Today, the U.S. Food and Drug Administration issued two guidance documents to help food facilities meet their registration requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act).
One of the documents being published today is the seventh edition of a guidance to help the owners and operators of facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States understand the registration requirements. Previous iterations of this guidance were released following the adoption in 2002 of amendments to the FD&C Act that required food facility registration.
The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act, and in 2016 FDA issued a final rule on the amendments to registration of food facilities (Registration Final Rule) to reflect these changes. The seventh edition of the guidance builds on the previous edition of the guidance to include questions and answers on the Registration Final Rule, among other registration-related topics.
FDA also released a supplemental draft guidance to the seventh edition which includes questions and answers that clarify our thinking about the registration requirements in situations in which multiple entities are involved in the use of shared physical space. These situations include when manufacturers lease their facility, store food at self-storage warehouses, or use commercial communal kitchens that are also used by other manufacturers to process food. FDA intends to incorporate the questions and answers in this supplemental draft guidance into future editions of the food facility registration guidance.
In addition to these documents the FDA also released a small entity compliance guidance in May 2018 to help smaller facilities understand and meet their registration requirements under the FD&C Act.
As a reminder, the 2018 biennial registration renewal period begins October 1st and concludes December 31st.