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FDA Extends Compliance Dates for the New Nutrition Facts Label Rule

posted by Jennifer Diaz August 11, 2017 0 comments

 

Nutrition FactsTake a look at any food label. Check out the back panel entitled, “Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars.

On May 20, 2016 the FDA finalized the new Nutrition Facts label final rule for packaged foods. It was the first major update, and regulation, to the nutrition facts label in 20 years. The FDA’s regulation targeted sugars, in particular “added sugars”, and provided a major update to the amount of nutrients people customarily consume. Additionally, the nutrition facts label received a face lift.

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Best PracticesFDA IssuesImportMedical Devices

Does Your Medical Device Have a Unique Device Identification (UDI)?

posted by Jennifer Diaz June 14, 2017 0 comments

We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. Continue Reading

Best PracticesFDA IssuesImportMedical DevicesU.S.CustomsUncategorized

WHAT DO CONTACT LENSES, DENTAL FLOSS, AND PACEMAKERS HAVE IN COMMON?

posted by Jennifer Diaz June 12, 2017 0 comments

Medical DevicesOne might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

What is a Medical Device? Continue Reading

Best PracticesCBPCustoms BrokerDepartment of Homeland SecurityE-CigaretteFDA IssuesImportImport AlertInternational TravelSeizuresTobaccoU.S.Customs

HELP! CBP Seized My Tobacco Products as Drug Paraphernalia, What Now?

posted by Jennifer Diaz May 30, 2017 0 comments

USMap_Marijuana

Our office has increasingly received requests for guidance on importation of marijuana paraphernalia products to the U.S. where twenty-six (26) states have legalized the use of marijuana for medical purposes and/or personal consumption such as California, Massachusetts, Maine and Nevada. The purpose of this article is to dispel the confusion as to why paraphernalia products (grinders, storage containers, rolling paper, pipes, vape pens, etc.) are continuously being seized by U.S. Customs and Border Protection (CBP), even when such products may be used by tobacco smokers. It is important to address the realities between federal and state laws regulating drug paraphernalia products so importers can avoid CBP’s enforcement of U.S. Laws.

Why Does CBP Stop Drug Paraphernalia?

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Best PracticesCBPCustoms BrokerEventsFDA IssuesFoodFSMAImportImport AlertSeizuresSpeakingU.S.Customs

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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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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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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