The Food and Drug Administration (FDA) held a public meeting July 12 on “Foods Produced Using Animal Cell Culture Technology” to give the public an opportunity to provide comments on federal regulation of the future production of foods using animal cell culture technology. While a thorough account of the all-day meeting is beyond the scope of this article, we wanted to share with you our main takeaways from the meeting, which can be lumped into three categories: jurisdiction, regulatory oversight, and labeling.
- Jurisdiction. FDA reasserted that it has sole jurisdiction in this area, despite competing claims by the USDA/FSIS and various meat industry organizations. To support such an assertion, FDA highlighted its years of experience with “biological productions systems” and existing procedural mechanisms designed to effectively oversee food produced using cell-cultured technology.
- Regulatory Oversight. Issues and perspectives involving regulatory oversight dominated the discussion. FDA’s basic message was that it is open to using its existing authorities in new or modified ways in order to address the novel issues posed by the technology and that it wants to continue to work with various interests to design and implement just such a process. Views expressed by commenters on these questions were predictably diverse. Proponents of the technology articulated a need for some perfect balance between the review and oversight processes that is not overly burdensome but still conveys some form of government acceptance and approval for public consumption. What could be characterized as traditional consumer interests tended toward extreme caution and the need for extensive premarket research, citing the precautionary principle. But there were other interests, more hostile to traditional animal agriculture, whose proponents would like to see such products become available to the public as quickly as possible.
- Labeling. Finished product labeling received virtually no attention from FDA during its presentation but the topic did come up in the comment process. One representative from a livestock organization was adamant that any such products should not be associated with traditional terms such as “meat” and “beef.” A dairy representative also took advantage of the opportunity to criticize FDA for its ongoing tolerance for the use of labeling terms such as soy and almond “milk.”
In addition to hosting a public meeting, FDA is also accepting written comments on this topic (Docket No. FDA-2018-N-2155). Comments are due September 25, 2018.
If you have any questions or would like assistance in drafting comments or more information on the issues discussed in this blog, please contact the author.