In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or ”cultured meat” as an alternative to farm-grown meat products. A product of either bulk cell culture or 3D scaffolded cell culture, cultured meat is made by growing animal-derived cells in an artificial environment, and triggering their differentiation into muscle cells in order to produce artificial muscle tissue that can then be harvested and eaten. Cultured meat supporters hope that, being actual muscle tissue, cultured meat will have superior flavor and texture to existing meat substitutes. While this technology is only now emerging from its initial proof-of-concept stages, the U.S. Food and Drug Administration is moving ahead proactively with plans to assess the safety of, and provide appropriate regulations for the commercial production of, this novel type of cultured food product.

On June 15, 2018, the FDA announced that it would hold a one-day public meeting to gather input on potential regulatory issues surrounding the safety of cultured meat products. The purpose of the meeting is to solicit public and stakeholder comments on potential safety issues that should be addressed in the process of formulating regulations for cultured meat products. While the FDA has promulgated regulations regarding the safe production and handling of bacteria-, algae-, and fungus-based foods and food ingredients, safety regulation associated with foods based on mammalian cell culture technology has not yet been addressed. By soliciting comments early from a variety of stakeholders, the FDA hopes to harness expertise and data from outside the agency. In turn, the FDA hopes that this approach will yield as comprehensive a basis as possible for considering how to most effectively ensure the safety of this unusual addition to the food supply.

Topics are expected to include starter cells, culture techniques and media, and manufacturing processes, as well as other areas of interest, such as labeling. The FDA has considerable expertise in regulating products derived from cell culture in the pharmaceutical and biologics spaces, as well as a longstanding history in regulating food production, handling, and packaging. However, the agency acknowledges that there are likely to be “unique attributes and challenges” specific to cultured meat that have not yet arisen elsewhere.

Notably, this type of meeting signals a willingness on the part of the FDA to engage with stakeholders and the public as a way of gathering data outside the agency before preparing draft guidelines. Engaging early in the development cycle provides a means for assessing reasonable regulatory frameworks without unduly hindering innovation in this emerging and evolving technology space. Significant challenges remain, and the promise of follow-on innovation from the development of cell culture on a previously unheard-of scale is enticing. Working to provide clarity on paths-to-market will point the way forward for companies seeking to bring cultured meat from lab to market. Public comments regarding the meeting and any suggested regulatory issues will be accepted until September 25, 2018. Information on how to attend the meeting can be found here.

Written by: Dan Yarbrough and Jane Dai, Ph.D