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FDA

FDA IssuesFoodFSMAImportInternational Trade

FDA Takes New Steps in Oversight of Imported Foods

posted by Jennifer Diaz February 6, 2018 0 comments

FDA-Inspection-Financial-RiskFDA announced that it has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FDA Food Safety Modernization Act (FSMA). The organization being recognized is ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) based in Milwaukee, Wisconsin. This organization is being recognized because it met the applicable FDA requirements, validated through application review and on-site assessment.  FDA is recognizing ANAB for a five year term of recognition. (For more information on FDA’s standards for recognition, see: Key Facts about the Accredited Third-Party Certification Program) Continue Reading

FDA IssuesFoodImport

FDA Announces Enforcement Discretion Under FSMA

posted by Jennifer Diaz January 25, 2018 0 comments

diceOn January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA), aiming to protect the public by ensuring the U.S. food supply is safe through prevention and enforcement. The FSMA included seven foundational rules, which we summarized in our FSMA: Stay Compliant with DTL’s ‘PICTURE’! blog. Continue Reading

Best PracticesFDA IssuesFoodImportImport AlertInternational Law

Food Importers – Want to Expedite Your Importations with FDA?

posted by Jennifer Diaz January 23, 2018 0 comments

 earthOn January 2, 2018, FDA announced that it expects to begin accepting applications in early 2018 for its Voluntary Qualified Importer Program (VQIP), which we first advised you of back in 2015. VQIP is a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. Below are the most important VQIP questions and answers from the FDA. Continue Reading

Best PracticesCBPCustoms BrokerFDA IssuesFoodImportUncategorized

UPDATE: FDA Delays Compliance Dates for the New Nutrition Facts Label Rule

posted by Jennifer Diaz October 6, 2017 0 comments

 

compliance

In an earlier article, we detailed some of the new changes that would be implemented with the new Nutrition Facts Label rule. That article also provided the compliance dates for the rule. On September 29,2017, however, the FDA proposed yet another deadline extension for food companies to bring their products’ labeling into compliance with the new Nutrition Facts Label rule. Amid concerns of requiring more time to implement the final rules, raised by trade groups and companies, the FDA decided to further delay the compliance dates. The proposed extension dates are January 1, 2020, for companies with food sales of $10 million or more a year and January 1, 2021, for companies with less than $10 million a year in food sales.

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EventsFDA Issues

Don’t Miss FDA’s Upcoming Webinar on ITACS

posted by Jennifer Diaz August 29, 2017 0 comments
fda-logoOn September 5th, 7th, and 11th the U.S. Food & Drug Administration will hold three identical webinars, which will provide information on the evolution of FDA’s Import Trade Auxiliary Communications System or ITACS system “to ensure that trade users are familiar with and understand the new ITACS Account Management functionality.”

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Best PracticesCBPCustoms BrokerFDA IssuesFoodImportUncategorized

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 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 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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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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