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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

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.

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

Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System
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Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System
U.S. Food and Drug Administration (FDA)

Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System

As of October 1, 2024, listing of over-the-counter (OTC) monograph drug products will not be able to be certified under the old marketing categories and old application number fields in FDA’s Electronic Drug Registration and Listing System (eDRLS). Instead, the listing of such products will need to include the current Marketing Category and Application Number values.

New Certification Requirements Background

The FDA utilizes the eDRLS for several key programs including drug quality reports, adverse event reports, and drug import and export compliance.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The law amended the Federal Food, Drug and Cosmetic Act (FD&C Act) and modernized the OTC drug review process.

The amendments required the FDA to update the marketing category and application number fields for OTC monograph drugs in the eDRLS.

eDRLS Field Updates

The change in current values to be used effective October 1st, 2024, are:

For the marketing category field, the categories “OTC monograph final” and “OTC monograph not final” are permanently replaced with the single term “OTC monograph drug,” to be used for nonprescription drug products marketed without an approved new drug application.
For the application number field, the use of OTC monograph CFR parts was discontinued starting October 2023 and the old submissions referencing the CFR parts must now be updated to include the appropriate Monograph ID.

As of October 1, 2024, drug listing records that refer to the old marketing categories and CFR parts citations will no longer be available for certification.

OTC drug […]

By Jennifer Diaz|2024-10-18T12:26:55-04:00October 18, 2024|U.S. Food and Drug Administration (FDA)|0 Comments

MoCRA Enforcement is Right Around the Corner! Are You Ready?

The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action.

MoCRA Background

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety.

MoCRA was passed in 2022 and aims 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 brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing.

MoCRA Requirements

New MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety […]

By Jennifer Diaz|2024-06-11T09:59:49-04:00June 11, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Unveils Searchable Tobacco Products Database to Bolster Compliance and Transparency
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FDA Unveils Searchable Tobacco Products Database to Bolster Compliance and Transparency
Tobacco, U.S. Food and Drug Administration (FDA)

FDA Unveils Searchable Tobacco Products Database to Bolster Compliance and Transparency

Last week, FDA’s Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database. This tool provides easy access to a list of legally marketable tobacco products within the United States, integrating a user-friendly design with sophisticated search functionalities, making navigation and information retrieval very easy. The FDA has committed to monthly updates, ensuring the availability of current and accurate product information.

FDA categorizes listed tobacco products into three groups:

New Tobacco Products: products that have successfully navigated through one of the FDA’s pathways for new tobacco product market authorization.
Pre-existing Tobacco Products: Identified through a voluntary determination program, these products were commercially available as of February 15, 2007.
Provisional Tobacco Products: that have been withdrawn from the FDA review process.

The database fosters enhanced transparency that aligns with the needs particularly of retailers, to empower stakeholders to better meet regulatory requirements. It encompasses nearly 17,000 tobacco products, including more than 12,000 Pre-existing Tobacco Products category. The database provides detailed information for each listed product, including the product name, manufacturer, categorization, the statutory or regulatory basis for its marketability in the U.S., and the specific date of the FDA’s decision. It also provides access to an array of regulatory and scientific documents associated with the tobacco product application, including Order Letters, Decision Summaries, Environmental Assessments (EAs), and their related documentation.

FDA has also introduced a supplementary resource, the Searchable Tobacco Products Database – Additional Information, designed to demystify the terminology and contextual background of the database […]

By Jennifer Diaz|2024-04-02T16:37:01-04:00April 2, 2024|Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

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