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!

Register Now to Meet FDA's Director of Import Operations and Maintenance - November 12, 2015

Do you need to know the current issues affecting importing and exporting for international trade professionals?  What about common compliance issues when importing food, cosmetics, and medical devices?  If you answered yes, you will not want to miss the last of our three-part seminar series that will cover these topics and much more.  Plus, members of supporting organizations, clients of Becker & Poliakoff, and future members and clients, will receive a discount!  Here's all the information about our upcoming seminar:

Calling Medical Device Importers Attending U.S.'s TOP Medical Show, FIME

If you import medical devices into the U.S. (or want to), FIME is the trade show for you.  Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair - and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.  

I'm thrilled to say I'm speaking again this year. My topic is "How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices".

IS YOUR COSMETIC PRODUCT REALLY A DRUG?

In June alone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

FDA Discusses TOP Reasons for Detention of Goods

At today’s Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA’s Joint Team 488 – which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

•Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act. (You can Register with the FDA here: www.FDA-USA.com)

•Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Incorrect or missing statement of identity

3.Failure to list allergens

4.Failure to declare ingredients

5.Failure to include a proper “Nutrition Facts” label (incorrect formats for Nutrition Facts labeling is also common) required by 21 C.F.R. 101.9

6.Color additives are not declared correctly (or at all) on the label or not certified

7.Food additives are unsafe or not declared on the label

Dietary Supplements Top Rationales for Detention

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve dietary supplement labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Unauthorized health claims

3.Undeclared active ingredients

4.Lacks a “Supplement Facts” panel required by 21 C.F.R. 101.36

5.Failure to list the name of product and “Dietary Supplement” or “Herbal Supplement” on the label

6.Failure to list the appropriate disclaimer necessary when claims are made

Cosmetics Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-38 for cosmetics labeled with drug claims)

•The cosmetics are contaminated and unsafe to use

•The cosmetics are manufactured under unsanitary conditions

•The cosmetics contain a non-permitted color additive

•Product labeling is not compliant (FDA does not pre-approve cosmetic labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Labeling is missing ingredients

3.Label lacks warnings and adequate directions for use

4.Missing the net quantity of contents

5.Cosmetic contains a “drug” claim

Drugs Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-41 – Unapproved new drugs)

•Drugs are not registered or listed with the FDA

•Product labeling is not compliant (FDA does not pre-approve drug labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label does not contain adequate directions for use

3.Active Pharmaceutical Ingredients (API) is not properly labeled or listed

4.Drug contains a “new” chemical or a different dosage making the product a “new drug”

Medical Devices Top Rationales for Detention

•The manufacturers is not registered with the FDA

•The initial importer is not registered with the FDA

•The device is not listed with the FDA

•The product does not contain a 510k or PMA

•Product labeling is not compliant (FDA does not pre-approve medical device labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label is false or misleading

Bottom line, as you can see, it is up to you, the importer to perform pre-compliance and assure you get compliance right before you import. FDA expects you to know the requirements and has little mercy if you don’t. Assure you stay compliant and avoid the top rationale for FDA to detain your goods by hiring someone that is extremely knowledgeable with FDA’s laws and regulations and continually stays up to date with the constant changes.  Contact me with any questions!