Browse Category

FDA Issues

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 PracticesCBPEventsExportFDA IssuesImportSpeakingUncategorized

2018 Seminars – We Want to Hear from YOU!

posted by Jennifer Diaz January 17, 2018 0 comments
seminarDTL is Planning Our 2018 Seminars AND WANTS YOUR Input!!
We want our 2018 Seminars to answer the import/export questions you have! Please provide your
comments by voting below!

Please VOTE here!

If you have any specific comments you want to share with us, please email us at info@diaztradelaw.com.

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.

Continue Reading

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.”

Continue Reading

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.

Continue Reading

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?

Continue Reading