Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products. Many of our clients have noted the increased scrutiny of products at the US border. Products that had been successfully imported for a number of years are now being detained due to increased inspections. Product from new importers into the US are basically guaranteed that their import will be held for inspection, which may include testing to ensure that levels of nutrients declared on labels are met as well as to determine whether the product is contaminated with bacteria or even laced with pharmaceutical compounds.
At the same conference, FDA Associate Commissioner for the Office of Regulatory Affairs, Michael Chappell, noted that in 2010 FDA has already issued a record number of warning letters to companies importing, manufacturing and distributing FDA-regulated products. Many of these have gone to food, dietary supplement and cosmetic companies. The importance of FDA inspections is apparent since, as stated by FDA Chief Counsel, Ralph Tyler, 25% of the US economy is comprised of FDA-regulated products.
At Bioscience Translation & Application your success is our success and we work with our clients to ensure compliance with FDA regulations. Contact us for product development, labeling and claim substantiation help with your FDA-regulated products or visit us at www. BioTransApp.com