Insight on Last 6 Months of Biden/Congress on Trade

A lot has happened in the first 6 months of the Biden administration. Notable developments include (at least temporary) resolutions in the large civil aircraft and digital service tax disputes, consensus around a global minimum corporate tax of 15%, lawsuits pertaining to Section 232, increased export controls enforcement, shifting U.S. policy stances on Cuba, and more. However, the most important developments pertain to the ongoing U.S.-China trade war. The U.S. and China are engaged in ongoing negotiations while tensions have risen, a lawsuit challenging Trump’s imposition of 301 tariffs are underway, and a massive U.S. competitiveness bill is being considered in Congress that could bring back broad China tariff exclusions. Join us for a jam-packed hour where we discuss everything that has happened in the world of U.S. trade policy over the past 6 months, and provide insight into how Biden’s trade policies affect industry.

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FDA OPENS NEW FSVP PORTAL FOR IMPORTERS

The Foreign Supplier Verification Programs for Food Importers (FSVP), establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. are safe for consumption. The FSVP was created under the Food Safety Modernization Act (FSMA). These standards of the FSVP are in line with the goals articulated in the U.S. Food and Drug Administration (FDA)  Strategy for the Safety of Imported Food. The FDA seeks to ensure that foreign-manufactured food products are safe for consumption. Further, as discussed in Diaz Trade Law’s previously published blog, the FDA issued its first FSVP warning letter in September 2019, and since then has issued at least 60 more!

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ACE: Auditing Your Export History

Co-Authored by Sharath Patil

If a company or individual believes they have violated export control regulations and the U.S. government is unaware of this violation, proactively and voluntarily disclosing the potential wrongdoing can substantially reduce penalties. A key component of filing a successful voluntary self-disclosure (“VSD”) is uncovering and providing the correct data. Diaz Trade Law has significant experience analyzing ACE export data to evaluate your export compliance and submit successful VSDs that substantially mitigate penalties.

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REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs

Webinar Importing 101 Introduction to US CustomsCo-Authored by Denise Calle

Whether you are new to importing or seasoned, this one-hour webinar is a must attend. Register today to hear directly from this specialized, expert trio on the “Top 10 Tips When Importing to Ensure Compliance” with real case studies:

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FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the  FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

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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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Commerce Department Issues Rule Securing Digital Supply Chains Against Foreign Adversaries

NIST Releases Draft Guidance on Internet of Things Device Cybersecurity | NIST

Co-Authored by Sharath Patil

Background on Securing Information Technology & Communications Supply Chains

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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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US Imposes Additional Tariffs on EU Goods

On Wednesday, January 6, 2021, the Office of the United States Trade Representative (USTR), announced the revision of its Section 301 Action: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute (86 FR 674).

 

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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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