April 2017 | Customs & International Trade Law Blog

FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

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By Jennifer Diaz|2022-07-06T15:45:03-04:00April 28, 2017|Best Practices, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|3 Comments

Crash Course in the Harmonized Tariff Schedule of the United States

What is the HTSUS?

The HTSUS is the Harmonized Tariff Schedule of the United States.

This post will give a rundown of what the HTSUS is and why it is so important. The HTSUS was established in 1989 through an act of Congress. This new tariff classification replaced the old Tariff Schedule of the United States.

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By Jennifer Diaz|2021-11-09T13:52:22-05:00April 26, 2017|Export, Import, U.S. Customs and Border Protection (CBP)|3 Comments

FREE World Trade Month Seminar on FDA/FSMA COMPLIANCE for Importers

Flyer

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend?

For a limited time, registration is FREE!
You have the ability to hear DIRECTLY from FDA.
We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

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By Jennifer Diaz|2019-10-21T09:08:25-04:00April 24, 2017|Best Practices, Customs Broker, Events, Food, FSMA, Import, Speaking, U.S. Food and Drug Administration (FDA)|4 Comments

FREE World Trade Month Seminar on AD/CVD & CBP ENFORCEMENT

Flyer. Importers, here is your chance to learn all about the hot topic of AD/CVD. In celebration of World Trade Month, Diaz Trade Law is providing the trade community a valuable opportunity to speak direct with Supervisory Import Specialists with U.S. Customs and Border Protection (CBP) and a legal expert to address your questions and concerns relating to CBP’s role in administering and enforcing imports subject to AD/CVD.

In Fiscal Year 2016, CBP Processed $14 billion of imported goods subject to AD/CVD, and collected $1.5 billion in cash deposits. By the end of the fiscal year, $2.8 billion in AD/CVD duties were still owed to the U.S. (dating back to 2001). From fiscal year 2015 to 2016, AD/CVD cash deposits increased over 25
percent. Learn directly from CBP on AD/CVD Compliance and Enforcement! With President Trumps new Executive Order mandating a plan by June 29 “to require importers deemed a risk to U.S. revenue to provide security for AD and CVD liability through bonds and other legal measures”- many questions arise! Now’s your time to ask them!!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss […]

By Jennifer Diaz|2021-04-09T13:22:00-04:00April 21, 2017|AD/CVD, Customs Broker, Import, U.S. Customs and Border Protection (CBP)|Comments Off

World Trade Month Seminar Series for Compliance Professionals

In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.
In the first seminar, attendees will learn the ABC’s of Antidumping & Countervailing Duties (AD/CVD) compliance and CBP Enforcement.

In the second seminar, FDA will focus on food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? […]

By Jennifer Diaz|2017-05-09T13:52:45-04:00April 20, 2017|AD/CVD, Best Practices, Customs Broker, Events, Food, FSMA, Import, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

President Trump & CBP Aim to Collect Unpaid AD/CVD Duties

On March 31, 2017, President Trump signed an Executive Order (EO) that addressed unpaid anti-dumping and countervailing duties. This new EO, “promotes the efficient and effective administration of U.S. customs and trade laws by establishing enhanced measures to collect duties”.

What are anti-dumping and countervailing duties (AD/CVD)?

Dumping happens when a foreign company exports goods into the U.S. and sells those goods at less than fair market value. This in turn causes “injury to the U.S. industry”. Due to this, U.S. manufacturers or businesses can file a petition with the International Trade Commission (ITC), claiming that it has suffered an injury. Once the ITC finds that evidence of an injury exists, then the Department of Commerce (DOC or the Department) will investigate the claim. If the DOC determines that dumping occurred, then Customs and Border Protection (CBP) can withhold “liquidation of entries” and collect anti-dumping (AD) duties. AD “duties are calculated to bridge the gap back to a fair market value.” […]

By Jennifer Diaz|2021-11-09T14:01:16-05:00April 18, 2017|AD/CVD, Import, U.S. Customs and Border Protection (CBP)|3 Comments

Import Food Products? Deadline to Comply with FSVP is May 30, 2017!

What is the FSVP Rule?

The Foreign Supplier Verification Program (FSVP) was created on November 27, 2015, as “a significant provision of the Food Safety Modernization Act (FSMA)”. The FSVP “shifts the burden of certifying the safety of food imports from [the] FDA to the importers themselves”. This means that importers must set up a program that verifies that both the foreign supplier of the food and the food itself will comply with United States (U.S.) laws.

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By Jennifer Diaz|2021-11-09T14:00:21-05:00April 13, 2017|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|2 Comments

Is “Made in the USA” Really Made in the USA?

Which Federal Agency Regulates the “Made in the USA” Claim?

The Federal Trade Commission (“FTC” or “the Commission”) “is charged with preventing deception and unfairness in the marketplace. The FTC created an Act that would allow the Commission to bring legal action “against false or misleading claims that a product is of U.S. origin”.

When Can I Say Made in the USA?

For a product to be considered as “Made in the USA” without qualification, that product must be “all or virtually all” made in the U.S. How the Commission determines whether a product is “all or virtually all” made in the U.S., by looking at whether there was “a ‘reasonable basis’ to support the claim at the time it is made”. To prove the “reasonable basis” standard, a manufacturer or marketer must provide “competent and reliable evidence” to the FTC.
A qualified Made in the USA claim must describe “the extent, amount or type of [its] domestic content or processing”. This allows the consumer to know “that the product isn’t entirely of domestic origin”. The FTC warns that qualified claims can be tricky, so it is best to “avoid qualified claims unless the product has a significant amount of U.S. content or U.S. processing”.
- Ex: “60% U.S. content. Made in USA of U.S. and imported parts. Couch assembled in USA from Italian Leather and Mexican Frame.”
For a complete understanding of the FTC’s Made in the USA standard, take a look at “Complying with the MADE IN USA STANDARD”.

By Jennifer Diaz|2021-11-09T13:59:29-05:00April 4, 2017|Best Practices|Comments Off