FSMA facility registration: ‘It’s an easy one for industry,’ says CRN’s Mister, ‘so remember to register!’

By Stephen Daniells

- Last updated on GMT

FSMA facility registration: ‘It’s an easy one for industry,’ says CRN’s Mister, ‘so remember to register!’
Dietary supplement companies have six weeks to ensure they have registered their facilities with FDA to comply with FSMA, an issue that is easy to fix for the industry, says Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN).

“The industry doesn’t need more bad publicity because someone failed to register their site. There is no fee,” ​he added, “so just go and tell the FDA that you’re out there,”​ Mister told NutraIngredients-USA.


A recent report from the Office of Inspector General of the Health and Human Services​ department stated that, of 79 companies interviewed that had one or more facilities that should have been registered, 28% had not registered their facilities with FDA as required by the 2002 Bioterrorism Act.

In addition, officials at 32 of the 86 companies interviewed for the report were unaware of FDA registration requirements, leading the authors of the report to question whether companies were keeping the registry up to date.

While Mister questioned the companies included in the HHS report, noting that they were a non-representative sample of the industry since they focused on weight loss and immune function product, he said that the report did raise some concerns about registrations.


The association embarked on a program to raise awareness of the registration requirements amongst its membership and beyond, with CRN staffers attempting to visit all the exhibitors at the recent SupplySide West show in Las Vegas.

Companies should not be complacent about registrations, with Mister noting that some in industry have told him: “We took care of that a year ago”​.

While the 2002 Bioterrorism Act required a one-time registration, the Food Safety and Modernization Act (FSMA) changes this and requires that companies re-register facilities every two years between October and December of the even year.

FDA only opened registration on October 22, 2012​ and the deadline for the registrations to be completed is December 31. Facilities registered a year ago must be re-registered, and more information is required this time around.

Companies can reference the document​ on FDA’s website on the FSMA registration process. The document includes an FAQ section as well as a link to the full text of the law​, a guidance on food categories​, and a guide to using the online registration tool​.  Companies have the option to mail in a form if they so choose.

“If you are not a member of a trade association there is the potential to create bad press by not registering,”​ said Mister. “Please be sure you register.”

Related topics Regulation & policy GMPs, QA & QC

Related news

Show more

Follow us


View more