News

Under the new and important Food Safety Modernization Act (FSMA), FDA was supposed to commence food facility re-registrations yesterday. This was mandated by section 102 of the FSMA law, enacted in 2011.

This piece of the FSMA puzzle is not off to a propitious start. It was bad enough that there was not much guidance or clarity about how this would work, before the October 1, 2012 to December 31, 2012 re-registration period began. But it’s even worse that the brief window for required and biennial re-registration began yesterday — and yet there is still no means by which to accomplish what is required. The renewal website was briefly available last week, for a few hours, then it froze, then it disappeared, to be replaced with an oh so calm assurance that:

Biennial Registration Renewal for Food Facilities will not be available on October 1, 2012.  We therefore will not be accepting food facility registration renewals at this time.

Continued here.

October 19, 2012, 9 pm ET Update: FDA has announced that “Biennial registration renewal for food facilities will begin at 12:01 a.m. on October 22, 2012. At that time, the system will be accepting food facility registration renewals.” After many months of discussion and a few weeks of delay, FDA seems ready to get the ball rolling on renewals for all those registrations submitted over the past nine years or so.

• October 22, 2012, 10:20 am ET Update: despite all this, statutory mandates, and more than a year to get ready, FDA’s site is still not ready. It grinds for a few minutes then times out. The system is not useable as of today.
• October 22, 2012, 1:50 pm ET Update: broken.
• October 22, 2012, 11:33 pm ET Update: broken. Different computer, same result. Is it only me? FDA is not in a strong position to press others to adhere to various deadlines when FDA does not meet deadlines.
• October 23, 2012, 8:55 am ET Update: broken. When will FDA fix or explain this problem? This more or less ignores the problem.
• October 23, 2012, 9 pm ET Update: finally it seems to be working fairly smoothly.

On Monday, November 26, 2012, Food and Drug Commissioner Margaret Hamburg issued an order suspending the food facility registration of Sunland Inc., a New Mexico-based producer of peanut products. The food facility is alleged to have produced peanut products containing strands of Salmonella, which can cause serious adverse health consequences for humans. FDA inspected Sunland’s plant in September and October 2012 during a month-long investigation, and found samples of Salmonella throughout Sunland’s plant, in nut butter samples, and in a sample of raw peanuts.

The suspension order means Sunland cannot introduce food products from its facility into interstate or intrastate commerce unless the order is vacated or remanded. See Letter to Sunland Inc. Concerning Suspension of Food Facility Registration. The suspension of its FDA registration effectively shuts Sunland down and prevents the company from selling its products.

The suspension of Sunland’s registration is an exercise of FDA’s new suspension powers brought about by the 2011 Food Safety and Modernization Act (“FSMA”). For more information on the suspension of Sunland’s FDA registration, see In a FSMA First, FDA Suspends a Food Facility’s Registration.

As the top story at this hour, The New York Times reported that “The Food and Drug Administration on Friday proposed two sweeping rules aimed at preventing the contamination of produce and processed foods, taking a long-awaited step toward codifying the food safety law that Congress passed two years ago.”