Navigating the legal landscape of cell-cultivated meat in the U.S.

Public awareness surrounding cell-cultivated meat has grown within the United States at a fast pace since the U.S. Department of Agriculture (USDA) approved the sale of cell-cultivated chicken in 2023 for human food. Animal production, pet food and cell-cultivated meat industries looking toward the future have been left wondering whether it will become accepted in the pet food industry, if it’s a passing fad or somewhere between. For those in the United Kingdom it’s already here, as the UK became the first country in Europe to allow cell-cultivated meat to be used in pet food. Public opinion on something new, like cell-cultivated meat, can often make or break an industry’s success and largely depends on whether consumers (pet or human) not only enjoy the taste of it, but also whether consumers consider it “safe” to consume or feed to their pets. Food safety often, if not exclusively in some states, starts with the federal government.  

FDA, CVM and AFIC

The U.S. Food and Drug Administration (FDA) is responsible for ensuring food is not adulterated or misbranded and regulates food ingredients used during production of pet food products. The Federal Food, Drug and Cosmetic Act (FD&C Act) requires that all pet foods be safe for animals to eat, produced under sanitary conditions, contain no harmful substances and be truthfully labeled. 

At least as far back as 2019, USDA and FDA began outlining how the two departments would regulate food produced by animal cell culture technology made for human food. Under an agreement between the agencies, FDA is responsible for the pre-market consultation process and inspecting records at facilities and will continue to conduct routine inspections and oversight activities at cell banks and facilities where cells are cultured, differentiated and harvested. It is unclear how FDA intends to regulate food produced by animal cell culture technology made for pet food. And to date, there has not been market approval by FDA for utilizing cell-cultivated meat in pet food. Recent strides toward that goal have been completed, with CULT Food Science’s subsidiary, Further Foods, submitting a trial design protocol to FDA on August 8, 2024, concerning cell-cultivated chicken in dog food products. This trial is anticipated to occur in Q4 of 2024, if accepted by FDA.

If market approval arrives for pet food, it is likely that the Center for Veterinary Medicine (CVM) will continue its role in reviewing pre-market pet food ingredient submissions, which could include cell-cultivated meat. On August 8, 2024, FDA issued a statement indicating its intent to evaluate its animal Food Additive Petition (FAP) and Generally Recognized as Safe (GRAS) notification programs, with an eye on improving the path forward for pet food companies to introduce new pet food ingredients. This process will include consultations with those firms, potentially cell-cultivated meat companies, who develop pet food ingredients through the Animal Food Ingredient Consultation (AFIC) process. This AFIC process began after FDA’s Memorandum of Understanding expired with the Association of American Feed Control Officials (AAFCO) on October 1, 2024. However, state label registration requirements will continue. States often permit the use of an ingredient if it is published in the AAFCO Official Publication, and the ingredient is labeled using the term defined therein. To date, there are no cultivated meat definitions in AAFCO’s Official Publication.

Current state and legal challenges to limit cell cultivated meat; the forecast for cultivated meat in pet food

When new, novel products arrive on the marketplace, we often see an influx of litigation and state-by-state legislation tied to whether those products are marketed in a manner that is not deceiving to the consumer and/or contain products safe to consume. And as we have discussed, litigation that first infiltrates the human food industry often follow in the pet food industry

Despite its approval of the sale of cell-cultivated chicken from only two companies in 2023, USDA has since then remained silent on the approval of other meat products derived from cell-cultivated science to date for human food. But during 2024’s legislative session, states have seen a flurry of introduced bills that either seek to ban the sale and manufacture of cell-cultivated meat or implement labeling regulations about cell-cultivated meat. On May 1, 2024, Florida became the first state to ban the sale and manufacture of cell-cultivated meat, with its Senate Bill 1084. Under SB 1084, a knowing violation of the act is a misdemeanor of the second degree, and food establishments that manufacture, distribute or sell cultivated meat would be subject to criminal discipline. This ban arguably applies even if the cell-cultivated meat is intended for human or pet food, based on the current definition of “cultivated meat.”

