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Hello New Harvest,
You may have seen the recent and encouraging news: that the FDA has completed its first “pre-market consultation for a human food made from cultured animal cells” for UPSIDE Foods.
As scientists and safety professionals, this means we are on the right path to getting a product to market. But let’s not get distracted by the headlines: this product has not been approved for sale. It has only completed FDA’s pre-market consultation. This process is still a work in progress since the product and manufacturing facilities need an inspection granted by the USDA-FSIS.
In short, this is the first green light on a longer road ahead.
There has been a lot of speculation about this being “an approval,” or if it followed the GRAS mechanism. However, this is a novel situation, and we want to take time to understand how it was done so we can provide a more insightful breakdown of the kinds of data and mechanisms involved, and their implications for the cultured meat ecosystem.
In meantime, Vince Sewalt, New Harvest Board member and an esteemed regulatory expert has written an informative post explaining some of the nuances of this story.
This is a new and exciting milestone - but just the beginning. We must remember that there is still important open research that needs to be conducted. New Harvest is focusing on this exact goal with the safety initiative. The more public data is available for regulators, the better we can ensure that cultured meat achieves its mission: to be better for people, animals, and the planet.
Looking forward to sharing more updates about this milestone!
 
Dr. Yadira Tejeda-Saldana & Dr. Dwayne Holmes
Directors of Responsible Resarch & Innovation, Canada & EU, respectively
New Harvest
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November 17, 2022View this email in your browser
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