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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

posted by Jennifer Diaz May 19, 2017 0 comments

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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Best PracticesFDA IssuesImportMedical Devices

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

posted by Jennifer Diaz April 28, 2017 0 comments

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 insigns 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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Best PracticesCustoms BrokerEventsFDA IssuesFoodFSMAImportSpeaking

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

posted by Jennifer Diaz April 24, 2017 4 Comments

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? 

  1. For a limited time, registration is FREE!
  2. You have the ability to hear DIRECTLY from 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 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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AD/CVDBest PracticesCBPCustoms BrokerEventsFDA IssuesFoodFSMAImportU.S.Customs

World Trade Month Seminar Series for Compliance Professionals

posted by Jennifer Diaz April 20, 2017 0 comments

WORLD TRADE MONTH Seminar Series FlyerIn 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?  Continue Reading

FDA IssuesFoodFSMAImport

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

posted by Jennifer Diaz April 13, 2017 2 Comments

FSVPWhat 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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ExportFDA IssuesImportMedical Devices

Medical Device Registration Made Easy!

posted by Jennifer Diaz January 27, 2017 1 Comment

Screen Shot 2017-01-26 at 1.40.53 PMThis article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.” The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

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Best PracticesBISCBPCosmeticsCubaEventsExportFDA IssuesImportIPR, Trademarks and LogosSeizuresSpeakingU.S.Customs

Top Successes of Diaz Trade Law (DTL) & Diaz Trade Consulting (DTC) in 2016!

posted by Jennifer Diaz January 26, 2017 0 comments

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DTL saved clients MILLIONS of dollars in 2016, below we list a summary of some of our compliance successes!

U.S. Customs & Border Protection (CBP)

  • Assisted an importer in having $434,486.00 worth of goods seized returned to it in a RECORD 24 working days, with a signed settlement agreement with CBP in a record 17 working days!
  • Assisted an importer in having $324,466.00 worth of goods seized for an underlying AES violation returned.
  •  Assisted importers in filing prior disclosures that were accepted by CBP, advising of errors found, and avoiding substantial penalties.
  •  Assisted importers in successfully responding to CBP 28’s and 29’s resulting in close outs, and no further enforcement action by CBP!
  •  Assisted importers in creating and maintaining pre-compliance programs to evaluate intellectual property rights and pre-report merchandise to CBP resulting in expedited entry into the U.S. with no delays or examinations by CBP.

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FDA IssuesFoodFSMAImport

FSMA: Stay Compliant with DTL’s ‘PICTURE’!

posted by Jennifer Diaz January 12, 2017 1 Comment

FSMA todo listEach year, according to the findings of a Center for Disease Control and Prevention study, 48 million people (1 in 6 Americans) get sick, 128,000 people are hospitalized, and 3,000 people die as the result of food-related diseases. Instead of reacting to this news on a yearly basis, the U.S. Food and Drug Administration (FDA) decided to do something about it (although not fast enough, some would say) by enacting the Food Safety Modernization Act (“FSMA”). This law, which went into effect on January 4, 2011, aims to protect public health and ensure food safety by placing a greater emphasis on prevention, compliance, and enforcement.

We’ve summarized the seven foundational rules of FSMA for you below. The compliance elements which food facility owner/operators, growers, suppliers, importers, consignees, carriers, and/or accreditation/certification bodies should, at a minimum, incorporate into their 2017 actions plans are highlighted in red (information regarding compliance deadlines for different size-based categories of business can be viewed here). Diaz Trade Law has extensive advising clients on FDA matters and welcomes the opportunity to help your company get FSMA compliant.
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FDA IssuesImport

19 Antibacterial Soap Ingredients to be Banned by the FDA!

posted by Jennifer Diaz November 17, 2016 0 comments

Co-authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law. dsc_60821

Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection. Continue Reading