Just Like Fake Avastin, Pending Counterfeit Drug Legislation Doesn’t Do Anything Either
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 Food Safety Modernization Act: The Sound of Silence
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...
We’ve Moved!
FDAImports.com and Benjamin L. England & Associates have officially moved and are now in our new office space. Please note our change of address and new phone number below. Our email, website and fax information will remain unchanged. 810 Landmark Drive Suite 126...
Medical Device 513g Requests: FDA vs. FDAImports.com, The Battle Rages On
FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a...
50 People at FDA Oversee the Entire Cosmetics Industry? Believe it
The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a...
Beijing Tightens Food Safety Control With Lifetime Ban for Violators
Beijing has announced plans to ban people convicted of food safety crimes from investing in and operating related businesses for the rest of their lives. According to the new draft amendment to Beijing Food Safety regulations, companies whose lack of food safety...
FDA Struggles To Be Both Fast and Right, Will it Ever be Both?
As the FDA launches its pilot program related to tracking high-risk foods, we are once again reminded of the ongoing difficulties FDA experiences when it comes to choosing between acting quickly and acting thoughtfully. Think back to 2011’s food safety crises...
FDA’s 2013 Budget is a User Fee Buffet- Grab a Plate
FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap...
FDAImports.com Succeeds: First FDA Green Ticket Exemption from Melamine Import Alert #99-29 for Food from China
FDAImports.com recently helped a Chinese company obtain the first Green Ticket from FDA Import Alert #99-29, a sweeping and unshakeable Import Alert for Chinese protein products due to the presence of Melamine and/or Melamine Analogs. This Import Alert traces back to...
FDAImports.com Gets Company off Import Alert #36-04, Honey and Syrup With Fluoroquinolones
FDAImports.com recently achieved another Import Alert success for one of its clients, this time for FDA Import Alert #36-04, "Detention Without Physical Examination of Honey and Blended Syrup Due to Presence of Fluoroquinolones." FDA implemented this Import Alert...