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FDA not ready to start FSMA registration process

By Hank Schultz

- Last updated on GMT

Related tags: Food and drug administration, Dietary supplement

FDA not ready to start FSMA registration process
The Food and Drug administration announced via e-mail alert late Friday that the procedure for food facility registrations will not be ready to be implemented by Monday, Oct. 1, the day the biennial registration procedure was supposed to begin as mandated under the Food Safety Modernization Act.

FDA said it will not be accepting registrations at this time. The final deadline for food and dietary supplement manufacturers to submit the registrations was set by FSMA as Dec. 31.

As of Monday morning, FDA was not sure when the process can begin. "As of today, FDA cannot provide the date by which the website will be live, however it will hopefully be soon,"​ FDA spokesman Sebastian Cianci told NutraIngredients-USA.  As to whether the Dec. 31 deadline will be extended to give companies as much time as originally allotted, he said: "FDA is considering this issue and will announce its decision in the near future."

The re-registration process was the subject of a letter sent to FDA​ by the Grocery Manufacturers Association, joined by a number of other trade organizations in the food manufacturing, food retailing and warehousing industries, a group which included the American Herbal Products Association.

Letter expressed concern over duplicated work

The letter expressed concern over the uncertainty hovering over the process, as there was (and still is) no final guidance from FDA regarding what information a company needs to supply to satisfy the requirement.  The letter went on to say that final guidance is urgently needed, so that companies don’t start gathering information only to have to start over when the final registration forms become available.

Food and dietary supplement manufacturing facilities are already required to register under the 2003 bioterrorism act.  Industry observers say when the FSMA requirements are finalized, they are likely to be similar.

 “Will it be considerably more complicated? I don’t believe it will. The concern isn’t about complexity. We want the instructions to be crystal clear on Monday and we want them not to change,”​ said AHPA executive director Michael McGuffin when interviewed last week about the GMA letter.

FDA recommended that interested industry parties should check FDA’s website​ to keep abreast of FSMA developments, or they can sign up for FSMA updates​. Additional information regarding Registration Renewal may be found on the FSMA Registration page​.

Related topics: Regulation

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