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:

 

 

 

 

[…]

Customs and Trade Law Weekly Snapshot

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

 

 

 

 

[…]

Customs and Trade Weekly Snapshot

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

 

 

 

 

 

United States Department of Commerce (DOC)

  • The U.S. Department of Commerce (DOC) determines that carbon and alloy steel threaded rod (steel threaded rod) from India is not being sold in the United States at below normal value.  
  •  As a result of the respective determinations by the DOC and the U.S. International Trade Commission (ITC) that termination of the 2016 Agreement Suspending the Antidumping Duty Investigation on Lemon Juice from Argentina (2016 Agreement) and the underlying antidumping duty investigation on lemon juice from Argentina would likely lead to continuation or recurrence of dumping 
  • The DOC preliminarily finds that Hangzhou Ailong Metal Products Co., Ltd. (Ailong) made sales of subject merchandise at prices below normal value (NV) 
  • On July 29, 2022, the DOC published the preliminary results of the changed circumstances review (CCR) of the antidumping duty (AD) order on multilayered wood flooring (MLWF) from the People’s Republic of China (China). 
  • The DOC published a notice in the Federal Register on August 2, 2022, for the preliminary results and partial recission of the 2020–2021 administrative review of the antidumping duty order on certain pasta (pasta) from Italy 
  • The DOC preliminarily finds […]
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