On June 5, 2020, the U.S. Department of Justice (DOJ) charged a Chinese manufacturer with exporting misbranded face masks, purported to be N95 respirators. The criminal complaint against King Year Printing and Packaging Co., Ltd. includes numerous allegations that it violated the Federal Food, Drug and Cosmetic Act (FDCA). U.S. Customs and Border Protection, together with the U.S. Food and Drug Administration (FDA), monitor imports for possible fraudulent or defective products.

Willful Violations of the Law

The DOJ … READ MORE

On May 22, 2020 the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) announced their recommendations to deal with shortages during the COVID-19 pandemic for cloth face coverings, sanitation supplies, disinfectants and personal protective equipment (PPE).  These recommendations apply to the food and agriculture industry specifically, as they need these supplies for worker safety and to minimize interruptions in the food supply chain.

The FDA and USDA recommend that supplies should be distributed to Healthcare, Public Health, … READ MORE

The Emergency Use Authorization (EUA), together with the Food and Drug Administration’s (FDA’s) guidance on COVID-19-related enforcement discretion, were put in place so medical product manufacturers, importers, and distributors can bring certain devices and OTC drugs to market more quickly to combat the COVID-19 pandemic. FDA is taking a risk-based approach as they help increase the availability of these medical products. However, this does not mean that the standards for these devices and drugs have lapsed. FDA continues to hold importers and manufacturers accountable to meet certain safety … READ MORE

On May 5th, the FDA added a very significant new requirement for commercial manufacturers of COVID-19 serology tests that are currently on FDA’s so-called “section IV.D list”: Submit a complete Emergency Use Authorization (EUA) Request to FDA before Monday, May 18, 2020, or FDA will remove the test from the list.  Additionally, the new policy requires commercial manufacturers wishing to have their test added to the section IV.D list to submit a complete EUA Request to FDA within 10 business days of their initial application.  FDA published this … READ MORE

Update 6/10/2020

On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP.  Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination. You can find out more in our newest blog “FDA Revises EUAs … READ MORE

Update 06/10/2020

On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP.  Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination. You can find out more in our newest blog “FDA Revises EUAs … READ MORE

Update 06/10/2020

On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP.  Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination. You can find out more in our newest blog “FDA Revises EUAs … READ MORE

A few months ago, FDA removed a country-wide import alert against cosmetic products from Taiwan for illegal color additives. Notably, the import alert disappeared with little fanfare.

FDA originally issued Import Alert 53-06 in 1985, following the detection of illegal color additives in cosmetics manufactured in Taiwan. As a result, all cosmetics from Taiwan were subject to automatic detention upon import. Although manufacturers in other countries were also found to be using illegal colorants in mascaras, eyeshadow, lipstick and other cosmetic … READ MORE

U.S. Government Accountability Office (GAO) recently issued a report that reviewed the steps FDA takes when removing seafood products from import alert. Although FDA intends to conduct a certain amount of sampling or inspections as part of their decision to remove a product from import alert, GAO found that they repeatedly failed to meet their own sampling and inspection goals.

The U.S. imports most of the seafood we consume, and the import alert program … READ MORE

Update 03/27/2020

Due to the outbreak of COVID-19 FDA has stated that they intend to work cooperatively with manufacturers for the remainder of the year regarding using updated Nutrition and Supplement Facts labels and will not focus on enforcement actions during this time.  FDA previously announced that it would do so for the first six months following the January 1, 2020, compliance date. 

Original Post 12/10/2019

The Food and Drug Administration (FDA) … READ MORE

UPDATE 10/07/2019

The USTR gave notice that there will be no exclusions for importers of the EU goods subject to the retaliatory tariffs. The effective date of October 18, 2019 is based on the date of entry and not the date of export.  So, to avoid the EU tariffs, subject goods must clear Customs before 12:00 a.m., October 18. “Advanced Notice of EU Tariffs, Effective date October 18, 2019.”

Original Post 10/03/2019

The Trump administration … READ MORE

On
September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removing
inactive drug listings from its drug listing database. In other words, inactive
drug listings will no longer be “listed” with FDA, as required by law. A
removed drug listing can be especially harmful for imported drugs as FDA
commonly issues import detentions and subsequent import refusals, if it is not
resolved, for unlisted drugs.

What
is the Drug Listing Requirement?

