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Reminder: FDA VQIP Applications for FY2027 Close September 1

Short summary: The FDA has announced that the application window for Fiscal Year 2027 Voluntary Qualified Importer Program (VQIP) benefits closes on September 1, 2026. For companies importing FDA-regulated food products, the approaching deadline is a reminder to confirm eligibility, supplier certifications, and application readiness before time runs out.

Deadline and Program Overview

Food importers seeking faster FDA entry processing should take note: the application period for the FDA’s Voluntary Qualified Importer Program (VQIP) for Fiscal Year 2027 closes on September 1, 2026.

VQIP is a fee-based program established under the Food Safety Modernization Act (FSMA) that rewards importers with strong supply chain controls and demonstrated food safety compliance. Approved participants may benefit from expedited review and importation of eligible human and animal food products entering the United States.

Applications approved for FY2027 will provide benefits beginning October 1, 2026, provided the FDA receives both an approved application and the required user fee payment.

Eligibility Requirements 

Importers should not assume they qualify automatically. One of the most common barriers to participation is the requirement that all foreign suppliers associated with VQIP-covered products maintain a valid facility certification issued by an FDA-accredited certification body under the FDA’s Accredited Third-Party Certification Program.

Importers considering VQIP participation should verify:

  • Foreign suppliers hold current certifications from FDA-accredited certification bodies.
  • Required regulatory audits have been completed.
  • Supply chain documentation and food safety controls meet FDA expectations.
  • Internal records are current and ready for submission through the VQIP portal.

Why Importers Should Consider VQIP

For qualifying importers, VQIP can provide meaningful operational advantages, including:

  • Expedited […]
By |2026-08-06T10:10:31-04:00August 6, 2026|U.S. Food and Drug Administration (FDA)|Comments Off on Reminder: FDA VQIP Applications for FY2027 Close September 1
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FDA Proposes New Rule Requiring Foreign Tobacco Manufacturers to Register with the Agency 

Short summary: The FDA has proposed a new rule that would require foreign tobacco product manufacturers to register their establishments and submit product listings to the agency, aligning them with requirements already applicable to domestic manufacturers. While the rule is not yet final, it signals increased oversight of imported tobacco products and enhanced coordination between the FDA and U.S. Customs and Border Protection (CBP).  

On June 26, 2026, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would significantly expand its oversight of imported tobacco products. If finalized, the rule would require foreign tobacco product manufacturers to register their establishments with the FDA and submit product listings. These requirements have long applied to domestic manufacturers but not foreign producers. 

The proposal is intended to close a regulatory gap, strengthen FDA enforcement, and improve the agency’s ability to identify and stop unauthorized tobacco products from entering the United States, particularly e-cigarettes and other youth-appealing products. It also represents another step toward increased scrutiny of imported tobacco products and the companies that manufacture them. 

What Would Change? 

Under the proposed rule, foreign establishments that manufacture, prepare, compound, or process tobacco products for sale in the United States would be required to: 

  • Register their manufacturing establishments with the FDA; 
  • Submit product listings identifying the tobacco products manufactured […]
By |2026-07-07T10:27:14-04:00July 7, 2026|Import, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Proposes New Rule Requiring Foreign Tobacco Manufacturers to Register with the Agency 
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FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years

Topline summary: The FDA has approved bemotrizinol as the first new active sunscreen ingredient in nearly 30 years, creating both an opportunity and a compliance obligation for OTC drug and cosmetic importers. Being permitted to use the ingredient is not the same as being compliant. Manufacturers and importers still need to confirm that their reformulated product meets all conditions of the updated monograph, including SPF testing, Drug Facts labeling, and valid FDA drug establishment registration and drug listing before the goods ship. 

On June 9, 2026, the FDA issued a final order adding bemotrizinol to the OTC sunscreen monograph (M020)—the first new sunscreen active ingredient permitted in the United States in nearly three decades. The ingredient, submitted by DSM Nutritional Products at concentrations up to 6 percent and long marketed in Europe, is now recognized by the FDA as generally recognized as safe and effective (GRASE) for adults and children six months and older.

For manufacturers and importers of sunscreens and other OTC drug and cosmetic products, this is a real opportunity—and a regulated change that touches your formulation, your labeling, your drug establishment registration, and your treatment at the U.S. border. A new permitted active ingredient is not a green light to ship. It is a trigger to confirm your pre-compliance posture before the first entry.

The Challenge: “Permitted” Is Not the Same as “Compliant”

A GRASE listing means bemotrizinol may be used in OTC sunscreens. It does not mean your reformulated product automatically conforms to monograph M020. Sunscreen is regulated by […]

By |2026-06-11T11:06:00-04:00June 11, 2026|U.S. Food and Drug Administration (FDA)|Comments Off on FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years
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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 |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 on FDA Announces One-Day Inspection Pilot
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FDA Update: Increased Cosmetics Oversight Under MoCRA 

The U.S. Food and Drug Administration (FDA) recently published a Voices blog, highlighting the progress the agency has made in implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA Background

MoCRA instituted a sweeping overhaul of federal cosmetics regulation that significantly expanded the FDA’s authority over the cosmetics and personal care industry. The FDA views MoCRA as the most substantial expansion of FDA oversight of cosmetics since the Federal Food, Drug, and Cosmetic Act was enacted in 1938.

MoCRA was signed into law in December 2022 and introduced a broad range of new regulatory requirements aimed at improving consumer safety, increasing transparency, and strengthening FDA enforcement capabilities. The law applies to a wide array of cosmetic products, including makeup, skincare, fragrances, shampoos, and other personal care items that consumers use daily.

Implementation Update

In its recent update, the FDA highlighted several ways the legislation is already reshaping the cosmetics industry. One of the most significant developments is the agency’s increased visibility into cosmetic manufacturing and ingredient use through mandatory facility registration and product listing requirements. The FDA reported:

  • 15,000 unique, active cosmetic product facility registrations
  • Over 1 million unique, active cosmetic product listings.
  • adverse events reported by industry increased by more than threefold

Before MoCRA, the FDA received just 5,176 cosmetic establishment registrations and 35,102 cosmetic product listings through the Voluntary Cosmetic Registration Program. […]

By |2026-05-08T14:52:35-04:00May 8, 2026|Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Update: Increased Cosmetics Oversight Under MoCRA 
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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 |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 on FDA Finalizes New National Drug Code Format
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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 |2026-01-23T07:49:16-05:00January 23, 2026|Food, Gluten Free, news, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Takes Action to Improve Gluten Ingredient Disclosure in Foods
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Potential Government Shutdown on the Horizon and No Contingency Plans in Sight

Government funding will lapse at midnight on Tuesday, September 30, absent Congressional action. With a number of contentious issues still at play, including spending limits, immigration policy, and healthcare funding, some say a shutdown is looking more and more likely.

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, […]

By |2025-09-26T09:30:46-04:00September 26, 2025|Enforcement, U.S. Customs and Border Protection (CBP), U.S. Department of Commerce (DOC), U.S. Department of Homeland Security (DHS), U.S. Department of State (DOS), U.S. Food and Drug Administration (FDA)|Comments Off on Potential Government Shutdown on the Horizon and No Contingency Plans in Sight
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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 |2025-09-19T09:48:33-04:00September 19, 2025|Cosmetics, Enforcement, International Trade, Pre-compliance, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
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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 |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 on ICYMI: FDA Launches Nationalized Entry Review Program (NER)
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