The U.S. Food and Drug Administration (“FDA”), for the first time in its history, formally entered into regulating how food is grown and harvested by proposing standards for the safe growing, harvesting, packing, and holding of produce on farms. The Food Safety Modernization Act required FDA to establish minimum standards for minimizing the risk of serious adverse health consequences or death for producing and harvesting raw agricultural food products.  The proposed rules have a comment period deadline of May 16th, 2013.  What exactly … READ MORE

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On January 4, 2013, FDA published its proposed Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) regulations for food facilities, exactly one year after it was required to under the Food Safety Modernization Act (“FSMA”).  HARPC is a new set of food safety regulations that essentially copies existing food safety principles previously only applicable to seafood and juices (HACCP Principles) and applies them to the production of almost all other food types.  FDA posted the proposed regulations today with a comment deadline of May 16th, … READ MORE

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After a full year’s delay the U.S. Food and Drug Administration has finally released some key proposed rules due under the 2011 Food Safety Modernization Act.  These proposed rules include (click on each to learn more):

1.  Hazard Analysis and Risk-Based Preventive Controls (HARPC)

2.  Produce Safety Standards

3.  Current Good Manufacturing Practice (CGMP) changes

Stay tuned to the FDAImports.com blog for more in-depth analysis of the proposed rules and what they’ll mean for industry, food safety and imports.

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The 2012 elections are over!  Celebrate or mourn. But either way, it’s now time to expect some stability and action as the sideshow comes to an end.  As we predicted over the summer FDA did not release any of its new FSMA regulations before the election. In fact, the regulations are still jammed up at the Office of Budget and Management (OMB).  Here are some predictions now that we know where we’re headed under the Obama administration.

FSMA
Expect the current regulations to be released from OMB in coming weeks.  In fact, we have … READ MORE

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1. Does my product comply with federal law?
The USDA administers the National Organic Program (“NOP”). NOP regulations set out the requirements for the handling, certification, processing, composition, and labeling of organic products.  Products labeled as “organic” or “100% Organic” have one set of labeling and certifying requirements. Products labeled as “Made with Organic” (i.e., ≥70% organic ingredients) have another set of requirements. Finally, products declaring the presence of organic ingredients in the ingredient list are exempt from certification, but have other restrictions.

2. Does my product … READ MORE

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FDAImports.com achieved a major victory this month, making life easier for importers of pacifiers. The Automated Broker Interface utilized for making entry with U.S. Customs and Border Protection was originally set-up to force importers to notify and submit information to FDA every time they brought in pacifiers. Only one problem: FDA has jurisdiction over pacifiers–which become a medical device–only when they are intended for teething.

This ABI setup, which forced an FDA submission, often caused FDA to hold the pacifiers under the mistaken belief the pacifiers … READ MORE

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FDAImports.com Founder and CEO, Benjamin England, recently spoke at the Food and Drug Law Institute’s Annual Conference on the Food Safety Modernization Act and imports.  During the presentation, “How FSMA Changed the Game on Imports,” Mr. England discussed, along with leading FDA lawyers and industry and FDA officials, elements related to FSMA affecting imported foods and international trade, including the Foreign Supplier Verification Program (FSVP), the Voluntary Qualified Importer Program (VQIP), various challenges to the international supply … READ MORE

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What happened when observers pointed out that the Congressional Budget Office estimated it would cost $1.4 billion over 5 years to implement FSMA even though Congress only gave FDA a $50 million boost for this year? Silence.  What happened when industry and consumers complained that FDA had failed to propose new rules before the one-year anniversary of FSMA, thus violating the law?  Silence.  And what do we hear now, nearly five months after a draft of proposed rules were sent to the Office of Management and Budget (OMB) … READ MORE

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Why didn’t your kids get what they wanted for Christmas?
Why didn’t your tree have candy canes on it?
What happened to your toy cosmetic kits, sunglasses, chocolates and candy?

Answer: Your stuff was all detained at a U.S. port due to:

• Candy canes having undeclared Red 40 in them.

• Chocolates from China being on import alert for melamine.

• Cosmetic kits having glitter in them which FDA suddenly thinks is a color

• Sunglasses having invalid Impact Resistance Certificates

Santa Claus was on his way to deliver these goodies to your children but was … READ MORE

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Adults, children and regulatory compliance officers alike all reeled last week at the news of Santa Nicolas Claus’ arrest by the FDA’s Office of Criminal Investigations and Immigration and Customs Enforcement.  Eyewitness cell-phone video emerged immediately following the arrest but now FDAImports.com has obtained additional footage and interviews from an amateur journalist at the scene.  The following 2 video clips provide additional details into Santa’s arrest, conversations with agents, the scene of the crime and numerous interviews with bystanders including Mr. Claus’ attorney, Benjamin England.  Mr. England stated that his firm was doing everything possible to hasten the judicial … READ MORE

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The FDAImports.com and ExporttoUSA.com.cn team is eagerly preparing for the Food and Drug Law Institute (FDLI) US-China Food and Drug Law Conference.   This conference, taking place in Beijing, China on June 13 and 14 2011, will bring expert thinkers and top government officials together to discuss food and drug regulation and policy in the United States and China.  This event is hosted by FDLI and FDAImports.com is a platinum sponsor along with GE Healthcare, Pfizer and Medtronic.   Mr. Benjamin England, founder and CEO of … READ MORE

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