Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun's ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

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? 

1. For a limited time, registration is FREE!
2. You have the ability to hear DIRECTLY from CBP and FDA.
3. 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 the Centers of Excellence and Expertise (CEE) and Antidumping & Countervailing Duties (AD/CVD) for CBP, and food importation/FSMA related questions for the FDA. Please email your questions today to info@diaztradelaw.com!

Full details including registration information for BOTH seminars are below. 

May 10, 2017 ( 9 - 11 a.m.)

• ABC’s of AD/CVD & CBP Enforcement
• CLICK HERE for our draft agenda
  • Hear directly from CBP Import Specialists & an industry legal expert
  • TOP Tips when Importing to Ensure Compliance with AD/CVD
  • Valuable opportunity to speak direct with Supervisory Import Specialist with U.S. Customs and Border Protection and legal experts to address any concerns relating to CBP’s role in administering and enforcing imports subject to AD/CVD
  • *** CBP WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE

May 18, 2017 ( 9 - 1 2 p.m.)

• FDA FSMA Compliance Seminar for Importers
• CLICK HERE for our draft agenda
  • Hear directly from FDA & an industry legal expert
  • Overview of FDA requirements for importing food products
  • A discussion of best practices when working with your broker to expedite shipments (ACE, ITACS, PREDICT)
  • Overview of the FSMA, including an overview of the FSVP requirement (which has a compliance date of 5/30/17)
  • Best practices for due diligence and responding to enforcement actions and FDA Notices of Action
  • *** FDA WOULD LIKE TO HEAR FROM ATTENDEES OF THE TRADE COMMUNITY ON WHAT ISSUES OR QUESTIONS THEY WOULD LIKE TO BE ADDRESSED DURING THE PRESENTATION. PLEASE SUBMIT QUESTIONS TO INFO@DIAZTRADELAW.COM ***
• RSVP HERE 

We look forward to seeing you at our World Trade Month events!

DR-CAFTA: Si o No? ( Yes or No?)

Co-authored by Carlos Gimenez.

Just because you are importing a product from a party to the DR-CAFTA Free Trade Agreement, does not necessarily mean that the product will be granted DR-CAFTA treatment by U.S. Customs & Border Protection ("CBP"). Even if 95% of the product is made from components that all originate from DR-CAFTA party nations, that still may not be enough.

If the product has one component that originates outside of DR-CAFTA parties, whether or not the product will receive DR-CAFTA treatment will rely heavily on General Note 29(n), Chapter 61, Chapter rule 2, which states:

For purposes of determining whether a good of this chapter is originating, the rule applicable to that good shall only apply to the component that determines the tariff classification of the good and such component must satisfy the tariff change requirements set out in the rule for that good. If the rule requires that the good must also satisfy the tariff change requirements for visible lining fabrics listed in chapter rule 1 to this chapter, such requirement shall only apply to the visible lining fabric in the main body of the garment, excluding sleeves, which covers the largest surface area, and shall not apply to removable linings.

Case in point, a client requested an alaysis of whether DR-CAFTA would apply to a garment produced of components that all originated in DR-CAFTA party countries, with one exception, the lace that was used to create a decorative front panel. The lace portion of the garment originated in Korea and it only accounted for roughly 17% of the material used overall. In this case, the analysis hinged upon whether or not the lace was the "component that determines the tariff classification", and whether the lace provided the "essential character" of the garment. In this case, the determination was that the lace was in fact the essential character, DR-CAFTA treatment was precluded, and a tariff of 16.5% was applied. If the garment was subject to DR-CAFTA treatment, rate of duty would have been FREE.

The moral of this story, if you want to ensure that the product imported is entitled to DR-CAFTA treatment, do not add any components that would jeopardize that treatment without seeking and receiving an expert opinion and/or a Binding Ruling from CBP. The worst thing that could happen is to work so hard to avail yourself of DR-CAFTA treatment, only to have to pay a double digit tariff for not doing your homework.