The
Federal Food, Drug, and Cosmetic Act (FDCA) requires all drug manufacturers,
repackers, relabelers, and salvagers to … READ MORE

FDAImports.com
has entered into a new type of Strategic Partnership with Mesh Intelligence that
will bring together FDAImports.com’s deep technical, advisory and consulting expertise
in FDA, USDA and Customs compliance and regulation, with Mesh Intelligence’s market-leading
predictive food safety and security analytics and management software platform.
Together the two organizations are announcing the launch of Threat
Intelligence, a new service to help the world’s leading food organizations predict,
manage and protect mission critical supplier networks to reduce risk of food
recalls, supply chain disruptions and import delays.

Food recalls, compliance delays and import … READ MORE

Between October 1 and December 31, certain Food
and Drug Administration (FDA)-registered facilities must renew their
registrations. Here are some things you need to know to ensure your renewal is
completed on time.

Medical device
establishments:

• The process of paying the annual Device Facility
  User Fee directly to FDA can take a couple of weeks – but don’t pay it before
  October 1, or it will apply to FY 2019 instead of FY 2020 and will not be
  usable for renewal.
• FDA’s User Fee will be $5,236 for the FY 2020
  renewal … READ MORE

Earlier this week the U.S. Commerce Department announced there is a new draft suspension agreement, which will avoid the need for antidumping duties (ADD). Their press release indicated that after a 30-day notice period, a final agreement could be signed on September 19, 2019. At that point, Commerce would suspend the ongoing antidumping investigation without issuing a final determination.

As we had reported this past … READ MORE

Update 08/15/19

The USTR has confirmed, as we expected, that the additional 10% will be applied based on entry date for both List 4A and 4B.

Original Post 08/14/19

On Tuesday, August 13th the United States Trade Representative (USTR) announced additional details regarding the imposition of the latest tranche of Section 301 tariffs on Chinese-origin products (commonly called “List 4”). The USTR had previously announced that 10 percent tariffs would be imposed on List 4 goods as of September 1, … READ MORE

FDA issued their first Warning Letter to an importer for not complying with the Foreign
Supplier Verification Program (FSVP) that was introduced 8 years ago with the
Food Safety Modernization Act (FSMA).

For this first Warning Letter, FDA selected a food importer that was associated
with an outbreak of foodborne illness. In May of this year (2019), a Salmonella outbreak
was identified as originating from tahini products imported by Brodt Zenatti
Holding. Following current practices, FDA, Center for
Disease Control (CDC), and state health officials worked together to identify … READ MORE

Last week the Food and Drug Administration (FDA) took a critical step towards enforcement of FSVP by creating Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation.” To date, FDA has not taken any enforcement action against an importer for not complying with the regulations, which first went into effect May of 2017. However, … READ MORE

On Thursday, August 1st President Trump announced that on September 1, 2019, he will impose a 10% import tariff on $300 billion worth of Chinese goods (which may potentially rise to 25% in the future). These goods, known commonly as List 4, will include most products that are not already covered by the previous three lists of goods subject to Section 301 tariffs. The President’s decision came after trade negotiations with China fell short once again. After the previously stalled talks to resolve the U.S.-China trade talks were … READ MORE

The Trump administration’s trade war with the European Union
may be escalating. The U.S. Trade Representative (USTR) announced earlier this
week that it is considering adding $4 billion worth of products to an existing list
of $21 billion of goods that could be subject to Section 301 duties.

In April, when USTR published the original list, it gave interested parties the opportunity to appear at public hearings and submit written comments. We’re now seeing a similar process … READ MORE

President Trump announced on Saturday that proposed new
tariffs on Chinese imports (aka List 4 goods) will be delayed as trade talks
resume. Proposed goods on List 4 were to include most products not already
covered by previous tariffs. The U.S. Trade Representative (USTR) had received
written comments and held a public hearing on List 4 earlier in June on the
proposal, which would have added $300 billion worth of goods to the tariffs.

While this certainly is good news for many importers, … READ MORE

The U.S. Trade Representative (USTR) just announced
that applications for exclusion from Section 301 List 3 tariffs will be
accepted starting at noon on June 30, 2019. The last day to submit exclusion
applications will be September 30, 2019.

Exclusions that are granted will be applied retroactively to September 24, 2018 (when the 10% duty was imposed) and will be in place for one year from the date when USTR publishes notice that the exclusion has been granted. To apply for an exclusion, importers will have to provide the … READ MORE

Much of the talk in the United States is about tariffs that are being imposed on Chinese imports by the U.S. government (updates here). However, the Chinese government has been busy with its own set of tariffs on U.S.-origin products.

