Cosmetics Archives - Customs & International Trade Law Firm

FDA Announces One-Day Inspection Pilot
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FDA Announces One-Day Inspection Pilot
Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)

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|2026-05-26T12:37:26-04:00May 26, 2026|Best Practices, Cosmetics, Enforcement, Food, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Update: Increased Cosmetics Oversight Under MoCRA
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FDA Update: Increased Cosmetics Oversight Under MoCRA
Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)

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 cosmetics oversight 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 used daily by consumers.

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. This […]

By Jennifer Diaz|2026-05-08T14:51:49-04:00May 8, 2026|Cosmetics, Enforcement, International Trade, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
Cosmetics, Enforcement, FDA Issues, International Trade, Pre-compliance, U.S. Food and Drug Administration (FDA)

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 Jennifer Diaz|2025-09-19T09:48:31-04:00September 19, 2025|Cosmetics, Enforcement, FDA Issues, International Trade, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

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

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

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