There are three basic areas of regulation pertinent to food products in the United States: ingredient approval; food safety; and labeling. As a general rule, new food ingredients must meet FDA’s food additive approval requirements under the FD&C Act before they can enter the marketplace. A proponent of a new food ingredient must demonstrate the ingredient is either “generally recognized as safe” or the ingredient must be the subject of a successful food additive petition before it can be used in food products. If a new ingredient is deemed safe by FDA and its use is proposed for meat and poultry products, FSIS will evaluate whether the ingredient is suitable for meat and poultry products, i.e., it is used at the minimal level necessary to achieve its proposed use.

In contrast, the regulatory approaches to ensure food is produced safely and labeled appropriately differ substantially depending on the regulated products. Most meat and poultry products are produced under continuous inspection by FSIS personnel, whereas most FDA-inspected plants can go weeks or months without encountering a government inspector. Moreover, FSIS-inspected products must clear USDA’s label approval process before products can enter the marketplace; FDA-inspected products are subject to misbranding regulations, but do not need to receive regulatory label approval before the products can enter commerce. Under the present system, USDA-inspected products typically face higher regulatory costs and burdens.

With the varying regulatory costs in mind, opponents and proponents of cell-based meat have different ideas on how these products should be regulated. For instance, in February, the U.S. Cattlemen’s Association (USCA) submitted a petition to FSIS requesting the agency establish a standard of identity for “beef” that would limit beef to flesh derived from cattle born, raised and slaughtered in the conventional sense. Under this approach, cell-based meat produced from bovine cells could not be sold as “beef” and would have to bear a different product name. Although several trade groups share USCA’s concerns about cell-based meat being confused with conventional proteins, numerous associations opposed the petition because it could provide a basis for FDA to claim sole authority for regulating lab-grown meats. This could result in similar products with similar food safety concerns being regulated under separate systems. 

Another approach was suggested in an Aug. 23 letter to the White House by North American Meat Institute and Memphis Meats, one of the leading cell-based meat startups. In the letter, they encouraged the Trump Administration to develop a clear regulatory approach to accommodate the commercial introduction of cell-based meat and poultry. They also suggested a split approach to regulating cell-based products that plays to each agency’s strength. In particular, they suggested FDA should be responsible for pre-market safety evaluations, whereas FSIS should have jurisdiction to ensure cell-based products are not adulterated or misbranded when they enter commerce.

At this point, it is not clear which agency will take the lead in regulating cell-based meat and poultry. Not only does this topic generate disunity amongst trade associations, it has also led to some open squabbling between FDA and USDA. FDA has been proactive in doing industry outreach to generate discussion on potential plans for safety oversight on cell-based meat and poultry. The agency has touted its familiarity with the relevant technologies based on its oversight of other tissue-based products, such as replacement skin produced from stem cells. However, USDA has registered numerous protests that it should have a seat at the table of any discussions regarding the regulation of cell-based meat and poultry.

It’s difficult to predict what regulatory framework will emerge to accommodate the commercial introduction of lab-grown meats. It is quite possible that FDA and FSIS may divvy up responsibility with a collaborative approach. One thing is for sure: This topic will generate discussion for years to come.  NP