Friday, April 26, 2013

IS YOUR CONDOM COMPLIANCE SAFE?


Many of you may think of a condom as a way to avoid pregnancy, but to a customs and international trade attorney, men’s latex condoms are Class II “medical devices” regulated by the  U.S. Food and Drug Administration (FDA). There are several compliance issues that arise when attempting to import condoms into the United States.


Attempting to import any medical device into the United States can be a complicated endeavor. Failure to handle these compliance matters ahead of time can lead to an FDA detention and potential FDA refusal of the shipment. U.S. Customs and Border Protection (CBP) and FDA will  investigate several of these compliance requirements when your shipment arrives into the U.S., including:
  • Whether a 510(k) Premarket Notification was approved by FDA for the device;
  • Whether the importer of record filed Device Initial Importer Registration with FDA; and
  • Whether the foreign manufacturer filed the Device Facility Establishment Registration with FDA.
With these compliance matters, cheap becomes expensive very quickly. Regulatory compliance matters are better handled before any shipments are sent. For some information on the requirements for filing a 510(k) premarket notification with FDA for latex condoms, visit FDA's website, click here. For some information on the labeling requirements for men's latex condoms visit FDA's website, click here. For everything else you want to know about condoms, please contact one of the Customs and International Trade Law Group members at GrayRobinson.


Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131

Direct:  305-416-6960

Monday, April 8, 2013

TTB 2012 Annual Report Released

On March 22, 2013, the Alcohol Tobacco Tax and Trade Bureau ("TTB") announced the release of the TTB 2012 Annual Report. TTB is the third largest tax collection agency in the U.S.Government, behind the Internal Revenue Service (IRS) and U.S. Customs and Border Protection (CBP). In 2012, TTB collected $23.4 billion in alcohol, tobacco, firearms and ammunition excise taxes—a decrease of less than a half of 1 percent compared to 2011. Prior to 2008, TTB and its predecessor—the Bureau of Alcohol, Tobacco and Firearms (ATF)—collected between $14 - $15 billion in excise taxes annually. Now, for the fourth consecutive year, TTB tax collections have exceeded $23 billion.




Collection of Excise Taxes
As an agent of the Federal Government and as authorized by 26 U.S.C., TTB collects excise taxes from alcohol, tobacco, firearms, and ammunition industries. TTB collected approximately $78 million less in excise taxes compared to the previous fiscal year. In 2011, TTB collected $23,457,049,000 in excise taxes. In 2012 a decrease to $23,378,944,000.

Fines, Penalties and Interest
TTB collected approximately $3.4 million less in fines, penalties and interest in 2012. In 2012, TTB collected $937,000 in fines, penalties and interest. However, in 2011, TTB collected an astounding $4,361,000 in fines, penalties and interest.

Prospectus for TTB
In forecasting tobacco revenues, Federal collections are expected to decline after peaking at $15.9 billion in 2010. Higher prices on tobacco products have historically resulted in decreased consumption and increased illicit trade, which combined would indicate declining tax revenues in the out years.

TTB efforts in enforcing both its civil and criminal tax jurisdiction support voluntary tax compliance and act to deter illicit trade, and TTB will continue to act to address the revenue threat posed by the diversion of alcohol and tobacco products to ensure the collection of the taxes due.



Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131
Direct:  305-416-6960