Previously on the blog, we noted that federal government agencies don’t always play well together. So, when these agencies synchronize their efforts, the industry would do well to take notice. One such coordination effort is well underway. The FDA and the USDA just announced that they will jointly oversee cell‑cultured food production derived from livestock and poultry.

The FDA and the USDA’s announcement follows the agencies’ October 2018 public meeting, where they met with consumers and members of the agricultural industry to discuss safety considerations, possible hazard controls, and labeling concerns related to cell‑cultured foods. Cell‑cultured food production is a burgeoning industry. It continues to raise questions about what will be regulated, what the regulatory process will look like, and which agencies will manage the regulatory process.

The joint‑regulatory framework proposed by the FDA and the USDA answers some of these questions. Under this framework, each agency’s authority follows the cell‑cultured food production process:

  1. First, the FDA will oversee the earlier stages of the production—namely, processes related to cell collection, cell banks, and cell growth and differentiation.
  2. Next, once the cells are ready for harvest, the FDA will hand the regulatory baton to the USDA.
  3. Finally, the USDA will oversee both the final stages of production and product labeling.

Although this framework clarifies some issues, outstanding questions remain. Notably, seafood was not mentioned in the agencies’ announcement. Currently, the FDA regulates seafood. However, it remains unclear whether the USDA will assume authority over the final stages of cell‑cultured seafood production. The agencies’ announcement also fails to detail how cell‑cultured food will be labeled. Food labeling continues to raise difficult issues; labeling for cell‑cultured food only makes the issue more difficult. The agencies have yet to tackle the issue.

The agencies have acknowledged that they are continuing to refine the technical details of their framework. To aid in that process, the agencies have encouraged interested parties to participate in the public comment period. The public comment period ends on December 26, 2018.

Given the regulatory uncertainties inherent in cell‑cultured food production, industry participants should expect further attention from federal enforcement agencies. If you have questions about the information discussed in this blog post, the Venable Team is here to help guide you through these complex issues.