Regulatory Focus™ > News Articles > New Facility Registration Requirements Come into Effect for Supplement Manufacturers

New Facility Registration Requirements Come into Effect for Supplement Manufacturers

Posted 23 October 2012 | By Alexander Gaffney, RAC

A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA), including for dietary supplement manufacturers.

The requirements of FSMA came into effect on 22 October and mandate that all food production facilities-of which supplement manufacturers are by definition a part-register with FDA to mitigate the impact of any potential security or bioterror event. Previously, FDA had testified that it was unaware of many food production facilities because they did not necessarily need to register with the agency or did not provide them with adequate information.

The new guidance gives the agency the tools it needs to respond to potential threats, it said in the guidance.

"Information about the categories of food a facility handles currently helps FDA conduct investigations and surveillance operations in response to food-related emergencies," wrote FDA. "These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected."

A recent report issued by the US Department of Health and Human Services' (DHHS) Office of the Inspector General found that even under existing law, FDA was supposed to be receiving information from food facilities into a registry so that it could effectively respond to a crisis if such a situation were to occur. OIG found that FDA had not received such information-either not at all, incorrect information or incomplete information-in the overwhelming majority of cases.

FSMA was enacted to rectify many of those concerns by explicitly defining which manufacturers need to register with FDA and establishing what information they need to provide to FDA.

Manufacturers of dietary supplements, proteins, amino acids, fats, lipid substances, animal by-products, extracts, herbals, botanicals, fats, oils, vitamins and minerals will all be required to register with FDA, the agency said. Those registrations will be required whether the product is manufactured, processed, packed or held at a facility.

FDA said the new system will be particularly useful for comparing the facility's registration with products imported into the country.

"For example, if the registration information identifies a facility as producing only dairy products and FDA receives a prior notice for a shipment of nuts purporting to have been produced at that facility, FDA can inspect the shipment for verification based on the discrepancy," it wrote.

The guidance, Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories now supersedes the draft version of the earlier guidance, issued in August 2012.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.