Search results for: cultivate

  • Last week Florida Governor Ron DeSantis signed SB 1084 into law, making it “unlawful for any person to manufacture for sale, sell, hold, or offer for sale, or distribute cultivated meat in this state [Florida].” “Cultivated meat” is defined as “any meat or food product produced from cultured animal cells.” We note that this ban does not extend to plant-based meat imitation products.
  • Knowing violation of the law is a second-degree misdemeanor and the law provides for other punishments for businesses, including license suspension. The governor’s webpage indicates that the law represents Florida “fighting back against the global elite’s plan to force the world to eat meat grown in a petri dish or bugs to achieve their authoritarian goal.” The governor’s webpage links to another webpage by the World Economic Forum which touts the potential benefits of insect protein, but the law doesn’t ban insect protein, so it’s not clear why insect protein is mentioned.
  • The law is the first of its sort, but Alabama, Arizona, and Tennessee have considered similar laws. Like California’s recent food additive ban (AB-418), the law raises interesting questions about the authority of states to pass such bans, including questions  related to preemption and the (dormant) commerce clause.
  • Florida Governor Ron DeSantis expressed his support of two bills in the Florida Legislature that would ban the cultivation and sale of lab-grown (cultivated) meat products. He said in a public statement that the bills will “protect our meat . . . We are going to have meat in Florida. We are not going to do that fake meat.”
  • House Bill 435 and Senate Bill 586  would prohibit the manufacture and distribution of cultivated meat in the state and establish criminal penalties for doing so. The bills define “cultivated meat” as “any meat or food product produced from cultured animal cells.” Violating the ban results in a second-degree misdemeanor, and a restaurant, store, or other business could have its license suspended for selling cultivated meat products. In addition, food establishments that distribute or sell cultivated meat would be subject to fines and revocation or suspension of the establishment’s permit. Products in violation of the ban would be subject to an immediate stop-sale order.
  • Both bills were filed in November 2023. The House bill was found favorable by the Agriculture, Conservation & Resiliency Subcommittee and is now in the Agriculture & Natural Resource Appropriations Subcommittee. The Senate bill has been introduced in the Agriculture, Commerce and Tourism, and Fiscal Policy committees.
  • With these bills, Florida joins several other states, including Arizona and Texas, in moving toward banning lab-grown (cultivated) meat products. Keller and Heckman will continue to monitor and report on legislation related to cultivated meat.
  • Although some consider the Netherlands to be the birthplace of cultivated meat, cultivated meat has not yet received pre-market approval in the European Union (EU).  Nevertheless, the Netherlands has forged ahead and announced that cultivated meat and seafood can be taste tested subject to the conditions set forth in the Code of Practice for Safely Conducting Tastings of Cultivated Foods Prior to EU Approval (Code of Practice). The Code of Practice is modeled after the principles used by the European Food Safety Authority (EFSA), although the review process is less extensive.  The proposed tastings will be evaluated by a panel of four experts who will conclude the tasting is either is “safe under the proposed conditions of tasting” and can proceed or “not safe under the proposed conditions of tasting” and cannot proceed. Information that must be submitted includes a description of the cultured cells, a description of the production process including all constituents of the growth media, safety information for all constituents, and an exposure assessment for all constituents. 
  • The Code of Practice also includes requirements regarding participants, procedures for the tasting, and limits testing to those conducting business in the Netherlands.
  • The United States and Singapore are currently the only countries where cell-cultivated meat products have received clearance for marketing.  For recent developments in the United States, see our previous articles on GOOD Meat’s label approval and USDA’s Directive to Inspection Program Personnel as Cell-Cultured Meats Begin to Enter the U.S. Market.
  • Keller and Heckman will continue to monitor and report on regulatory developments of cell-cultivated meat.
  • On June 8, 2023, GOOD Meat, the cultivated meat division of food technology company Eat Just Inc., became the first company to receive label approval from the U.S. Department of Agriculture (USDA) for its cultivated meat.
  • The label will use the term “cell-cultivated” although GOOD Meat and others in the industry prefer the term “cultivated” which we have previously discussed.
  • FDA and USDA share regulatory jurisdiction over cell-cultivated meats as detailed in a 2019 memorandum of understanding between the agencies. Following a voluntary pre-market consultation evaluating GOOD Meat’s production process, FDA issued GOOD Meat a “No Questions Letter.”
  • The next and final step in the regulatory review process before GOOD Meat’s cultivated chicken can go to market in the United States is for the company to receive grants of inspection from the USDA for the firm’s plant in Alameda, California, and its contract manufacturing partner, JOINN Biologics in Richmond, California.
  • GOOD Meat had previously obtained regulatory approvals for its cell-cultivated chicken in Singapore.
