FDA News Digest
April 28, 2008 _____________________________________
IN THIS WEEK’S ISSUE
n Pet Food Maker Ordered to Obtain Emergency Operating Permit
n New Regulation Strengthens Safeguards for Beef Consumers
n Drug Approved to Treat Bowel Disorder Crohn’s Disease
n Relistor Approved to Treat Opioid-Induced Constipation
» Safety Alerts/Recalls
Pet Food Maker Ordered to Obtain Emergency Operating Permit
FDA has issued an order requiring that Illinois-based Evanger’s Dog & Cat Food Co. Inc . obtain an emergency permit from FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation, which could result in underprocessed pet foods that can allow the survival and growth of Clostridium botulinum, a bacterium that causes botulism in some animals as well as in humans. For Evanger’s to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard.
New Regulation Strengthens Safeguards for Beef Consumers
FDA has issued a final regulation barring certain cattle materials from all animal feed, including pet food. The rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as “mad cow disease”). The new measure builds on FDA’s 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.
Drug Approved to Treat Bowel Disorder Crohn’s Disease
FDA has approved Cimzia (certolizumab pegol) to help sufferers of moderate-to-severe Crohn’s disease who have not responded to conventional therapies. Crohn’s disease is a chronic, inflammatory bowel disorder that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.
Relistor Approved to Treat Opioid-Induced Constipation
FDA has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Such patients include those with a diagnosis of incurable cancer, end-stage chronic obstructive pulmonary disease from emphysema, heart failure, Alzheimer’s disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from functioning. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.
April 25 — FDA Office of Food Safety Deputy Director Don Kraemer appeared before the U.S.-China Economic and Security Review Commission Hearing on ”Chinese Seafood: Safety and Trade Issues”
April 24 — FDA Center for Food Safety and Applied Nutrition Director Stephen F. Sundlof, DVM, appeared before the House Subcommittee on Health.
Subject: ”Food and Cosmetic Provisions of the ‘Food and Drug Administration Globalization Act’ Discussion Draft Legislation”
April 22 — FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations
Subject: “FDA Actions to Improve Safety of Medical Products with Foreign Components”
› Bertek and UDL label Digitek (digoxin tablets, USP, all strengths) for oral use
Reason for recall: tablets may contain twice the approved level of active ingredient
› Silk Soymilk Chocolate Flavor, 11-ounce plastic single serve bottles printed with both a “use by” date of May 7, 2008 (printed as 05 07 08) and a Universal Product Code (UPC) of 2529360028
Reason for recall: product may contain milk protein not declared on label