.
3. Protect U.S. Nutrition Safety Net from Fraud and Foreign Exploitation – Billions have been stolen by foreign crime rings. That ends now.
4. Defend Agricultural Research and Innovation – No more sweetheart deals or secret pacts with hostile nations. American ideas stay in America.
5. Put America First in Every USDA Program – From farm loans to food safety, every program will reflect the America First agenda.
6. Safeguard Plant and Animal Health – Crack down on bio-threats before they ever reach our soil.
7. Protect Critical Infrastructure – Farms, food, and supply chains are national security assets and will be treated as such.

The action plan is the next pillar of the USDA “Make Agriculture Great Again” initiative and seeks to protect the country’s agricultural supply chains from security vulnerabilities. 

Increased Enforcement

Notably, the plan also states that the federal government is looking to increase enforcement on “logistics providers, customs brokers, and other trade intermediaries” that are responsible for importing “dangerous biochemicals and biological agents.” 

According to the plan, the USDA intends to review and modernize import restrictions to prevent the spread of dangerous chemicals and agents. USDA will work with federal partners, including CBP, “to strengthen our nation’s borders against entry of restricted goods that could carry animal disease, plant pests, and biological pathogens that can be weaponized against the American public.”

Response and Next Steps

Several members of Congress, governors, and state Agricultural Secretaries issued statements praising the plan, calling it critical to the agricultural economy and to the national security of the United States.

The action plan contains a lengthy list of action items for USDA to take, including an assessment of security risks in the agriculture infrastructure sector, modernizing import restrictions, and eliminating support programs to countries of concern.

Diaz Trade Law will continue to monitor developments as the USDA implements the plan.  

Read more:

• ICYMI: President Trump Signs America First Trade Policy
• USDA Proposes New “Made in the USA” Standard
• USDA Trade Matters

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, make your voice heard by filing a comment! Diaz Trade Law can help you draft and file a comment and/or help you understand how this rule may impact your business.

Read more:

• Webinar: Importing Food in Compliance With U.S. FDA and Surviving A FSVP Audit
• FDA Pre-Compliance and Enforcement
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• Bioengineered Food Labeling

New Requirements

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

1. 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
2. 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.

Read more:

• Updated “Healthy” Claim Factsheet
• Webinar: Importing Food in Compliance With U.S. FDA and Surviving A FSVP Audit
• FDA Pre-Compliance and Enforcement

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 partially or wholly in the U.S. be labeled with “Made in USA” or allude to any other indication of U.S. origin (but, if companies do choose to utilize the claim, the company must be prepared to defend it and ensure it uses it correctly). The exception to this is for textile, wool, and fur products as processing or manufacturing occurring in the U.S. must be disclosed.

In the context of the USDA, such labeling would also remain eligible for generic label approval, eliminating the need to be pre-approved by FSIS before it could be used on regulated products, and incorporates laxed auditing standards for supporting documentation.

Another effect of the proposed rule is forecasted to positively impact those involved with animal husbandry for commercial purposes.  The USDA’s proposed rule bolsters the Packers and Stockyards Act (P&S) of 1921 ‘“to safeguard farmers and ranchers… to protect consumers… and to protect members of the livestock, meat, and poultry industries from unfair, deceptive, unjustly discriminatory and monopolistic practices”’ This is reassuring when taking into account that:

• The global beef market is projected to grow from $414.98 billion to $604.34 billion by 2029, at a Compound Annual Growth Rate (CAGR) of 5.52% in forecast period, 2022-2029;
• The global poultry market is expected to grow at a CAGR of 7.2% to nearly $465.7 billion by 2025, and at a CAGR of 6.8% to $645.7 billion by 2030; and that,
• The global egg market is expected to grow annually by 7.70% (CAGR 2023-2027).

The USDA encourages stakeholders to publicly comment on the proposed rule for the 60-day window after publication of the same at www.regulations.gov. If you have questions or want to make your voice heard, contact info@diaztradelaw.com to discuss how Diaz Trade Law can assist you.

Mexico 

• On February 13, 2022, the United States has suspended all imports of Mexican avocados until further notice after a U.S. plant safety inspector in Mexico received a threatening message on his official cellphone.

OFAC

• On February 11, 2022, The Department of Treasury’s Office of Foreign Assets Control (OFAC) removed from the Code of Federal Regulations the Burundi Sanctions Regulations because of the termination of the national emergency that the regulations were based on. The Burundi Sanction Regulations were originally issued in 2016 to provide immediate guidance to the public.
• On February 15, 2022, The Department of the Treasury’s Office of Foreign Assets Control (OFAC) added regulations to implement a November 12, 2020 Executive order related to securities investments that finance Communist Chinese military companies, as amended by a June 3, 2021 Executive order related to the Chinese military-industrial complex and Chinese surveillance technology. These regulations will take effect on February 16, 2022 in addition to OFAC’s amendment to the Weapons of Mass Destruction Proliferators Sanctions Regulations, 31 CFR part 544 that revises an existing general license authorizing the provision of certain legal services and adds a general license authorizing payments for legal services from funds originating outside the United States.

If you have questions about these updates, contact our Customs and International trade law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

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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.

Why Should I Register for this Webinar?
The FDA is actively enforcing its laws and regulations against non-compliant food importers, as seen by the 92 warning letters issued to food importers.  Importers of food are required to develop, maintain, and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Food importers must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions as FSVP is a top priority for the agency.  FDA’s most common enforcement activities include notices of FDA action, warning letters, import alerts, seizures, voluntary recalls, injunctions, and criminal prosecution.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, Importing Food in Compliance with U.S. FDA and Surviving A FSVP Audit to train industry on top compliance tips to avoid enforcement, best practices in responding to various FDA enforcement, and tools to survive a FSVP audit.

Warning Letters issued in FY21:

• With Fy21 yet to finish, the FDA is likely to continue issuing more warning letters for FSVP violations (currently 92) than it had issued in all of FY20 (50). Each firm that received a warning letter was under a Foreign Supplier Verification Programs (FSVP) audit when the violations were identified.

Recalled Food and Cosmetic Products in 2021:

• Since 2012 there have been a total of 21,451 food/cosmetic products recalled!  
• There are a total of 918 ongoing food/cosmetic product recalls being performed by 255 companies. Don’t be one of them!

In this webinar, you will receive an overview of the Food Safety Modernization Act (FSMA). Presenters will discuss the requirements of the FSMA FSVP rule and its implications on US food importers and foreign suppliers. The objective of the webinar is to teach participants how to navigate FDA’s regulatory framework as well as to provide top tips for how to develop a FSVP plan and how to pass a FSVP Audit.

Suppliers, importers, distributors, and others engaged in the production or sale of imported food are encouraged to attend either live on September 8, 2021 at 12:00 PM, or on demand thereafter. Register Here.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!