  • On June 14, 2023, Upside Foods became the second company to receive regulatory approval from the USDA for its label on cell-cultivated chicken. In November 2022, FDA completed the first pre-market consultation for human food made from cultured animal cells for Upside Foods, which was the first company to receive a “No Question Letter” from FDA.
  • Keller and Heckman will continue to monitor and report on regulatory developments of cell-cultivated meat.
  •  Thirty-six leaders in the cellular agriculture industry in the Asian region signed a memorandum of understanding (MOU) agreeing to the use of the English language term “cultivated” to describe animal products grown from animal cells. Many other terms including “cultured,” lab-grown,” and “cell-based” have also been used to describe such products. The MOU was announced at Singapore’s International Agri-Food Week (SIAW) at the end of last month.
  • The MOU does not have the force of law and could be impacted by future national laws and regulations but does reflect agreement from regional industry leaders that the term “cultivated” should be used because it is a scientifically accurate term that distinguishes from traditional animal products and it elicits the most positive responses from consumers. The MOU indicates that more research is needed to determine how to translate the term into various Asian languages.
  • It is unclear whether this agreement will have any impact in the U.S., but it is noteworthy that some signatories, including Cargill, have an international presence. There are no commercially available “cultivated” animal-based products in the US, but in 2019 FDA and USDA signed a MOU regarding their respective jurisdiction over cultivated meat and poultry products (the MOU did not use the term “cultivated”). Per the agreement, FDA will regulate the early stages of development while USDA will regulate post-harvesting steps, including labeling. FDA has exclusive jurisdiction over cultivated seafood products, although the agencies have indicated that they will work jointly to ensure consistent labeling. In that regard, in 2021 USDA issued an advanced notice of proposed rulemaking (ANPR) on labeling of cultivated meat and poultry products (the ANPR used the term “cultured”), but no regulatory action appears to be forthcoming. Similarly, in 2021 FDA issued a request for information (RFI) regarding cultivated seafood (the RFI also used the term “cultured”), but the agency has also not yet taken any regulatory action.
  • We also note that several states have tried to enact bans on the use of animal-based terms (e.g., meat) on products that are not derived from animals (cultivated meat products and plant-based meat products), although courts have found such bans to be unconstitutional. See e.g., Enforcement of Arkansas Law Enjoined. We will continue to monitor and repot on any developments in the commercialization and regulation of cultivated animal products.
  • French start-up, Gourmey, has submitted the EU’s first application for novel food approval of a cultivated meat product, duck foie gras, which it is offering in both a pâté “semi-cuit” form and as whole pieces ready for frying.
  • The European Commission (EC) will review before asking the European Food Safety Authority (EFSA) for a risk assessment, which the agency will start after verifying that the application contains all the required studies to prove that the product is safe for consumers to eat.
  • While the application should theoretically take about 18 months to review, it will most likely exceed this timeframe, as it is the first cultivated meat product application.
  • An EFSA approval may be controversial.  Italy in particular is opposed to cultivated meat and, in December 2023, banned lab-grown food from the Italian market.  The ban is arguably in breach of European law, since the Meloni government failed to respect EU standstill procedures, adopting the Italian bill before the end of the mandatory comment period, when a measure should be put on hold to allow other EU member states or EC to raise concerns.
  • If the Gourmey foie gras – or any other cultivated meat or fish – is authorized at EU level under the novel foods regulation, the decision will be binding on Italy and the government will have to allow the product on the Italian market.
  • UPSIDE Foods (UPSIDE), a cultivated meat company, has sued the state of Florida over the state’s ban (SB 1084) on the sale and manufacturing of “cultivated” meat.  The complaint, filed by the Institute for Justice (IJ), contends that the law violates a constitutional prohibition on favoring in-state businesses over out-of-state competitors. 
  • “If some Floridians don’t like the idea of eating cultivated chicken, there’s a simple solution: Don’t eat it,” said Paul Sherman, a senior attorney at IJ. “The government has no right to tell consumers who want to try cultivated meat that they’re not allowed to.  This law is not about safety; it’s about stifling innovation and protecting entrenched interests at the expense of consumer choice.”
  • The complaint reports UPSIDE’s chicken has been given the green light by both the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA), “affirming its safety and quality.  And because it is cultivated in a controlled environment, the process can potentially reduce the risk of foodborne illnesses, contaminations, and other issues in modern animal agriculture.”
  • Florida lawmakers in the past have called cultivated products a threat to their state’s agriculture industries.  Agriculture Commissioner Wilton Simpson, a key supporter of the law, called the lawsuit “ridiculous” and said “lab-grown ‘meat’ is not proven to be safe enough for consumers,” despite FDA and USDA authorization.
