August 2009 - Page 2 of 2 - Customs & International Trade Law Firm

Is C-TPAT Certification Really Worth the Effort?

More and more importers/exporters are being stopped and shipments detained and even seized by CBP (U.S. Customs). Many feel they are being targeted by CBP, simply for the type of merchandise or because of the country with which they may be doing business.

While you would think that electronics would be the most sought after, the fact of the matter is that electronics is a small piece of the seizure pie, with the biggest piece going to footwear! Talk about picking a product and running with it!

However, regardless of the industry, the primary reason for detentions is IPR (intellectual property rights) violations. You see, whether its shoes or cell phones, foreign manufacturers need to adhere to CBP protocols, as do U.S. importers and exporters.

One way to make sure that all of your ducks are in a row is to the become CTPAT certified. Benefits are such that importers are 4 to 6 times less likely to incur a security or compliance examination by CBP. That in and of itself is almost reason enough. It’s not a complicated process as long as you are not dealing with fly by night manufacturers, but it is a process nonetheless. Do your due diligence. It’s fairly simple to confirm a licensing agreement. Most trademark and copyright holders have the pertinent contact information online. You could apply […]

By Jennifer Diaz|2015-11-30T19:28:15-05:00August 6, 2009|CTPAT, Import|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

Carrying Cash When Traveling Internationally

There are many reasons to be detained by an officer of the United States Customs and Border Protection (CBP) when returning to the United States, but you wouldn’t think that one of those reasons would be because you have too much cash on you. CBP doesn’t come right out and say “show me the money”, but travelers are required to report monies over $10,000 and a supplemental form must be completed by the traveler. In speaking with many foreign travelers, the big misconception is that taxes, customs duties, or some other fee must be paid to the United States Government on the monies over $10,000. WRONG!

Think about this, who travels with large amounts of money and for what? The most cash heavy travelers are gamblers attending Poker Tournaments, and tradeshow vendors/buyers that travel abroad to make their purchases. Do you really think that they pay customs duties on the cash- NO. On the merchandise possibly, but that’s another blog.

If you do not declare the cash you have and CBP finds it, you will not only forfeit all of your money, but you may also have to pay a penalty and possibly be criminally prosecuted.

In speaking with a few United States Immigration and Customs Enforcement (ICE) officers, CBP is more concerned about where the money came from and the reasons for carrying large amounts of cash than anything else. In today’s economy, could your average Joe Traveler just go to the bank and withdraw $10,000 and travel abroad? The answer is probably not. However, could the average Jane Buyer […]

By Jennifer Diaz|2015-11-30T19:27:24-05:00August 3, 2009|International Travel|0 Comments

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