How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes?  $500?  $750?  What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making sure that your registrations and listings are up-to-date and compliant?   $1000?  Many companies are charging prices like these or higher for these services.  There seems to be a mindset in the industry that these services are hugely complex and take many hours, so they’re worth hundreds or … READ MORE

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Generic drug manufacturers and certain others are subject to a new reporting requirement. It is perhaps buried in the Generic Drug User Fee Amendment (GDUFA), which was a part of the Food and Drug Administration Safety and Innovation Act (FDASIA) passed on July 9, 2012. Accordingly, FDA published a Federal Register announcement implementing this new requirement on October 2, 2012. This new requirement takes on a new urgency because the report is due 60 days after that announcement or by December 3, 2012. Failure to self-identify will … READ MORE

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If you remember only one thing about FDA-related legal matters involving imported products it should be this:  Even if FDA issues a “final” FDA refusal on a legal matter, it is still possible to 1) prove that the FDA got it wrong, and 2) convince FDA to reverse itself.

For instance, in late 2011 FDA detained multiple shipments of children’s medicine being imported by a multi-national drug company.  FDA alleged that the drugs appeared to be misbranded and unapproved. Eventually FDA refused all of the shipments. FDAImports.com reviewed … READ MORE

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In February 2012, news of fake Avastin in the United States hit the news wires.  Cancer patients were being administered water while under the impression that it was the actual cancer treatment drug, Avastin.  People were outraged.  Weeks later, another shipment of the counterfeit drug was discovered in the United States.  “What’s being done about this?” was the outcry from the press.  Shortly thereafter, the Senate passed the Counterfeit Drug Penalty Enhancement Act of 2011,1 a bill that had been sitting in committee … READ MORE

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Benjamin England, Founder and CEO of FDAImports.com and ExportToUsa.com.cn, presented on Food and Drug Regulation and Importing Requirements along with Rick Quinn, Principal at the firm, to a delegation of Chinese Food and Drug officials from the Hubei Province this week at a special training event in Chantilly, VA.  The training event addressed the legal requirements for regulating and importing food and drugs into the United States with special attention given to Chinese products and the FDA Food Safety … 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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We warned him. We heard the rumors this was coming and sure enough it did.  The U.S. Food and Drug Administration’s Office of Criminal Investigations (OCI) teamed up with Homeland Security agents of Immigration and Customs Enforcement (ICE) and reportedly arrested Santa Claus tonight as he was out testing a new sleigh configuration in Columbia, MD.  Eyewitness accounts caught the whole event on video, even capturing the agents’ rough treatment of Santa (and his tears) as he was put into the FDA’s special enforcement SUV.  “I saw all this commotion down in the parking lot … READ MORE

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FDA’s Center for Drug Evaluation and Research (“CDER”) is establishing a new office, which in part will focus on drug importations. This move highlights CDER’s increased involvement in determining the compliance of individual drug-shipments imported into the United States. Also, this new office may likely centralize admissibility decisions, leaving the FDA field offices (and importers) waiting for decisions on drug entries. These affects will cause drug-importers greater delays in importing their products … READ MORE

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The FDA has recently made public and easily accessible several databases disclosing the results of FDA inspections for companies with compliance issues related to the Food, Drug and Cosmetic Act and results of criminal investigations and debarment actions along with an easy to use warning letter, untitled letter and cyber letter resource.  Although such information has always been available from FDA, it could only be obtained by a written request under the Freedom of Information Act … READ MORE

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Following the two day FDLI conference, U.S.-China Food and Drug Law, in June 2011, FDAImports.com and ExporttoUSA.com.cn will provide three additional training opportunities FREE in Beijing on June 15, 2011 and in Shanghai on June 17, 2011. These sessions will give attendees the opportunity to receive valuable … READ MORE

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