U.S. Food and Drug Administration (FDA) Archives - Page 27 of 42

Keep Calm and FSMA Doc On!

The Food Safety Modernization Act (FSMA) is the Food and Drug Administration’s (FDA) most comprehensive reform of food safety regulation. The full Act can be found here. The FDA’s main goal is to make food safer through every step of the process, starting at farms. Imported food is also covered under FSMA, which makes sense as imported food now accounts for approximately 15% of food consumption in the U.S. Rather than focusing on the inspection and response to contamination, the goal of the FSMA is to prevent contamination. Diaz Trade Law covered the changes on June 11, 2015 here.

President Obama signed the FSMA into law on January 4, 2011. FSMA will be implemented slowly in a staggered manner and will be fully implemented by the end of 2017. Implementation varies based on the particular food, company size, and situation, since the FSMA applies to such a broad category. Diaz Trade Law can assist you in learning the basic requirements for FDA regulated products here.

Companies affected by the FSMA will be any company in the food supply chain. Any company that imports, distributes, grows, produces, packages, transports or sells any type of food must be compliant. The company that owns the food is the company responsible for creating a food safety plan. That means that companies that store, carry, or transport the food do not need a food safety plan, but they still must be FSMA compliant.

Diaz Trade Law has compiled 3 top tips to successfully follow […]

By Jennifer Diaz|2016-05-12T21:51:32-04:00May 12, 2016|FDA Issues, Food, FSMA, U.S. Food and Drug Administration (FDA)|0 Comments

Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015
Gallery
Register Now to Meet FDA’s Director of Import Operations and Maintenance – November 12, 2015
FDA Notice of Detention, Liquidated damages, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)

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

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:

Date & Time – November 12th from 9 a.m. – 12 p.m.
Topic – FDA and U.S. Customs Compliance Issues When Importing Food, Cosmetic, and Medical Device Products
Location: Click Here for a Map

Miami Free Zone

2305 N.W. 107th Avenue

Conference Room, 2M10, Miami, Florida 33172

This is a must attend seminar […]

By Jennifer Diaz|2015-11-30T10:29:57-05:00November 6, 2015|FDA Notice of Detention, Liquidated damages, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|0 Comments

We are excited to announce our upcoming 3 part seminar series on Importing, Exporting, and FDA Compliance! Government and private speakers will participate.

Each seminar will provide resources for new and experienced international trade
professionals including:

[…]

By Jennifer Diaz|2016-03-16T00:32:31-04:00August 24, 2015|Best Practices, Cosmetics, Cuba, Events, Export, FDA Issues, Food, Medical Devices, OWIT, U.S Department of Homeland Security (DHS), U.S. Bureau of Industry and Security (BIS), U.S. Customs and Border Protection (CBP)|0 Comments

Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME
Gallery
Calling Medical Device Importers Attending U.S.’s TOP Medical Show, FIME
Customs Expert, FDA Notice of Detention, Import, U.S. Food and Drug Administration (FDA)

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

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”.

My seminar will take place on August 5, 2015, at 10:00 am (EST) in Room D232.

To entice you to attend, here’s a snapshot of the agenda:

Medical Device Basics

FDA Laws/Regulations

FDA Import Process

What You Need to Know to Import

How to Work Best to Expedite Your Shipments with a Customs Broker

FDA Notices of Action

FDA Detention and Refusal Process

Import Alerts

Detention Without Physical […]

By Jennifer Diaz|2015-11-30T10:30:18-05:00July 29, 2015|Customs Expert, FDA Notice of Detention, Import, U.S. Food and Drug Administration (FDA)|0 Comments

IS YOUR COSMETIC PRODUCT REALLY A DRUG?

In Junealone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.

The two main reasons the FDA cited in refusing entry of cosmetic products were:

The products were “misbranded” (lack of adequate directions for use, nutrient content and/or health claims, anti-ageing labeling claims rendering the product a drug; or
The products were “adulterated” (unsafe addition of a color additive).

Definition of a Cosmetic vs. Drug

Misbranding may come down to whether the FDA believes the product is a drug (which is often based on the products intended use, and labeling claims). It is therefore important to know the difference in the way FDA defines cosmetics and drug products, to ensure you label your products correctly.

A product designed for “cleansing beautifying, promoting attractiveness, or altering the appearance,” is generally defined as a cosmeticby the FDA.

A drugon the other hand, is as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.”

Why Cosmetic Products will be Refused by the FDA

One prevalent reason the FDA refuses cosmetic products is because of the claims cosmetic products makes rendering the product a “drug”. A health claim is one example of a type of claim, specifically it is a claim that the product affects the structure and or function of the human body. If your product makes a […]

By Jennifer Diaz|2022-07-07T10:50:38-04:00July 21, 2015|FDA Notice of Detention, Notice of Refusal, U.S. Food and Drug Administration (FDA)|0 Comments

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U.S. Food and Drug Administration (FDA)

Keep Calm and FSMA Doc On!

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

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

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

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

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

IS YOUR COSMETIC PRODUCT REALLY A DRUG?