Alabama became the second state to pass a similar bill, Senate Bill 23, which also prohibits the manufacture, sale or distribution of cell-cultivated food products in Alabama and provides criminal and administrative penalties for a violation of the act. The bill became effective October 1, 2024. Nebraska could be the third U.S. state to ban the sale of cell-cultivated food products. Recently, Governor Jim Pillen signed an Executive Order limiting the sale of such products and directing the Nebraska Department of Agriculture to commence its rulemaking process about the proper labeling and marketing of such products within Nebraska. Governor Pillen further intends to ensure strict guidelines are followed concerning whether state agencies and contractors may obtain cell-cultivated meat. Pillen further hinted that an outright sales ban is forthcoming.

Other states, such as Arizona, Tennessee, Kentucky, New Hampshire and West Virginia, have seen similar bills introduced in the 2024 legislative session, but the bills have either failed or stalled in committee. Arizona’s stalled bill, House Bill 2121, included legislative findings that regulating cell-cultivated meat is a matter of statewide concern necessary to protect public health and that the state’s cattle ranching industry is integral.

If not an outright targeted ban, additional labeling restrictions may also apply to cell-cultivated meat companies. Additional “truth in labeling” laws concerning what products may be labeled as “meat,” primarily in human food products, have passed in states including Missouri, Louisiana, Arkansas, Mississippi, Kentucky, South Dakota, Maine and Wyoming. Lawsuits challenging these laws have varied in success. Building on the plant-based meat pushback, and likely given the USDA and FDA’s approval of cultivated meat in 2023, additional states have now passed or proposed bills this legislative term specifying what can be labeled as “meat,” specifically addressing cultivated meat products.

For example, Iowa passed the Iowa Meat Integrity Act, creating labeling requirements for what it ultimately defined as “manufactured-protein food products.” The law goes beyond just cell-cultivated meat, however, and imposes labeling requirements on insect-protein food products and plant-protein food products. Specifically, Iowa’s law prohibits the use of an “identifying meat term” (e.g. chicken, pork, beef, veal or burgers) on the food packaging unless a “qualifying term” is within close proximity on the package that ultimately discloses to the consumer that the food product is not a meat product (e.g. cell-cultured, lab-grown, plant-based, vegan or imitation).

Given that FDA and USDA have permitted the sale of cultivated chicken by two companies for human food, it should come as no surprise that Florida’s ban on the manufacture and sale of the meat spawned a lawsuit by one of the manufacturers of cell-cultivated meat. For those states that choose to allow the sale of cell-cultivated meat, the 43 companies within the U.S. alone that are involved in the cell-cultivated meat industry may be at risk of the consumer skepticism that often results in litigation tied to false advertising claims, or may risk criminal penalties for misrepresenting that the food product is “meat.”

If the approval of cell-cultivated meat is on the horizon for the pet food industry, those industry stakeholders should keep a watchful eye on the state legislation that may narrowly define how they market such products — or even if they may market, manufacture or sell those products. 

Briefly: Top 5 takeaways

  1. Animal production, pet food and cell-cultivated meat industries have been left wondering whether it will become accepted in the pet food industry.
  2. At least as far back as 2019, USDA and FDA began outlining how they would regulate food produced by animal cell culture technology made for human food.  
  3. When novel products hit the marketplace, we often see an influx of litigation and legislation tied to whether those products are marketed in a manner that is not deceiving and/or contain safe products.
  4. During 2024, states have seen a flurry of introduced bills that either seek to ban the sale and manufacture of cell-cultivated meat or implement labeling regulations about cell-cultivated meat.
  5. Industry stakeholders should keep an eye on state legislation that may narrowly define how they market cell-cultivated meat products — or even if they may market, manufacture or sell those products.  

Leave a Comment