Major milestone for human food made with cultivated animal cells in the United States
25 November 2022
Vladas Činga, Regulatory Affairs Manager
What has been announced?
On the 16 of November, the
that it has completed its first pre-market consultation for a human food from cultivated animal cells. The product, by UPSIDE Foods, is made
from sheets of cells from chicken muscle and connective tissues.
The information on this cultivated animal cell food product and its associated production process was submitted to
After consultation the FDA issued an official response letter to UPSIDE Foods stating that, based on the information
presented, as well as other information available to the agency, they did not identify a basis for concluding that the production process as
described would be expected to result in food that bears or contains any substance or microorganism that would adulterate the food.
It also stated that they have no questions at this time regarding UPSIDE Foods’ conclusion that foods comprised of
or containing cultured chicken cell material resulting from the production process as described are as safe as comparable foods produced by
What does this mean? What other considerations are there?
While this is a significant step forward for cultivated animal cell products in the United States, before putting the
product on the market, the company must ensure that foods it markets are safe, wholesome and in compliance with all other applicable legal
and regulatory requirements, including labelling and inspection requirements
administered by the Food Safety and Inspection Service
within the U.S. Department of Agriculture (USDA-FSIS). Although current USDA-FSIS regulations requiring sanitation and HACCP systems are
immediately applicable, requirements for the labelling of products from cultivated cells of livestock or poultry are not yet available from
Yet here we finally see in practice what data was deemed necessary by the FDA to successfully conclude the consultation for this
type of product
Nonetheless, this announcement is very important. Guidance documents on data requirements for cultivated animal cell
product approvals are still scarce globally, with the
to publish draft industry guidance on premarket consultation on cultured animal cell foods by December 2022. Yet here we finally see in
practice what data was deemed necessary by the FDA to successfully conclude the consultation for this type of product.
The creation of a new inventory for human food made with cultured animal cells signals that the FDA is confident to
have found a pathway to legally place cultivated animal cell food products onto the U.S. market for human consumption, and expects or has
already started other consultations. Tens of companies in the cultivated animal cell food space are racing to be the first to put their
product onto the U.S. market at scale and, most importantly, at a competitive price.
What support can Campden BRI offer businesses?
With our in-depth knowledge of legislation surrounding “novel” foods, Campden BRI is well positioned to assist
companies with gap analyses, risk assessments and dossier preparations, for markets such as the U.S., EU, UK, Singapore,
Australia/New Zealand and others.
How can we help you?
If you’d like to find out more about legislation around novel foods, contact our support team to find
out how we can help.
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