On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an …
FDA Approves Vivus Inc.’s Stendra to Treat Erectile Dysfunction
On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis …
FDA Issues Statement on USDA BSE (“mad-cow”) Case
On April 26, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the recent announcement confirming a case of bovine spongiform encephalopathy (“BSE”). The U.S. Department of Agriculture’s (“USDA”) announcement confirming and explaining this case may be …
FDA Publishes Global Engagement Report, Highlighting Efforts Abroad
On April 23, 2012, the U.S. Food and Drug Administration (“FDA”) released its “Global Engagement Report,” a document detailing the various strategies undertaken by the agency to ensure that FDA-regulated products, including foods, medical devices, drugs, etc., are manufactured under …
FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies
On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from …
FDA Warns Consumers of Dangers Associated with Crackers Lacking Proper Allergy Warnings
On April 5, 2012, the U.S. Food and Drug Administration (“FDA”) issued a press release warning consumers not to eat certain crackers because of the potential dangers for those with milk or nut allergies. TWI Foods Inc., the crackers’ manufacturer …
FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination
On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to …
FDA Denies Petition to Ban BPA
On March 30, 2012, the U.S. Food and Drug Administration (“FDA”) denied a request to ban the chemical bisphenol-A, commonly known as BPA, from food and drink packaging materials. The request, made by the Natural Resources Defense Council (“NRDC”), sought …
FDA Proposes Reclassification of Tuberculosis Tests
On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, …
FDA Approves Boniva Generics
On March 19, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of generic versions of the drug Boniva (ibandronate). Boniva, manufactured by Genentech Inc., is a once-monthly tablet used in the treatment and prevention of osteoporosis in women. …