FDA and USDA’s plan to jointly regulate lab-made meat raises new questions for the future of food regulation.
The sale of lab-grown meat—also called cell-cultured meat, in vitro meat, synthetic meat, fake meat, and “clean” meat—raises two main regulatory issues: How will regulators ensure the safety of this food? And who will oversee the labeling of these products?
After a joint public meeting last fall on the topic of meat made in the lab, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) released a statement announcing that they will be working together to regulate lab-grown meat as the agencies adapt to new technology that challenges existing regulatory schemes.
Cell-cultured meat does not fit neatly into the current framework of either FDA or USDA, as it possesses characteristics that fall within the jurisdiction of both agencies. Since it originates from livestock and would likely be sold alongside traditional meat products in grocery stores, cultured meat appears to fall within USDA’s jurisdiction. But the process of growing it in a lab involves techniques FDA currently regulates as part of its oversight of other food and drug products.
Scientists start the process of developing cultured meat by collecting samples of muscle cells from livestock or poultry. When scientists aim to make a burger, the sample comes from a cow; however, other animals such as chickens and pigs could also be used. Scientists then grow the cells in an artificial environment that offers the necessary nutrients for the cells to multiply and develop into muscle tissue. The resulting product looks like any ground beef patty found in a local grocery store.
Going forward, FDA and USDA will develop a joint regulatory framework that combines the expertise of the two agencies. The joint statement explains that FDA will oversee the parts of meat production that directly involve culturing the cells, since FDA already regulates cell culture systems as a part of its role in ensuring the safety of drug products. USDA will oversee the collection of cell samples as well as the final stages of food production and labeling.
This decision ended an ongoing debate in which stakeholders from the livestock industry and advocates for cultured meat had been arguing for opposite agencies to regulate the product. But it marks the beginning of a new debate about the details of the joint regulatory framework, with the definition of “meat” at the heart of this debate.
Although the joint press release from USDA and FDA did not explicitly designate cultured meat as a “meat food product” within the definition of the statute that gives USDA regulatory authority, the fact that USDA will oversee production and labeling has led some commentators to conclude that the agencies do consider cultured meat to be within USDA’s jurisdiction.
The inclusion of USDA in the regulatory process has reportedly pleased many groups in the traditional meat production industry who argued that cultured meat companies would have an unfair advantage if FDA had sole regulatory authority over their products. In part because FDA’s regulatory framework for food presumes it is safe until proven otherwise, FDA only periodically inspects the facilities it regulates. USDA, on the other hand, has inspectors in its regulated facilities during all hours of operation. For this reason, cultured meat producers under the joint framework will likely face more inspections than if FDA were the sole regulator.
USDA involvement with cultured meat labeling, however, leaves open the question of whether the term “meat” will appear on these products when they come to market.
One group from the traditional meat production industry, the United States Cattlemen’s Association, petitioned USDA in early 2018, requesting that the agency define “meat” narrowly to prevent products from being labeled as such unless they came from the carcass of an animal. The Association argued that consumers could be misled by cultured and plant based meat products labeled with the term “meat.”
Advocates for cultured meat products, such as the Good Food Institute, argue that consumers need to know that products are derived from animal cells so that they can know about any potential allergy issues that they could have with the products. The Institute also notes that far from being misled, most consumers who would buy these products would do so intentionally, so it would not be in the interest of cultured meat producers to confuse consumers.
Thus far, FDA and USDA have not released a labeling scheme for cultured meat, so the question of labeling will likely continue stir controversy as these products move to market in the coming years.
Although in 2013 it cost $330,000 to make one lab-grown burger, at present that cost has reportedly dropped to $600 for a quarter pounder. Companies have reportedly said that they hope to have that number down to $5 or less within a few years. It may not be long until consumers get a chance to judge lab-grown burgers for themselves.