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April 2014

FDA IssuesTobacco

E-Cigs “Deemed” Tobacco Under New FDA Proposed Rule

posted by Jennifer Diaz April 25, 2014 0 comments

e-cig

On April 24, 2014, the U.S. Food and Drug Administration (FDA) announced what some call a “long- awaited” proposed regulation that will impact the future of the currently booming e-cigarette industry.  Currently, e-cigarettes are not a part of FDA’s purview and have no FDA oversight – FDA’s proposed rule intends to change this in a big way.

How is Tobacco Defined Currently?

Section 201(rr) of the Federal Food, Drug and Cosmetic Act (FD&C Act), (21 U.S.C. 321(rr)),as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), currently defines the term “tobacco product,” as ” any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product… “.

The Tobacco Control Act permitted FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco automatically as “tobacco product” under the FD&C Act.

Section 901 of the FD&C Act  gives the FDA leeway to include “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” and therefore subject to FDA regulation under the FD&C Act.

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Export Penalties Already Total $184 MILLION in 2014 – Want to Learn Who, What, Why & How to Stay Compliant?

posted by Jennifer Diaz April 23, 2014 0 comments
 
Within just the first nine weeks of 2014, almost $182 million dollars in penalties have been assessed against companies for OFAC and ITAR export violations.  Within those same nine weeks alone, companies have been ordered to pay the Department of Treasury almost $25 million dollars more than was ordered in all of 2013. Simply put, compliance is critical, and non-compliance is costly!
 
Don’t miss this update on export enforcement actions stemming from a busy 2013 and start of 2014. 
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FDA Released Draft Guidance on Prior Notice of Imported Foods

posted by Jennifer Diaz April 7, 2014 0 comments

For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry.  We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.

The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”.  Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”

FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004.  The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA.  The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.

Although pursuant to 21 CFR 10.115(g)(5), comments can be made on the guidance at any time, in order to ensure that the FDA considers your comments on this draft guidance before it begins to work on the final version of the guidance, your comments must be submitted either electronically or in writing within sixty (60) days from the date in which the notice announcing the availability of the draft guidance is published in the Federal Register, or March 31, 2014.  If you have questions on FDA’s FSMA or on submitting a comment, please feel free to contact me at (305) 260-1053 or via email at JDiaz@bplegal.com.