U.S. Food and Drug Administration (FDA) Archives - Page 41 of 42

FDA’s PREDICT is Coming!

Beware, FDA will soon have a system to track your performance!

FDA will implement PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting and Import Trade Auxiliary Communications System). Although this is likely the longest acronym known to man, I am looking forward to this new system replace OASIS.

PREDICT will be FDA’s system to target higher risk shipments, and will keep track of importers compliance. PREDICT will make it essential for importers to cooperate with brokers in advance, and utilize the “Affirmation of Compliance” section on customs entry forms — which helps provide to FDA a quick mechanism to prove that you are compliant with FDA regulations.

FDA has many outreach events scheduled to get the word out about the new changes coming with PREDICT. The Florida Customs Brokers and Freight Forwarders (FCBF) is assisting to get the word out and has outreach events in Tampa and Miami.

By Jennifer Diaz|2009-11-02T14:00:00-05:00November 2, 2009|U.S. Food and Drug Administration (FDA)|0 Comments

Made in China, Sold in America

This weekend, I visited both Lowe’s and Home Depot looking for some new plants for my backyard. As I walked by all the newly arrived Christmas merchandise, I casually picked up a few to see where they were made. You guessed it, from Santa to Rudolph, one by one they all clearly stated “Made in China”. I finally did find one item that stated “Assembled in USA from foreign and domestic components.” I was getting frustrated. After all, as a customs and international trade attorney for the past 20 years, including the first 5 as an attorney for U.S. Customs, I have made a living doing international trade. I wondered, what happened to our balance in international trade? What happened to “Made in America”?

Everyone knows that mountains of Chinese goods are daily shipped to and sold in the United States, but what about the reverse. Fortunately, I also have that perspective, as I visit the People’s Republic of China (PRC) at least once a year for U.S. based clients importing from China or Chinese companies selling to the United States. I travel to China on an airplane, am transported to the hotel by car, and sometimes go down to the bar to have a drink. The plane is made by Boeing, the car is a Ford, the hotel is a Sheraton, and the drink is a rum and Coke (Bacardi and Coca-Cola). All of those iconic names are pure Americana.

With 1.4 billion people in China, no wonder American companies,and the rest of […]

By Jennifer Diaz|2019-08-26T20:02:23-04:00October 22, 2009|China, China Trade War, Import, Import Alert, International Business, International Law, International Trade, Supply Chain|0 Comments

How to Get Off the FDA ‘Black List’

What is the FDA ‘Black List’?
The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list (a/k/a the FDA’s ‘Black List’). To check if a company you are doing business with is on such a list, check FDA’s Import Alert page. You can search by country, company, etc. If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States. An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days. The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List
FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’. The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place. For example, if a food product was placed on […]

By Jennifer Diaz|2009-10-19T13:00:00-04:00October 19, 2009|U.S. Food and Drug Administration (FDA)|0 Comments

Medical Devices Seminar

On August 14, 2009, Jennifer Diaz and I will speak at the annual FIME Conference taking place at the Miami Beach Convention Center, Miami Beach, Florida. The FIME Conference is one of the largest trade shows in the United Stated attended by medical device manufacturers, importers, and distributors from throughout the United States and Latin America.

The seminar topic is “How to Effectively Resolve Typical U.S. Food and Drug Administration and U.S. Customs and Border Protection Issues for Medical Devices.”

Medical devices are strictly regulated by the FDA. We will discuss how to handle everyday examples of difficult issues with he U.S. Food and Drug Administration (FDA). FDA issues include what to do if you receive a “Notice of FDA Action” or a “Warning Letter” that could potentially state you must stop producing or importing certain medical devices. FDA may allege that the device is adulterated because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, the FDA may allege that a device is misbranded because you have not submitted a section 510(k) premarket notification to notify the FDA of your intent to introduce the device into commercial distribution for these new intended uses. Your company may have its imported merchandise authomatically detained by the FDA because it is on the “detention without physical examination” list. Fortunately, there is a procedure to get off that list.

Effectively resolving U.S. Customs and Border Protection (CBP) issues includes appropriately responding when CBP says your […]

By Jennifer Diaz|2015-11-30T19:29:05-05:00August 6, 2009|Food, Medical Devices|0 Comments

How To Get Off The FDA ‘Black List’

What is the FDA ‘Black List’?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list (a/k/a the FDA’s ‘Black List’). To check if a company you are doing business with is on such a list, check FDA’s Import Alert page. You can search by country, company, etc. If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States. An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days. The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’. The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place. For example, if a food product was […]

By Jennifer Diaz|2015-11-30T19:25:55-05:00August 3, 2009|Food, Import, Import Alert|0 Comments

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