If you import medical devices into the U.S. (or want to), FIME is the trade show for you. Last year, FIME surveyed attendees and received feedback that 52,890 FIME attendees were interested in 25 categories of medical device products. FIME is the #1 Medical Show, and the #1 Medical Trade Fair – and takes place from August 5-7, in my home town, at the Miami Beach Convention Center. Since 2010, I have had the privilege to be a speaker at FIME and had some of the
largest groups of attendees to discuss compliance with the FDA, and how to resolve typical FDA and CBP issues.
I’m thrilled to say I’m speaking again this year. My topic is “How to Effectively Resolve Typical U.S.
Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices”.
In June alone, the U.S. Food and Drug Administration (FDA) refused the importation of over 200 different shipments of Cosmetics from 22 different countries.The two main reasons the FDA cited in refusing entry of cosmetic products were:
President Barack Obama announced Wednesday that the U.S. and Cuba will now reestablish diplomatic ties and reopen embassies in their respective capitals. The announcement comes just one month after the Secretary of State removed Cuba from the State Sponsor of Terrorism list. Although it would take an act of Congress to lift the trade embargo, reopening embassies is another brick in the foundation of normalizing trade relations. With the new embassies opening in July, there will be greater contact between the US and the Cuban people which will ultimately lead to a change in the US’s attitude towards the trade embargo.
On Monday, President Obama signed Trade Promotion Authority (TPA) into law. TPA, also known as the “fast track” bill, was seen as a crucial component in solidifying the Trans-Pacific Partnership (TPP). Although the re-authorization of TPA grants the President greater authority in his ability to negotiate and secure a trade deal–thus speeding up the TPP negotiation process–the TPP still has some tough negotiations ahead. However, the new authority Congress granted the President will now give him the power needed to ultimately conclude negotiations on the TPP.
On Tuesday, June 23, 2015 at 12:00 noon EST, join OWIT International for an insightful conversation about rapidly evolving business opportunities in Cuba.
The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. FSMA requires FDA to establish a voluntary, fee-based program, named the “Voluntary Qualified Importer Program” (VQIP) which promises expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.
On June 4th, 2015 the FDA published a draft version of “Guidance for Industry: FDA’s Voluntary Qualified Importer Program (VQIP)”. According to FDA’s website, VQIP will also benefit consumers by enabling the FDA to focus its resources on high risk foods, further protecting consumers from the potential health hazards associated with those foods. In order for a food importer to be eligible for the VQIP program, the importer should:
- Have at least a 3 year history of importing foods
- Have a Data Universal Numbering System (DUNS) number
- Use a paperless filer/broker who received a passing rating during their last FDA evaluation
- Import food that is not subject to an import alert or Class 1 recall
- Not be, nor any non-applicant entity associated with the VQIP food be, subject to an FDA administrative or judicial action, have a history of significant non-compliance with food safety, or have one or more voluntary food recalls
- Assure compliance with several FSMA regulations
- Possess a current facility certification
- Have a clear 3 year history with U.S. Customs and Border Protection (CBP), meaning no CBP penalties, forfeitures, or sanctions.
- Pay the annual VQIP user fee before October 1st of the intended year of participation (FDA estimated flat fee of $16,400 annually), and
- Develop and implement a Quality Assurance Program (QAP)
Having a robust QAP program is one of the most vital components to have in place to qualify for VQIP and will be one of the largest hurdles for eligibility for those that do not have a QAP program in place. QAP is a compilation of the written polices and procedures a food importer will need in order to ensure adequate control over the safety and security of the foods to be imported. The QAP portion of the VQIP application will be time consuming and difficult to navigate, but with expert help, it can be manageable. FDA believes financial benefits of VQIP will outweigh the efforts in the application process.
FDA estimates that the VQIP program will officially commence in January, 2018.
If you have comments about the draft VQIP, especially the estimated annual fee of $16,400, FDA wants to hear from you by August 19, 2015. FDA will review all comments and publish the final fee in a future Federal Register notice at least 60 days prior to the start of the program.
All food importers that want a faster, streamlined supply chain should consider participation in VQIP. For more information on VQIP, or assistance in developing your QAP program, or want to make sure your voice is heard during the comment period, contact me anytime at email@example.com.
As you know, the President made a big announcement back in December, 2014 that the US would take historic steps to chart a new course in our diplomatic relations with Cuba. One specific action item was instructing the Secretary of State to immediately launch a review of Cuba’s designation as a State Sponsor of Terrorism, and provide a report to the President within six months regarding Cuba’s support for international terrorism.
Within four months of the President’s announcement, on April 8, 2015 (2 months early!), the Secretary of State finalized their review and recommended that Cuba no longer be designated as a State Sponsor of Terrorism. Thereafter, on April 14, the President sent Congress the statutorily required report indicating the Administration’s intent to rescind Cuba’s State Sponsor of Terrorism designation, including the certification that “Cuba has not provided any support for international terrorism during the previous six-months; and that Cuba has provided assurances that it will not support acts of international terrorism in the future.” Members of Congress, initially vowing to block the removal of Cuba from the “terrorism list” had no legal outlet to voice their opposition, and as of today, the 45-day Congressional pre-notification period has expired. As a result, the Secretary of State has officially made the final decision to rescind Cuba’s designation as a State Sponsor of Terrorism, effective today, May 29, 2015.
The Department of State issued a Press Statement today advising that:
The rescission of Cuba’s designation as a State Sponsor of Terrorism reflects our assessment that Cuba meets the statutory criteria for rescission. While the United States has significant concerns and disagreements with a wide range of Cuba’s policies and actions, these fall outside the criteria relevant to the rescission of a State Sponsor of Terrorism designation
Below are the top 4 impacts I foresee as a result of Cuba being removed from the State Sponsor of Terrorism List (leaving only Iran, Sudan, and Syria now on the list):
Are you in South Florida and thinking of doing business with Cuba? Do you want to hear from those already successfully doing business with Cuba? Do you want to fully understand what is legal now?
May 14, 2015, I have JUST the event for you! This is your LAST CHANCE to register!