FDA Updates Small Business Guide on Food Facility Registration Requirements
The Food and Drug Administration on May 25 announced the availability of an updated guide to help small businesses comply with food facility registration requirements. The new version of FDA’s small entity compliance guide includes information about the agency’s July 2016 final rule that overhauled food facility registration requirements (see 1607130018), including provisions requiring confirmation by the entity listed as U.S. agent on a facility’s registration.
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The small entity compliance guide “explains which types of facilities are required to register, and when and how to do that,” FDA said. “The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the [guide] includes an ‘At-a-Glance’ that summarizes all of the key information in the document.”
The section on U.S. agent verification procedures says FDA will give a U.S. agent listed on the registration 30 days to respond, usually to an email, before removing the registration from its database and requiring submission of a new one. If the entity identified as U.S. agent declines the role, FDA will allow the facility to amend its registration. For renewals, if the U.S. agent has previously agreed to serve in that role, FDA will not “re-verify that the U.S. agent has agreed to serve as the U.S. agent for the foreign facility.”
FDA also posted a new flow chart detailing its exemption from food facility registration requirements for retail food facilities. The exemption applies if a facility’s “annual monetary value of sales of food products directly to consumers [is] greater than the annual monetary value of sales of food products to all other buyers (e.g., businesses).” A facility can be a retail food establishment “even if it manufactures, processes, packs, or holds food,” FDA said.