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:

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 Provisional Tobacco Products: that have been withdrawn from the FDA review process.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

MoCRA Facility and Product Registration Portal Now Open! 

Essential deadlines under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) come into effect July 1, 2024. MoCRA brings significant changes to the cosmetic industry and will impact your company if you manufacture, distribute, or pack a cosmetic product in the United States.

What is Required Under MoCRA

MoCRA replaces the previous Cosmetic Act, which had not been updated since 1938.

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.

Registration and Listing Made Easy Through Our Online Portal

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
  • Enlist Diaz Trade Consulting as your U.S. Agent
  • List a cosmetics product
  • Pay registration fees
  • Complete annual renewal
  • Request a UNII code

Get started here. Have questions? Reach out to us at info@diaztradeconsulting.com or call us at 305-400-8458.

Read more about MoCRA:

By |2024-03-15T14:40:32-04:00March 15, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on MoCRA Facility and Product Registration Portal Now Open! 

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 |2023-12-29T10:46:38-05:00December 29, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on MoCRA Update: Final Guidance and Launch of Electronic Submissions Portal

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 […]
By |2023-05-24T12:27:23-04:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|Comments Off on A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act

FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations  

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA officially began enforcement on January 1, 2023 but gave a 60-day grace period before beginning to verify numbers.

What is a DUNS Number?

DUNS stands for Data Universal Numbering System. It is a proprietary system developed by Dun & Bradstreet (D&B) that assigns a unique number to a business entity that is recognized worldwide. The DUNS system is not unique to the FDA. Other DUNS users include the UN, Apple, and the European Commission.

Why is the FDA Requiring This Now?

The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. The DUNS requirement dates back to 2016 when the agency issued a rule implementing new food facility registration requirements. Under the rule, the FDA requires facilities to provide a unique facility identifier (UFI) when registering. Subsequent guidance provided that a DUNS number is an acceptable UFI for registration.

The utilization of DUNS numbers will help the FDA:

  • Improve accuracy and consistency in the registration database
  • Identify facilities that pose a risk
  • Verify the authenticity of registrations
  • Ensure that facility information is up to date

The FDA has been working with facilities who have had difficulty obtaining a DUNS number and has issued guidance allowing registrants to enter a “PENDING” status if they cannot obtain a number in time.

What Do Food Facilities Need to Do?

Food facilities that […]

By |2023-04-27T21:51:35-04:00April 27, 2023|Food, U.S. Food and Drug Administration (FDA)|Comments Off on FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations  

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 |2023-01-06T11:31:44-05:00January 6, 2023|Best Practices, Cosmetics, Import, International Trade, U.S. Food and Drug Administration (FDA)|Comments Off on Omnibus Bill: What Changes Can You Expect to Cosmetics Regulation?

Customs and Trade Law Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

 

 

 

 

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Customs and Trade Law Weekly Snapshot

Here is a recap of the latest customs and international trade law news:

 

 

 

 

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