U.S. Food and Drug Administration Archives | Customs & International Trade Law Blog

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 Jennifer Diaz|2023-05-24T12:27:23-04:00May 24, 2023|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

FDA Webinar on Human Drug Importations

On January 14, 2021, the United States Food and Drug Administration (FDA) kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference. The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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By Jennifer Diaz|2022-07-07T12:33:06-04:00March 2, 2021|Best Practices, Customs Expert, Enforcement, Events, Export, Import, International Business, International Law, International Trade, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

Comment on FDA’s Proposed Rule – French Dressing

On December 21, 2020, the Food and Drug Administration (FDA) proposed a rule to revoke the Standard Of Identity (SOI) for French dressing. FDA found that French dressings’ current standard of identity “no longer promotes honesty and fair dealing in the interest of consumers”. Effectively the amending of the SOI may allow producers more flexibility, keeping the market competitive with nonstandardized foods.

According to the Federal Register Notice, the proposed rule would not require anything new from salad dressing manufacturers. Rather, by providing the flexibility for innovation, the amendment to French Dressing’s SOI presents an opportunity for social benefits at no cost to the industry or consumer.

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By Jennifer Diaz|2021-10-12T15:05:30-04:00January 14, 2021|Customs Expert, Enforcement, Export, Food, Import, Supply Chain, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Issues Guidance Documents on Food Facility Registration

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Constituent Update

August 17, 2018, the U.S. Food and Drug Administration (FDA) issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).

One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration. […]

By Jennifer Diaz|2022-07-15T12:02:14-04:00September 18, 2018|Food, FSMA, Import, Import Alert, International Law, International Trade, U.S. Food and Drug Administration (FDA)|2 Comments

Reconditioning Imported Food Refused by the FDA

The U.S. Food and Drug Administration is increasingly stopping and examining imported shipments of food attempting to enter the United States. Often, the FDA does not allow the food to enter the United States by declaring it to be misbranded or adulterated. Typically, refused food is then either destroyed or exported from the United States. There is another option called "reconditioning".

By Jennifer Diaz|2019-10-22T01:31:01-04:00May 15, 2011|Food, U.S. Food and Drug Administration (FDA)|Comments Off

FDA To Inspect Foreign Food Facilities Starting October 1, 2010

The U.S. Food and Drug Administration has issued notices to foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011. Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act. Foreign food facilities that do not properly respond to the FDA notices will result in a detention of any food that arrives in the United States from those canceled facilities.

By Jennifer Diaz|2010-08-11T19:34:53-04:00August 11, 2010|Food, U.S. Food and Drug Administration (FDA)|1 Comment