Tag:regulatory

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Breakthrough FDA Decision: Agency Completes Its First Pre-Market Consultation for Human Food Made From Cultured Animal Cells
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Mandatory Bioengineered Food Labeling Rule Went Into Effect on January 1, 2022 – Are You Ready?

Breakthrough FDA Decision: Agency Completes Its First Pre-Market Consultation for Human Food Made From Cultured Animal Cells

By: Natalie Rainer, Alexa Sengupta

On 16 November 2022, the U.S. Food and Drug Administration (FDA) announced that it had completed its first pre-market consultation for “human food made from cultured cells,” also known as “cell-based” foods.[1] “Human food made from cultured animal cells” refers to growing animal cells  in a controlled environment to produce food without sacrificing animals.[2] 

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Mandatory Bioengineered Food Labeling Rule Went Into Effect on January 1, 2022 – Are You Ready?

By: Amy Wong

Summary: In 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) implemented the National Bioengineered Food Disclosure Standard (NBFDS). While some food companies have voluntarily complied with the NBFDS since 2018, the new regulations make compliance mandatory as of January 1, 2022.

Key Takeaway: The NBFDS is an extensive marketing standard with which every regulated entity should become familiar.  While the USDA does not have authority to issue a recall or impose civil penalties for violations of the NBFDS, the AMS could initiate an investigation and publicly publish the findings of its investigation.  It is also possible that States will adopt the same or similar requirements and impose remedies for violations of their standards, such as damages, penalties, injunctive relief, and attorney’s fees.

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