U.S. Food and Drug Administration (FDA) Archives | Page 2 of 14

Biden Executive Order Strengthens Buy American Government Procurement Laws

Biden Signs Executive Order Strengthening Buy American Laws

Buy American laws are a set of statutes, regulations, rules, and Executive Orders that require that the U.S. federal government require or provide preferences for purchasing goods produced in the United States. Buy American laws were created and continue to be amended with the intention of promoting economic and national security, stimulating economic growth, creating good jobs at decent wages, and supporting the U.S. manufacturing and defense industrial bases.

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By Jennifer Diaz|2021-07-26T16:55:04-04:00March 9, 2021|Best Practices, China Trade War, Customs Expert, Enforcement, Events, Export, Import, Import Alert, International Business, International Law, International Trade, U.S. Customs and Border Protection (CBP)|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|2021-07-26T16:56:23-04:00March 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)|0 Comments

CBP Issues WRO on Cotton, Tomato, & Downstream Products Made in Xinjiang

The United States has been increasing its efforts to combat forced labor around the world. During the Trump Administration’s final weeks, the United States not only banned the importation of Chinese Cotton, Tomatoes, among other products, but also explicitly recognized the situation in Xinjiang as a Genocide.

Importers not adequately auditing their supply chains for use of forced labor are at risk of administrative and criminal enforcement. Imported merchandise produced with forced labor is subject to the Department of Homeland Security (DHS) enforcement. Such enforcement includes U.S. Customs and Border Protection’s (CBP) right to detain, exclude, and/or seize imported goods and Homeland Security Investigation’s potential criminal investigation. China is not only the United States’ number one trading partner but also happens to be the world’s biggest forced labor violator.

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By Jennifer Diaz|2021-07-26T16:59:36-04:00February 18, 2021|Best Practices, China Trade War, Customs Expert, Enforcement, Export, Forced Labor, Import, Import Alert, International Business, International Law, International Trade, Pre-compliance, U.S. Customs and Border Protection (CBP)|0 Comments

Biden Administration Commits to Modernizing Regulatory Review

Co-Authored by Sharath Patil

Background on Regulatory Review

U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority: 1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.

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By Jennifer Diaz|2021-07-26T17:03:46-04:00February 9, 2021|COVID-19, Export, Import, International Trade, Trade Policy, U.S. Customs and Border Protection (CBP), U.S. Department of State (DOS), U.S. Food and Drug Administration (FDA)|0 Comments

FDA Import Alert on Mexican Hand Sanitizer

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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By Jennifer Diaz|2021-07-26T17:06:23-04:00February 4, 2021|Best Practices, COVID-19, Customs Expert, Enforcement, Export, Import, Import Alert, International Business, International Law, International Trade, Mexico, Seizures, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments

FTC issues a Record Breaking $1.2 Million Penalty

Co-Authored by Denise Calle

Chemence Inc., a glue maker, is once again in a sticky situation with The Federal Trade Commission (FTC) for allegedly making deceptive claims that its products are made in the United States. In a proposed Consent Order, Chemence agreed to pay $1.2 million for its violation of the FTC Act for violating a 2016 federal court order to cease deceptive marketing tactics, as well as mandated an annual compliance report. The FTC now seeks Public Comment on the proposed consent agreement. The comment period closes on February 8, 2021. Thereafter, FTC will decide whether it should withdraw from the agreement or make it final and force Chemence to pay the $1.2 million penalty.

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By Jennifer Diaz|2021-07-26T17:12:53-04:00January 26, 2021|Best Practices, China Trade War, Customs Expert, Enforcement, Export, Import, Import Alert, International Business, International Law, International Trade, Pre-compliance|0 Comments

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|2021-07-26T17:19:40-04:00January 14, 2021|Customs Expert, Enforcement, Export, Food, Import, Supply Chain, U.S. Food and Drug Administration (FDA)|0 Comments

A Year in Review!

2020 has been a difficult year filled with immense challenge and change (to say the least). From all of us at Diaz Trade Law, we are incredibly thankful and grateful for your support. Despite a pandemic, Diaz Trade Law still managed to save our clients MILLIONS of dollars in 2020. It is with great joy that we finish off 2020 filled with numerous achievements and accomplishments. We look forward to assisting you in what we envision will be a better and brighter 2021!

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By Jennifer Diaz|2021-04-09T13:06:51-04:00December 23, 2020|301 INVESTIGATIONS, Best Practices, China, China Trade War, Counterfeits, Cuba, Currency Seizure, Customs Expert, Enforcement, Export, Forced Labor, Import, Import Alert, International Business, International Law, International Trade, International Travel, IPR, Trademarks and Logos, Medical Devices, U.S. Customs and Border Protection (CBP)|0 Comments

Catch Up on Diaz Trade Law’s Top Blogs From 2020!

We want to make sure you stay up to date with the hottest trade blogs from 2020. Below is a summary of what you missed by category. Enjoy!

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By Jennifer Diaz|2021-04-09T13:08:38-04:00December 23, 2020|Best Practices, China, China Trade War, Customs Expert, Election 2020, Enforcement, Events, Export, Forced Labor, Import, Import Alert, International Business, International Law, International Trade, U.S. Customs and Border Protection (CBP)|0 Comments

USMCA Comment Opportunity – Due Dec. 31

Co-Authored by Sharath Patil

USMCA Background

The U.S.-Mexico-Canada Agreement (“USMCA”) is a free trade agreement that replaced the North American Free Trade Agreement (“NAFTA”) and entered into force on July 1, 2020. The USMCA enjoyed significant bipartisan support and was widely considered a successful effort at “modernizing” NAFTA.

From a labor perspective, the USMCA contains much stronger provisions than its predecessor. Rather than comprising enforceable labor provisions, NAFTA was accompanied by a labor side agreement which only listed guiding principles pertaining to workers’ rights. On the other hand, the USMCA comprises an enforceable chapter dedicated to labor containing strong provisions in favor of workers rights.

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