Over the past year China has imposed tariffs on over $100 billion of U.S.-origin goods. The primary targets have been agricultural products such as meat, dairy, vegetables, and fruit.  Other products include coal, metals, chemicals, and … READ MORE

UPDATE: 06/08/19Yesterday evening President Trump called off the tariff on Mexican goods which had been slated to start on Monday, June 10. 

Original: 05/31/2018President Trump announced yesterday that in an effort to force Mexico to take action on immigration issues, the U.S. will be imposing 5% tariffs on all products imported into the U.S. from Mexico starting June 10th.  The tariffs will rise by an additional 5% per month (rising to 10% on July 1st, 15% on August 1st, 20% on September 1st, and finally … READ MORE

In early May, the U.S. Trade Representative (USTR) increased tariffs to 25% for Chinese products covered by List 3 of the Section 301 investigation.  Now that the tariff rate has risen to 25%, the USTR  announced that it will be setting up a process to apply for List 3 exclusions from the 25% tariffs. Yesterday, the USTR  indicated that it anticipates the application process will open on or about June 30, 2019. 

We recommend importers review their imported Chinese
products to determine whether filing an exclusion application for … READ MORE

The U.S. Trade Representative is proposing additional tariffs of up to 25 percent on Chinese products covering 3,805 full and partial tariff subheadings with an approximate annual trade value of $300 billion.  The proposed list covers essentially all products not currently covered by the Section 301 investigation, with the exception of pharmaceuticals, certain pharmaceutical inputs, select medical goods, rare earth materials, and critical minerals.  The proposed list can be found at https://www.federalregister.gov/documents/2019/05/17/2019-10191/request-for-comments-concerning-proposed-modification-of-action-pursuant-to-section-301-chinas-acts.

As with previous lists, the … READ MORE

UPDATE: 05/10/2019 Customs confirmed yesterday that Section 301 List 3 tariffs will rise to 25%.  However, the new 25% rate will only apply to goods which were exported on or after 12:01 a.m. on May 10th; goods which were exported prior to that date and time will still be subject to the current 10% List 3 rate, even if they’re entered after 12:01 a.m. on May 10th.

The difference in tariff rates may lead to some confusion when making entry in the next several days. Customs has … READ MORE

UPDATE 05/14/2019U.S. Customs was directed to resume suspension of liquidation of entries for fresh tomatoes from Mexica effective May 7, 2019. Margin rates for “All Other Growers and /or Exporters” remain at the 1996 preliminary determination level of 17.56%.Original 04/30/2019The antidumping investigation of fresh tomatoes from Mexico initiated in 1996 and suspended for the past 23 years came back to life! This occurred when the Department of Commerce (DOC) gave Mexico notice of the U.S. intent to terminate the agreement and resume the antidumping investigation. If … READ MORE

Today, on April 11, 2019, FDA issued a final regulation which changes the ingredients permissible for use as active pharmaceutical ingredients (APIs) in hand sanitizers. Effective April 13, 2020, this final rule applies to a variety of consumer antiseptic products, including “rubs, leave-on products, or hand “sanitizers,” as well as consumer antiseptic wipes,” that are intended to be used without water.

FDA decided not to make a final decision regarding three active ingredients: benzalkonium chloride, ethyl alcohol, and isopropyl alcohol. More study … READ MORE

In response to increased needs for Border Patrol agents at
our southern border, U.S. Customs and Border Protection’s Commissioner
McAleenan[1]
announced staff shifts in a recent press
conference. Customs is moving 750 officers from the Ports of Entry to help
with “processing, transportation, and hospital watch” of migrants.

As a result, there are longer wait times for passenger and
cargo at ports of entry along the southern border. There are reports of lines
of trucks several miles long and waits stretching for hours. Besides wait times
at the ports, this … READ MORE

An FDA import alert listing can destroy
a supply-chain, and even result in an import ban. To issue an alert, FDA only
needs to convince itself that one is necessary. Their impact and ease of issuance make import alerts FDA’s primary
import enforcement tool, making it critical for the industry to understand
how someone could be placed on alert.

