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!!!!

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 best practices for consolidated proceedings for appeals. 

Rather than amend the existing FDR guidance to include FDR procedures for Final Orders and issue a separate guidance for consolidated proceedings for appeals, the FDA is issuing this single guidance to address both issues. 

This guidance finalizes the earlier draft guidance published in June 2023. The FDA considered comments received on that draft during its guidance finalization process. 

Updated Guidance 

This guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the CDER and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the FD&C Act. 

The drugs that this guidance covers are nonprescription drugs without approved new drug applications, which are subject to section 505G. 

The guidance addresses:

• CDER’s FDR procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a Final Order. 
• The procedures for an administrative hearing related to a Final Order. 
• The procedures for consolidated proceedings for FDR and hearings to resolve scientific and/or medical disputes related to Final Orders.

Reminder: FDA’s guidance documents do not establish legally enforceable responsibilities. Guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 

Affected parties can submit online or written comments on any guidance at any time.

For assistance in understanding how this guidance impacts your business, contact Diaz Trade Law at 305-456-3830 or info@diaztradelaw.com.

Learn more:

• 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

What makes this potential shutdown different from previous lapses in funding is the lack of contingency plans within the relevant agencies. The White House’s Agency Contingency Plan page is blank. 

Until agencies update their guidance, we can only look to previous contingency plans.

Below is a breakdown of previously issued agency guidance. ,

U.S. Customs and Border Protection

According to the Department of Homeland Security’s most recent contingency plan (March 2025) cargo inspection functions at ports of entry will remain active during a shutdown. However, certain activities, such as training and auditing, are not required to be carried out during this time. In addition, back-office support positions are not likely to be deemed essential and will be furloughed. Refunds, audits, ruling requests, etc., would be delayed until the shutdown ends.

There remains uncertainty around which specific offices will be deemed essential. For example, Forced Labor Communications may be furloughed, resulting in delays in reviewing the Enforce and Protect Act (EAPA) and Uyghur Forced Labor Prevention Act (UFLPA) allegations.

U.S. Department of Commerce

According to the Department of Commerce’s most recent contingency plan (September 2023), some International Trade Administration (ITA) activities, such as trade policy negotiations, will be considered necessary for national security and will operate during a shutdown. However, many other activities are not likely to be deemed essential. For example, in the last shutdown in 2019, the ITA and the Bureau of Industry and Security operated with a significantly reduced staff and budget. All antidumping and countervailing duty (AD/CVD) investigations and administrative proceedings will stop.

U.S. Department of State

According to the department’s most recent contingency plan (August 2023), many administrative functions will be subject to furloughs, which will result in a delay in licensing and other regulatory functions.

Food and Drug Administration (FDA)

Unlike many other agencies that are funded solely by government appropriations, the majority of FDA staff is funded by other revenue (agency fees) and is therefore exempt from a government shutdown. According to the agency’s most recent contingency plan (December 2023), 77% of FDA staff will be retained in the event of a lapse of appropriation. Entry reviews and exams will continue, as well as high-risk investigations. However, importers should expect delays in the processing of import transactions.

While many agencies and employees critical to international trade will not be subject to furloughs during a shutdown, companies should still expect delays and disruptions. Diaz Trade Law will continue to monitor developments and provide updates when they become available.

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. 

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with cosmetics compliance requirements, required registration, reporting, 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

• 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

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 a US agent to act on their behalf before shipments begin.

“Most entities also don’t realize that the US has 47 regulatory agencies that can regulate imports and exports, so you may be dealing with multiple federal regulatory agencies that regulate your product,” she adds.

For example, the FDA, Federal Trade Commission (FTC) and US Customs regulate the imported supplements market, she says.

2. Beware of being blacklisted

One underestimated risk for SMEs launching their supplements in the US is the FDA’s import alert system, which Diaz describes as a blacklist for companies that have failed to comply with regulations.

This could be anything from mislabeling products to not using English on labels, making false medical claims, or failing to register with the FDA, Diaz explains, adding that it is time-consuming and costly to be removed from the list.

“Many SMEs don’t have the ability to survive the enforcement because the full weight of the government on you when you’re non-compliant is big,” she says.

“The government does not have the resources to hold your hand and help you when it comes to compliance – the expectation is that the product is already compliant and you’re smart enough to pick the right business partners and agents before you launch.”

3. Be wary of influencers

Marketing claims, even those from third parties such as influencers, also fall under FDA and FTC regulations, according to Diaz.

“What many don’t realize is that the FDA can legally make your life miserable over your marketing claims, in addition to what’s on your product,” Diaz says.

For example, suppose a business sends a supplement to an influencer to promote it on social media and they claim that it cured their cancer. In this case, the company is deemed liable if they don’t “de-escalate” the claim, Diaz explains.

“The FDA has the legal ability to issue a company a warning letter for the claims that they make on their website or for the claims that influencers make on their behalf on social media.”

4. Set a budget for compliance

Not spending the time or money on pre-compliance preparation can also lead to costly errors, says Diaz.

“It could be hundreds of thousands of dollars if your goods are seized or you receive an FDA audit or warning letter,” she says.

Diaz recommends that SMEs conduct independent testing in a laboratory to verify ingredient claims, as well as taking out product liability insurance to protect against litigation and organizing a legal review of all labels, ingredients and marketing content.

5. Protect your brand

Diaz also recommends that SMEs protect their brands by registering them with the US Patent and Trademark Office.

“Once you register your trademark, you should also record it with US Customs and then teach them how to spot copies of your brand, such as unique packaging,” Diaz says. 

“Customs then logs it in its secret database and it goes to all customs officers – there are 60,000 customs officers in the country at 328 ports of entry – and they will fine the offender and alert you if they spot a fake.”

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 (309)
• Italy (273)
• France (245)

Are You MoCRA Compliant?

The MoCRA compliance deadline was July 1, 2024.

Companies behind on registration should immediately establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping.

Not sure what is required to register a facility or list a cosmetic product? Our online portal will take you through the process step-by-step to ensure you are in compliance.

On our website you can:

• Register a facility
• Assign Diaz Trade Consulting as your U.S. Agent (it is mandatory for foreign facilities to have a U.S. Agent)
• List a cosmetics product
• Pay registration fees
• Complete annual renewal
• Request a UNII code

Visit the portal today or contact us to learn more about MoCRA requirements – info@diaztradelaw.com.

Learn more:

• Blog: A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• Blog: MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal
• Webinar: Getting MoCRA Compliant

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