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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

Best PracticesFDA IssuesFood

FDA Targets Vending Machine Operators

posted by Jennifer Diaz September 1, 2016 0 comments

FDAVending_03.54ef4f5d7ed31Co-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. 

Since April 2008, pursuant to New York City Health Code Section 81.50, all Starbucks (and many other restaurants) in New York City have been required to display the calories of each of the menu items. A subsequent study found that this mandatory calorie posting influenced consumers in NYC, causing average calories per transaction to drop by 6%. The study also found that calorie posting did not cause any significant change in Starbucks’ overall revenue.

Now, owners and operators of vending machines across the U.S. are next. Back in December of 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”. This rule is codified at 21 CFR 101.8, and requires vending machine operators who own or operate twenty (20) or more vending machines, or who voluntarily register with FDA to be covered, to declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase. According to the December 2014 final rule, covered vending machine operators must comply by December 1, 2016.

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FDA IssuesFoodImport

FDA’s Declared War on Sugar

posted by Jennifer Diaz June 3, 2016 3 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 PracticesE-CigaretteFDA IssuesImportSeizuresTobacco

The End of Vape Shops, Hookah Shops, & E-Cigs? FDA’s New “Deeming” Laws

posted by Jennifer Diaz May 26, 2016 0 comments

 How to comply

On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.

What Are Tobacco Products and What’s Being Regulated?

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Best PracticesCBPCosmeticsCustoms BrokerFDA IssuesFoodFSMAImportImport AlertMedical DevicesSpeakingU.S.Customs

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

posted by Jennifer Diaz November 6, 2015 0 comments
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:

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Best PracticesBISCBPCosmeticsCubaCustoms BrokerDepartment of Homeland SecurityEventsExportFDA IssuesFoodFSMAImportMedical DevicesOWITSpeaking

3 Part Compliance Seminar Series You DON’T Want to Miss!

posted by Jennifer Diaz August 24, 2015 0 comments
We are excited to announce our upcoming 3 part seminar series on ImportingExporting, and FDA Compliance! Government and private speakers will participate.  
Each seminar will provide resources for new and experienced international trade
professionals including:

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Best PracticesFDA IssuesMedical DevicesSpeaking

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

posted by Jennifer Diaz July 29, 2015 0 comments

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”. 

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