April 2014

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

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.

“Deeming”

The FDA is proposing to “deem” products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the FD&C Act. The FDA proposed 2 options for public comment. Option 1 extended the definition of “tobacco product” in the FD&C Act to “electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not […]

By Jennifer Diaz|2022-07-08T16:21:19-04:00April 25, 2014|E-Cigarette, FDA Issues, U.S. Food and Drug Administration (FDA)|2 Comments

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

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.

The webinar, hosted by the National Customs Brokers and Forwarders Association of America, Inc. (NCBFAA), will take place tomorrow, April 24, 2014, from 12:00 – 1:30 p.m. (EST).

During this webinar, my colleague Perry Sofferman and I will discuss:

What do you have to do (or not do) to get a $20 million dollar ITAR penalty from the DDTC? A review and explanation of the Esterline case.
OFAC has already issued $161,898,750 in total penalty amounts through March 6, 2014. This amount significantly surpasses the total amount of penalties issued in 2013, only $137,075,560!
Learn why Ubiquiti Networks, Inc. agreed to a $504,225 settlement with OFAC for apparent violations of the Iranian Transactions and Sanctions Regulations.
Learn why Weatherford agreed to a $91,026,450 settlement with OFAC in 2013.
We will explore DDTC and OFAC cases to help you determine what preventive actions you must take to help avoid having to write those checks, or perhaps even suffer worse consequences.
This webinar is geared towards exporters and forwarders who want to assure they learn […]

By Jennifer Diaz|2022-07-08T16:25:35-04:00April 23, 2014|Customs Expert, Export, Pre-compliance|0 Comments

FDA Released Draft Guidance on Prior Notice of Imported Foods

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 […]

By Jennifer Diaz|2022-07-07T10:11:17-04:00April 7, 2014|Customs Broker, FDA Issues, Food, FSMA, Import|0 Comments

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

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

FDA Released Draft Guidance on Prior Notice of Imported Foods

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