Lesson of the day - Don’t Lie to the government!
This case is about making an intentionally false or misleading statement to the U.S. Commerce Department's Bureau of Industry and Security (BIS). Carol Wilkins, an export manager apparently did, and will now pay $15,000 to the BIS. Important to note is that this export manager was fined individually. RF Micro Devices, Inc., the company Carol worked for, was fined $190,000 separate and apart from Carol. I don't know about you, but shelling out 15k would definitely put a huge dent in my shopping fund.
The BIS Charging Letter discussed Ms. Wilkins' false or misleading statement to the BIS. During the course of a BIS investigation, she allegedly told a BIS Special Agent that all product classifications were confirmed by an outside consultant to be EAR99 (no export license required). Apparently the consultant disagreed, and even kept the documentation in which the consultant had specifically advised Carol that the items were not EAR99, but in fact required a license. Carol might not have realized that the BIS Agents would be resourceful enough to confirm her statements to them by double checking with the consultant. Even I was always taught "trust but verify". Not surprisingly, BIS is no different.
Second lesson of the day, before making a statement you'll regret to government officials, call an attorney first.
Monday, October 26, 2009
Monday, October 19, 2009
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 the 'Black List' because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance. The five shipments must be over a reasonable time period, not one day. Separately, a Petition must be filed with the FDA requesting that the importer be removed from the 'Black List'. The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA's many requirements.
It is wise to know whether you or your company are on the FDA 'Black List', to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off 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 the 'Black List' because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance. The five shipments must be over a reasonable time period, not one day. Separately, a Petition must be filed with the FDA requesting that the importer be removed from the 'Black List'. The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA's many requirements.
It is wise to know whether you or your company are on the FDA 'Black List', to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA 'Black List'.
Monday, October 12, 2009
BIS is Coming to a City Near You!
The Bureau of Industry and Security (BIS) has posted its seminar schedule from now until September of 2010! Seminar topics range from "How To Develop and Export Management and Compliance Program" to "Complying with U.S. Export Controls." The full schedule and registration are here.
Monday, October 5, 2009
Be There or Be Square -- OWIT-South Florida IBWOY Awards
Save the Date!
Please save November 12, 2009, for the Organization of Women in International Trades (OWIT) annual International Business Women of the Year (IBWOY) awards luncheon, honoring exemplary women in the South Florida international trade community. While the details are being fine tuned, I can say that we are doing something different this year. Typically, we raise money for a scholarship for a university student. However, this year, so many of us have been touched by cancer. We recently lost Bunny Schreiber, a beacon in the South Florida trade community, and one of our own Board members is currently fighting cancer. Therefore, this year we would like to raise money for breast cancer awareness and will donate proceeds of our silent auction to the Susan G. Komen foundation. If you have any items you'd like to include in the auction, or are interested in sponsorship, please contact me.
I have to say, I personally have truly enjoyed being a Board member of OWIT for the past four years, and hope you too will get involved! We will elect a new board this December for 2010, please express your interest. We'd love your feedback for future events, and would appreciate new faces on our committees!
Please save November 12, 2009, for the Organization of Women in International Trades (OWIT) annual International Business Women of the Year (IBWOY) awards luncheon, honoring exemplary women in the South Florida international trade community. While the details are being fine tuned, I can say that we are doing something different this year. Typically, we raise money for a scholarship for a university student. However, this year, so many of us have been touched by cancer. We recently lost Bunny Schreiber, a beacon in the South Florida trade community, and one of our own Board members is currently fighting cancer. Therefore, this year we would like to raise money for breast cancer awareness and will donate proceeds of our silent auction to the Susan G. Komen foundation. If you have any items you'd like to include in the auction, or are interested in sponsorship, please contact me.
I have to say, I personally have truly enjoyed being a Board member of OWIT for the past four years, and hope you too will get involved! We will elect a new board this December for 2010, please express your interest. We'd love your feedback for future events, and would appreciate new faces on our committees!
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