Introduction: Meat Alternatives and Cultured Meat

Conventional meat production has been implicated in environmental damage, the rise of antibiotic resistant bacteria, and increasing emission of greenhouse gasses. Additionally, some have raised concerns about conditions under which animals are kept and harvested for large scale traditional meat production. At least two possible solutions have been proposed, and are being developed, to address one or more of these concerns.

The first solution involves plant-based meats and related products. Examples of these include Impossible Foods' plant-based meat products. An alternative solution is lab grown meat. Lab grown meats are cultured meats. Cultured meats are made from animal cells. The animal cells are grown using familiar nutrients such as amino acids and fats and vitamins. Cultured meats can have several advantages including: efficiency in meat generation, economy of resources—including growing just the edible portion of the meat, non-use of antibiotics, and that the cultured meat tastes more like traditional meat. An example of a cultured meat producer is Eat Just, Inc.

Earlier, we wrote about the U.S. Food and Drug Administration's (FDA's) Proposed Food Standard Principles, and how these can determine, for example, if plant-based or cultured meat can be called meat. This is very important, because being excluded, for example, from the meat food category can significantly negatively impact emerging food products like plant-based and cultured meats. Thus, developers and manufacturers of these alternative-to-traditional-meat products are carefully following developments in this area in the United States and around the world.

In a Regulatory First, the SFA Approves Eat Just's Cultured Chicken

That is why the following development is noteworthy: recently, the Singapore Food Agency (SFA) granted Eat Just approval to begin selling its lab grown, cultured chicken as a food ingredient in Singapore. According to news reports, the cultured chicken will initially be sold in a single restaurant, with an intermediate scaling to about 15 restaurants planned in the near future. Eventually, Eat Just plans on moving into retail.

The approval raises several considerations associated with cultured meat. First is the ability to scale production to meet and create demand. Next is price, which like many manufactured products, drops with increased economy of manufacturing scale. Another consideration is winning consumer trust for the recently approved cultured chicken. A further consideration is forming appropriate partnerships to manufacture the cultured chicken locally. Finally, the SFA has agreed to allow the product to be labeled as cultured chicken, which is very important because it places the product into the meat category.

Eat Just and other producers of alternative meat products hope that the SFA's approval will positively influence regulators in the United States and Europe. For example, in the U.S., the FDA and the U.S. Department of Agriculture (USDA) jointly regulate certain cultured meats. One contravening force to rapid U.S. approval may be traditional meat producers, such as the U.S. Poultry & Egg Association and the National Cattlemen's Beef Association, who may vigorously oppose any U.S. approval of cultured meats, or allowing such products to be labeled or classified as meat products.

Regulatory Pathway for Cultured Meat Approval in the United States

In the United States, under a formal agreement, the FDA and the USDA will jointly regulate cultured meats. Cultured meats are produced by a process that initially involves growing animal cells in the presence of nutrients such as amino acids and fats. Under the formal agreement, or joint regulatory framework, the FDA will regulate earlier steps in the cultured meat manufacturing process including:

• Cell Collection;
• Cell Banks;
• Cell Growth or Proliferation; and
• Cell Differentiation.

The FDA will also ensure compliance with "Current Good Manufacturing Practices and preventive controls regulation, and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food." Further, the FDA will "conduct appropriate inspections" and take "enforcement action if necessary …"

Between cell differentiation and cell harvest, a transition or regulatory "handoff" will occur from the FDA to the USDA, specifically USDA's Food Safety and Inspection Service (FSIS). As part of that transition, the FDA will provide the information necessary for the USDA to "determine whether harvested cells are eligible to be processed into meat or poultry products that will bear the USDA mark of inspection."

As described in a joint announcement and the formal agreement, after the transition, the FSIS will oversee "the production and labeling of human food products derived from the cells of livestock and poultry," which includes "inspections" and "enforcement action if necessary …" The FDA and the FSIS jointly held a public meeting on cultured meat regulation, which was recorded, and is available here.

Patenting Cultured Meat Products and Processes

A further and important consideration for cultured meat manufacturers involves patenting the cultured meat products, and processes for making and using these products. Patenting can provide, on a country-by-country basis, significant commercial and market advantages. Also, before going to market in any nation or territory, understanding the cultured meat patent landscape is highly recommended.

Trademarks

Trademarks can help differentiate a brand in a growing and competitive marketplace. Careful consideration should be given to a worldwide trademark strategy for protecting cultured meat company names and products.

Conclusion

The SFA's approval of Eat Just's cultured chicken is an exciting development in this emerging field.