Each year at Seafood Expo North America,
in Boston, our team fields questions about import alerts. Previously we created
an infographic
describing warning signs that … READ MORE

It’s been eight years since the Food Safety Modernization Act (FSMA) was signed into law. With that, the U.S. Food and Drug Administration (FDA) started issuing new regulations designed to strengthen the food safety system. At the same time, they took the “educate while regulate” approach to compliance and enforcement of new FSMA regulations. Most compliance dates for the seven major rules, including FSVP, have now gone into effect.

Foreign Supplier
Verification Program (FSVP)

The … READ MORE

Update 01/13/2019:Commissioner Scott Gottlieb announced that they have increased surveillance sampling of imported high-risk products. Additionally, the FDA has expanded other activities that they have deemed “excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life.”

Posted 01/11/2019:“FDA Lapse in Funding” is boldly declared on the Food and Drug Administration (FDA)’s website, but what does this mean in realty?

This lapse severely impacts the Agency but during the current
Government shutdown some critical functions … READ MORE

Update 2/25/2019:

Due to communication disruptions during the recent government shutdown, NMFS and Customs have extended the informed compliance period for shrimp and abalone to April 1, 2019.  Update 01/22/2019:

Due to communication disruptions during the recent government shutdown, NMFS and Customs have extended the informed compliance period for shrimp and abalone to April 1, 2019. 

NOAA’s NMFS recently announced they have started an informed compliance period for shrimp subject to SIMP. Although entries will be inspected and audited, if newly … READ MORE

Update 02/25/2019:

President Trump announced yesterday that the U.S. has been making progress in trade talks with China. Therefore, he has decided to delay the increase in tariffs originally set to have taken place on March 2.

Posted: 12/04/2018:

Over the weekend, a meeting between U.S. President Donald Trump and Chinese President Xi Jinping lead to an agreement to delay the previously expected Section 301 tariff increase from 10% to 25% on $200 billion of Chinese goods, including foods, cosmetics and thousands of other products (commonly referred to as “List 3”). List 3 tariffs had potentially been … READ MORE

Romaine lettuce is once again making news with an E. coli-driven food recall.  If it seems that 2018 has seen a substantial increase in food safety-related recalls, you are right on the mark. FDA Commissioner Dr. Gottlieb attributes the higher recall volume to “better technology than ever before to link outbreaks of human illness to a common pathogen,” rather than more unsafe food.

Prior to the Food Safety Modernization Act (FSMA), FDA had to rely solely on the responsible parties to voluntarily recall food products (other than infant formula). Although most recalls are still … READ MORE

Benjamin L. England & Associates, an FDA and Customs Law Practice Strengthens Resources

Miami, FL – The law firm of Benjamin L. England & Associates, LLC (http://benjaminlengland.com/) and consulting practice FDAImports.com, LLC (http://www.fdaimports.com) announced today that Thomas J. O’Donnell has joined the firms to further develop their growing portfolio of regional and national accounts. Tom brings a wealth of experience in the movement of goods between countries. With decades of experience, Tom focuses on Customs and international trade … READ MORE

Export lists can be a useful tool for foreign food safety authorities to verify that commodities exported from the United States originate from a trusted source. These lists serve as an unofficial “certification” that the included establishments comply with U.S. food safety regulations or have claimed compliance with the importing country’s regulations. Certain countries require that exporters of specific food products appear on FDA’s export lists before those products may enter the market. Dairy exports to China, Chile, and the European Union are subject to this requirement, for example. Other shipments that require … READ MORE

Yesterday the White House announced another round of tariffs on Chinese imports which will become effective September 24, 2018. This round of tariffs (referred to as “List 3”) was proposed in July and includes human and animal foods and ingredients, cosmetics, and thousands of other products. The original list has been reduced from 6,031 tariff lines to 5,745. Removed products include some consumer electronics, chemicals, and health and safety products. The tariffs will start at 10% next week and move up to 25% on January 1, 2019.

Exclusion Process Expected for List 3

Importers and … READ MORE

Sometimes things take longer than planned and new due dates impact other commitments. That happened to the FDA, but they prevented a regulation from disappearing with just five days to spare.

Current Good Manufacturing Practice (cGMP) regulations for food go back to 1986 (21 CFR Part 110), and a lot has changed since then. Thus, as part of implementing the Food Safety Modernization Act (FSMA) regulations for the Preventive Controls rule (aka Hazard Analysis and Risk-Based Preventive Controls), FDA took the opportunity to update cGMP regulations too. It also located the updated cGMP regulations to … READ MORE

While public hearings regarding proposed tariffs on $200 billion worth of Chinese products have wrapped up this week, the public comment period doesn’t close until September 6, 2018. Attorneys Jessica Rifkin and Ben England recently spoke with an importer who attended two days of the hearings. She noted that the committee did ask a question of each person who testified, but rarely had follow-up questions. Numerous testifiers indicated that there are few alternative sources for many of the products in question.

