On January 4, 2011, President Barak Obama signed the Food Safety Modernization Act (FSMA) into law amending the Federal Food, Drug, and Cosmetic Act (FDCA). The FSMA is an attempt to increase food safety in the U.S.A.; specifically imported food safety. This begins a series of reviews of this new law and some opinion as to what will work, what will not, and what it will mean to foreign food manufacturers and exporters and U.S. food companies of all kinds.
FIRST: What has changed that matters today; right now? Not much. Almost nothing in the new amendments will go into effect until FDA writes some new guidance, writes some new regulations, creates some procedures, or receives some new money. As of yesterday (Jan 4, 2011) FDA has mandatory recall authority. That new authority has been a very long time coming. Frankly most people in the world had no idea FDA could not require a food company to recall unsafe food. It was true before, but not anymore.
However, even this requirement requires FDA to establish some new procedures for holding hearings so a person subject to a “cease distribution” order has the opportunity to argue why the order should be modified or vacated. FDA currently does not have procedures for holding this type of hearing (or to issue this type of order). Therefore, contrary to many opinions out there, even this important new recall authority will be “on hold” for a while.
SECOND: What must you do now that you did not have to do before? Not much, although over the next year or so, that will change. Some of the authorities FDA gained go into effect immediately and require very little effort or resources to implement, but not many.
Records Access: FDA already had access to food company records relating to the manufacturing, processing, packing, distributing, receiving, holding or importing of a food that FDA had reason to believe could cause serious adverse health consequences or death to humans or animals. However, now, under the FSMA amendments, FDA gets access to such records that relate to any other food FDA reasonably believes might similarly be affected. That’s a broader records inspection authority.
Registration: FDA can also immediately require firms to update their food facility registrations (required under the Bioterrorism Act) every two years. Prior to the FSMA, FDA required firms to only update mandatory data elements if they changed. Now FDA can (and will) require all food firms to update their registrations every two years. However, FDA can only require the update to occur between Oct 1 and Dec 31 of an even-numbered year, so you have until October 1, 2012 before you have to worry about this one.
FDA is instructed to immediately increase the frequency of food inspections and can immediately require import certification of certain foods – but FDA received no new money with these amendments (thus it cannot inspect more than it already is, presumably) and it must establish certification requirements and standards before it can require import certifications.
So, for now, the FSMA mostly remains a threat of increased enforcement.
– Benjamin L. England, Founder
