Well Done


The US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) issued a joint statement on November 16 indicating that both FDA and USDA will jointly oversee the production of cell-based food products derived from livestock and poultry. The proposed regulatory framework generally involves the FDA overseeing cell collection, cell banks, and cell growth/differentiation, and USDA overseeing the production and labeling of the food products following cell harvest. While it is encouraging to see the agencies working together to resolve this threshold question, it simply sets the stage for further evaluation of any number of challenging questions.

FDA Oversight

As laid out in the proposed regulatory framework, FDA is proposing to oversee cell collection, cell banks, and cell growth/differentiation for cell-based food products. Such approach is said to be consistent with FDA’s historical experience regulating cell-culture technology and living biosystems, both of which were discussed at length during FDA’s July Public Meeting on Foods Produced Using Animal Cell Culture Technology. However, here is where details matter and issues could potentially arise:

  • Will prior evaluations of the cell collection process, cell banks, and techniques for cell growth/differentiation be required prior to federal acceptance?
  • If FDA is leveraging its experience with cell-culture technology and living biosystems, which particular review or notification procedures in place will apply (e.g., Generally Recognized As Safe (GRAS) notifications, Food Contact Substance (FCS) notifications), or will new ones have to be created in this area, such as the cell-based food equivalent of FDA’s Plant Biotechnology Consultation Program?
  • If the existing GRAS notification procedure is the presumed vehicle, is the current publicly available scientific information for these products sufficient to establish a general recognition by qualified experts of its safety? If not, what alternatives can be made available?

USDA Oversight

Issues involving federal preemption of labeling have, at least for the moment, been answered, with the announcement that USDA will be overseeing production and labeling for cell-based meat and poultry products. Both the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) explicitly preempt state laws regulating labeling of meat and poultry products by providing that “marking, labeling, packaging, or ingredient requirements, in addition to, or different than, those made under [FMIA or PPIA] may not be imposed by any State.”[1] We can expect USDA’s positioning here to impact any current or future attempts by states to regulate cell-based meat and poultry products. However, USDA’s oversight, as proposed, raises the following questions:

  • Does USDA have the expertise to ensure proper oversight of cell-based food production following cell harvesting?
  • Will USDA’s New Technology notification procedure be modified to reflect cell-based food technology? Or will some new process need to be developed?

Lastly, one of the biggest questions that last week’s announcement did not directly address: Where do cell-based seafood products fit into the proposed regulatory framework? FDA currently has regulatory oversight over fish and fish products pursuant to 21 CFR Part 123. Therefore, how will FDA and USDA reconcile this jurisdictional split? Will dual systems of oversight be compatible?

Again, it is encouraging to see both agencies working together in an attempt to provide clarity to an emerging industry, but inevitably, as some questions get answered, others will emerge. In many ways this is where the tougher questions of science and public policy will come into focus, and where the real work begins.

[1] 21 U.S.C. § 678 (meat); 21 U.S.C. § 467e (poultry).