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U.S. Food and Drug Administration (FDA)

Call 305-456-3830 or email info@diaztradelaw.com.

Join Diaz Trade Law at Americas Food and Beverage Show!

Americas Food and Beverage Show is one of the largest food and beverage shows with over 5,000 buyers representing Africa, Asia, Australia, the Caribbean, Central America, Europe, Middle East, North America, and South America. The show also has a conference tied to it where leading experts will provide market trends, FDA compliance tips, trends, challenges and opportunities in the food sector, and much more. Diaz Trade Law is excited to announce that our President, Jennifer Diaz, will be a featured speaker discussing “Top 10 Tips When Importing into the U.S. in compliance with CBP and FDA.”The food show and conference are happening September 18th – 20th, 2023 from 8:00 a.m. to 5:00 p.m. EST and will take place at the Miami Beach Convention Center, 1901 Convention Center Dr., Miami Beach, FL 33139.

Why Attend?

  • Over 600 Exhibitors
  • Food and Beverage Demo Stage
  • 245,000 sq. ft. of exhibition space
  • Buyers from more than 50 countries
  • Annual conference with industry experts including our very own Jen Diaz!

Register as a buyer or attendee HERE!

 

By |2023-09-14T09:48:27-04:00September 14, 2023|Events, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments
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FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist cosmetics companies submitting cosmetic product listings and cosmetic product facility registrations to the agency.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 |2023-08-11T13:47:05-04:00August 11, 2023|Cosmetics, FDA Issues, U.S. Food and Drug Administration (FDA)|0 Comments
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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 […]
By |2023-05-24T12:34:26-04:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|2 Comments
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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 |2023-04-27T21:58:55-04:00April 27, 2023|U.S. Food and Drug Administration (FDA)|0 Comments
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USDA Proposes New “Made in the USA” Standard

U.S. consumers who seek animal food products labeled as “Made in the USA,” or who simply value transparency on food product labels, may finally catch a break. On March 6, 2023, the USDA released a proposed rule to help define what is meant when a food product is a “Product of USA” or “Made in the USA.”  Currently, Food Safety and Inspection Service (FSIS) regulated products may be labeled as “Product of USA” even when an animal product is derived “from animals that may have been born, raised, and slaughtered in another country but are minimally processed in the United States.”

As a result of the U.S. President’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the proposed rule allows a “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.

Albeit, a very significant caveat accompanies the proposed rule, which is, that, labeling a food product in accordance with the latter is completely voluntary. The U.S. Federal Trade Commission (FTC) takes a similar course of action. While the FTC regulates U.S. origin claims under its authority to act against deceptive acts and practices, foreign-origin markings on products are regulated primarily by U.S. Customs under the Tariff Act of 1930. The similarity in the rules is that neither Customs nor the FTC requires that goods made […]

By |2023-03-14T10:25:17-04:00March 14, 2023|Food, U.S. Customs and Border Protection (CBP), U.S. Department of Agriculture (USDA), U.S. Federal Trade Commission (FTC)|0 Comments
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