  • In 2024, four states (Alabama, Arizona, Florida and Tennessee) have considered legislation that would ban the manufacture, sale, or distribution of cell cultured meat.  Florida and Alabama signed their respective bills into law.   
  • Keller and Heckman will continue to monitor and relay any updates in this litigation.
  • On May 15, 2024, Iowa Governor Kim Reynolds signed the Iowa Meat Integrity Bill (SF 2391) to require specific labels for cell-cultivated, plant-based, and insect-based meat and egg alternatives, as well as prevent products deemed misbranded under the law from being sold to supplemental nutrition programs and schools. This follows bans on cell-cultivated meat in Alabama and Florida and moves by other states and Congress to restrict lab-grown meat sales, which we have previously blogged about.
  • Under the Iowa bill, a “manufactured-protein food product” will be deemed misbranded if the label does not contain a “conspicuous and prominent qualifying term in close proximity to an identifying meat term.” A “qualifying term” is defined as “a word, compound word, or phrase that would clearly disclose to a reasonable purchaser of meat products from a food processing plant that a food product is not a meat product” and includes words such as cell-cultivated, cell-cultured, fake, grown in a lab, imitation, insect, insect-based, insect-protein, lab-created, lab-grown, meat free, meatless, plant, plant-based, vegan, vegetable, vegetarian, or veggie.
  • The bill will require regulatory authorities to inspect food processing plants and grocery stores for compliance and allow them to issue a stop order or embargo order for violations.
  • The bill was led by Iowa Senator Dawn Driscoll and Representative Heather Hora, who said that “[l]ab-grown products are not the same as the high-quality meat raised by Iowa farm families.” According to the governor, the bill “prohibits companies from exploiting the trust consumers have with our livestock producers and misleading the consumers into buying products they don’t want.” While some legislators warned that the law could lead to national brands being unavailable to Iowa consumers, proponents argued that most major brands’ packaging is already within the bounds of the new law.
  • The bill goes into effect July 1, 2024.
  • On May 7, 2024, Alabama Governor Ivey signed SB 23 which bans the sale of cultivated meat in the state.  Specifically, the law will make it “unlawful for any person to manufacture, sell, hold or offer for sale, or distribute any cultivated food product” in the state.
  • The bill defines “cultivated food product” as “any food product produced from cultured animal cells.”  A violation of the ban by food sales establishments may result in civil penalties, or disciplinary actions, such as suspension or revocation of their food safety permits.  Violations are considered a Class C misdemeanor.  However, the bill does allow state research and development on cultivated products to continue.  The act will become effective October 1, 2024.
  • Alabama is now the second state in the US to sign this sort of ban into law.  As we previously reported, Florida Governor DeSantis signed SB 1084 on May 1, 2024, banning the sale of “cultivated meat.”
  • Keller and Heckman will continue to monitor and relay any developments in the cultivated food space.
  • On January 30, 2024, the Fair and Accurate Ingredient Representation on Labels Act (“FAIR Act“) was introduced in the House and Senate. The FAIR Act calls for new labeling requirements for cell-cultured meat and plant-based meat alternative (PBMA) products, including use of terms like “imitation” and “cell-cultured” on labels.
  • The measure addresses PBMAs in the following ways:
    • Defines “imitation meat/poultry” as any food that “uses a market name, descriptors, or iconography for, or is otherwise represented as meat or poultry; is manufactured to appear as a meat or poultry; or approximates the aesthetic qualities (primarily texture, flavor, and appearance) or chemical characteristics of specific types of meat or poultry – but does not contain any meat or poultry.”
    • Requires that products be designated as either “imitation,” or some other descriptive term, such as “black bean burger” or “meatless chicken tenders.”
    • Requires disclaimers to be included on label indicating that the product does not contain meat or poultry.
    • Expands the authority of the U.S. Department of Agriculture (USDA) over meat and poultry to include PBMAs.
  • The measure addresses cell-cultured products in the following ways:
    • Defines “cell-cultured products” as “any product capable of being used as a human food that “is made wholly or in part from any cell culture or the DNA of an amenable species or live bird” and that “is grown or cultivated outside of the live animal from which the cell culture or DNA was acquired.”
    • Provides USDA with clear authority over labeling and directs the agency to require the words “cell-cultured” or “lab-grown,” in type of uniform size and prominence, to be included immediately adjacent to the name of the food on its label.
    • Codifies the current “shared regulation of lab-grown meat and poultry” between the U.S. Food and Drug Administration (FDA) and USDA, though USDA will retain authority over labeling.
  • The bill has received support from agriculture, poultry, and livestock trade groups, though the Plant-Based Foods Association (PBFA) has voiced its opposition, arguing the Act will unfairly target the growing plant-based food industry. Keller and Heckman will track and report on any developments regarding this Act.