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MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). The agency also issued final guidance with recommendations to assist companies and individuals submitting facility registration and product listing information to the FDA.

Cosmetics Direct

The Cosmetics Direct portal is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA. The portal is an FDA Structured Product Labeling (SPL) authoring tool that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing.

Along with the launch of the portal, the agency also released a portal user guide. The guide provides helpful information on creating submissions through the portal including:

Managing accounts and subaccounts
How to check submission information and statuses
Step-by-step instructions for new registrations
Instructions for amending registrations

While the agency prefers electronic submissions, individuals and companies may also submit paper forms which will be offered soon.

Final MoCRA Guidance

The final guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. The guidance document explains several frequently asked questions including:

The statutory requirement to submit cosmetic product facility registrations and product listings
Definitions
Who is responsible for making the submissions
What information to include in the submissions
How to make the submissions
When to make the submissions

The guidance […]

By Jennifer Diaz|2023-12-29T10:44:50-05:00December 29, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products
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FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products
Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)

FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist cosmetics companies submitting cosmetic product listings and cosmetic product facility registrations to the agency. The agency characterized the guidance as playing a critical role in helping to ensure the safety of cosmetic products that many consumers use day-to-day.

Background

The growth in the cosmetics industry over the last several years prompted Congress to pass the Modernization of Cosmetics Regulation Act (MoCRA). in 2022. MoCRA modernizes and strengthens cosmetics regulations in the United States and gives the FDA additional authority. Key MoCRA requirements include:

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. To assist companies in their MoCRA compliance efforts, the FDA has published new guidance answering key questions and providing recommendations.

Draft Guidance

The draft guidance for industry describes MoCRA requirements for facility registration and product listings, as well as the exemptions for certain small businesses. The guidance explains:

The statutory requirement to submit cosmetic product facility registrations and product listings
Definitions
Who is responsible for making the submissions
What information to include in the submissions
How to make the submissions
When to make the submissions

The document also answers key questions such as what to do if a product is both a drug and a cosmetic product and whether there are fees to submit a registration […]

By Jennifer Diaz|2023-08-11T13:47:05-04:00August 11, 2023|Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)|0 Comments

A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

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. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States.

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.

New MoCRA requirements include:

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. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.

Facility Registration and Product Listing

Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.

The FDA may suspend a facility’s registration if the FDA determines […]

By Jennifer Diaz|2024-02-02T14:08:08-05:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|2 Comments

Omnibus Bill: What Changes Can You Expect to Cosmetics Regulation?

On December 22, 2022, U.S. House and Senate leaders passed the long-awaited $1.7 trillion FY2023 omnibus spending bill. This blog provides information on the significant changes to cosmetics regulation with the passage of the Omnibus bill and the Food Drug and Cosmetic Act amendments. We encourage you to contact Diaz Trade Law to assess the implications of the significant changes. […]

By Jennifer Diaz|2023-01-05T15:57:42-05:00January 6, 2023|Best Practices, Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)|0 Comments

Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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