This latest round of tariffs (commonly called “List 3”) was proposed on July … READ MORE

The California Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as “Proposition 65” or “Prop 65” has new regulations that take effect on August 30, 2018. The amended regulations do not change the list of almost 900 chemicals identified by California’s Office of Environmental Health Hazard Assessment; however, they do change the labeling requirements for consumer products containing one or more of those chemicals.

The primary responsibility for providing product warnings to consumers is the manufacturer, producer, packager, importer, supplier or distributor. At least one chemical name must be included … READ MORE

Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time.

Medical device establishments:

• The process of paying the annual Device Facility User Fee can take a couple of weeks – but don’t pay it before October 1, or it will apply to FY 2018 instead of FY 2019 and will not be usable for renewal.
• FDA’s User Fee will be $4,884 for FY 2019 renewal season.
• FDA’s system requires users to periodically … READ MORE
  

The FDA has added a new resource to their website: the Data Dashboard, which is aimed to help importers, manufacturers, and processors comply with three separate regulations from the Food Safety Modernization Act (FSMA): the Foreign Supplier Verification Program (FSVP), Preventive Controls for Human Food, and Preventive Controls for Animal Food (or the “supply-chain program”). Each of these regulations requires that either the importer or manufacturer must approve their suppliers and verify that the suppliers are appropriately looking for safety hazard(s), as applicable. As part of the supplier analysis, the importer or … READ MORE

Update 08/13/2018:

The President has directed the USTR to consider raising the tariff level from 10% to 25% on the most recent round of tariffs, described below. As a result, the comment period has been extended to September 6, 2018.

Posted: 07/19/2018:

U.S Trade Representative (USTR) announced last week that new tariffs of 10% will be imposed on a wide variety of goods. With over 6,000 items on a list of goods, this round of tariffs covers $200 billion worth of goods. It includes many food products, including soy, and seafood items such … READ MORE

One food safety agency to rule them all? For decades the U.S. Government Accountability Office (GAO) has called for a single federal agency to oversee food safety. And now President Trump, through the White House’s “Delivering Government Solutions in the 21st Century” plan, has recommended it as well.

The Food Safety and Inspection Service (FSIS), under the U.S. Department of Agriculture (USDA), ensures the safety of meat, poultry, processed egg products, and catfish. The Food and Drug Administration (FDA) under the U.S. Department of Health and Human Services (HHS) has responsibilities over most of … READ MORE

The Transportation Security Administration (TSA) has established various programs to ensure the safety of passengers on onboard passenger aircraft while transporting cargo. One of these cargo programs is the Certified Cargo Screening Program.  The TSA states on its website that the “TSA certifies cargo screening facilities located throughout the United States to screen cargo prior to providing it to airlines for shipment on passenger flights. The program is a practical, supply chain solution, which provides security while ensuring the flow of commerce.”

TSA performs yearly and random audits to the referenced Certified Cargo Screening … READ MORE

Today the White House confirmed the Trump administration’s intent to impose tariffs and other restrictions on Chinese goods with “industrially significant technology.” The 25% tariff would be on top of any existing tariffs on those imports.

As we reported in April, the list of products imported from China to the US may include medicaments, vaccines, immunological products and organic chemicals used by the pharmaceutical industry. A full list of impacted products is expected to be announced by June 15. The White House noted that new tariffs would be implemented “shortly thereafter.” Customs attorney, … READ MORE

(Click Infographic to Enlarge)

Worried about these warning signs? Reach out to us for expert advice from our consultants and affiliated attorneys.

Update 5/29/2018:

US Tariffs on Chinese Pharmaceuticals and Other Products Moving Forward

Posted: 4/04/2018:

Several weeks ago, the Trump administration announced that it would impose new tariffs under Section 301 on certain goods imported from China, without specifying which goods would be impacted (the purpose of the tariffs is to combat China’s alleged unfair trade practices in the areas of intellectual property and technology transfer).  Yesterday (April 3rd), the U.S. published the proposed list of products which would be subject to these new 25% tariffs; if these tariffs are ultimately adopted, they … READ MORE