Search results for: cultured

  • Cell-cultured meat, also known as cultured meat, involves the production of meat from animal cells in a controlled environment. It has the potential to revolutionize the food industry by offering an alternative to traditional livestock farming, with potential benefits such as reduced environmental impact and improved animal welfare. Under the cooperative agreement between FDA and USDA, FDA will have jurisdiction over the preharvest production phase of the animal cell culture technology process, and jurisdiction will transfer to FSIS as the phase enters harvest, i.e., when the process halts the cell’s ability to further grow, multiply, or differentiate into other cell types.  FSIS jurisdiction will continue over the postharvest processing and labeling of cell-cultured meat.
  • As we have previously discussed, the successful FDA issuance of two “No Questions Letters” and USDA’s corresponding two labeling approvals for GOOD Meat and Upside Foods, has prompted FSIS to issue directives to its inspection program personnel (IPP) for future facility inspections.
  • All ingredients, including processing aids, used in products postharvest must be considered safe and suitable by FSIS and used in accordance with their intended use listed in 9 CFR 424.21(c) or FSIS Directive 7120.1. Approved ingredients are allowed to be added to cull-cultured meat food products, provided the intended use of those ingredients is consistent with its application, product type, and any other listed criteria. Any ingredient not listed in the above regulations must be submitted for review as described in FSIS Directive 5020.2.
  • Further, the issued directives inform IPP to refer to FSIS 5000.1 for comprehensive instructions on how to properly verify an establishment’s compliance with sanitation and the Hazard Analysis and Critical Control Point regulations. Additionally, IPP are directed to inspect the establishment’s harvesting and processing operations at least once per shift.
  • Finally, all cell-cultured meat product labels must be submitted to FSIS Labeling and Program Delivery staff for review and approval. FSIS Directive 7221.1 provides additional information for IPP to refer to on verification of the labeling requirements. Keller and Heckman will continue to monitor and report on developments impacting cell-cultivated meats.
  • Following an Advance Notice of Proposed Rulemaking (ANPR) for labeling cell-based meat products issued in September, the issue has been placed on the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service’s (FSIS) list of “long-term actions” – meaning the agency does not intend to have a regulatory action within the next 12 months.
  • This is despite food tech companies’ eagerness to bring cell-cultured meat to the market. A California-based company recently developed what it claims to be a significantly less expensive method to produce edible beef cells and anticipates lowering that cost further at scale.
  • Through the ANPR, FSIS received more than 1,200 comments on an array of questions, including whether labeling should differentiate cell-cultured products from products made from traditionally slaughtered animals.
  • Keller and Heckman will continue to monitor FSIS’s plans regarding regulating cell-based meat products.
  •  Our readers will recall a 2019 agreement by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) on joint oversight of the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish).  Under the agreement FDA will oversee cell collection, growth and differentiation and FSIS will oversee cell harvesting, processing, packaging, and labeling.  As discussed in detail here, on September 3, 2021, FSIS published an advanced notice of public rulemaking (ANPR) seeking comment on the labeling of cell-cultured meat and poultry products.
  • FSIS announced on November 12, 2021 that in response to several stakeholder requests, the comment period for submitting information solicited in the ANPR on the labeling of cell-cultured meat and poultry products, which was initially set to close on November 2, 2021, will be extended by an additional 30 days.  Among the broad range of questions for comment, the main issue is whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  The labels of any cell-cultured meat or poultry products marketed before rulemaking is completed must clearly differentiate the products from slaughtered meat and poultry products, and such labels may need to be changed once final regulations are implemented.
  • The comment period on labeling of cell-cultured meat and poultry products will now end on December 2, 2021.  We will be happy to assist interested parties in submitting comments in response to the ANPR.
  • On September 3, 2021, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) published an advanced notice of public rulemaking (ANPR) to solicit comments and information regarding the labeling of cell-cultured meat and poultry products.
  • By way of background, in 2019, FSIS and the U.S. Food and Drug Administration (FDA) agreed to jointly oversee the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish). Under the agreement, FDA is charged with overseeing cell collection, growth and differentiation, while FSIS is responsible for cell harvesting, processing, packaging, and labeling. FDA is also entirely responsible for the regulation of cell-cultured seafood products other than catfish (as these foods are traditionally regulated by FDA), although the agencies agreed to develop joint principles for labeling to ensure a consistent approach. To that end, the ANPR states that FSIS will consider comments submitted in response to FDA’s Request for Information (RFI) on the labeling of cell-cultured seafood. (See RFI Blog Post).
  • Through the ANPR, FSIS is seeking comment on a broad range of questions related to labeling of cell-cultured meat and poultry products, including the foundational question of whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  A detailed list of questions regarding cell-cultured labeling options for which FSIS is soliciting comments can be found in the ANPR. Additionally, FSIS is requesting economic data and consumer research so that it can better understand the animal cell culture industry. Questions of particular interest to FSIS (e.g., expected number of market entrants) can again be found in the ANPR.
  • FSIS will review the labels of any cell-cultured meat or poultry products that are marketed before rulemaking is completed and ensure that the cell-cultured products are clearly differentiated from slaughtered meat and poultry products, although such labels may need to be changed once final regulations are implemented.  Comments to the ANPR are due by November 2, 2021.  Please let us know if you are interested in submitting comments in response to this ANPR.
  • Comments for the Food and Drug Administration’s (FDA) Request for Information (RFI) for labeling of foods made from cultured seafood cells became due on March 8, 2021. FDA posted the RFI in October 2020 and sought comments primarily on nomenclature concerns (we summarized the RFI here).
  • In addition to a handful of comments from consumers with varied views on cell-cultured meats, FDA received comments from stakeholders such as Memphis Meats, the Environmental Defense Fund, Finless Foods, Center for Science in the Public Interest (CSPI), and The Vegetarian Resource Group. Other comments not yet posted have been released from individual entities, including BlueNalu, Inc., Good Food Institute (GFI), and a joint comment from the Alliance for Meat Poultry and Seafood Innovation and the National Fisheries Institute. Some highlights from the comments are provided below.
    • Most comments encouraged FDA to encourage product identity statements that differentiate seafoods cultured from cells from traditional farmed or wild-caught products. Many industry comments indicated support for the term “cell-cultured” seafood or “cell-based” seafood, which many said signal to consumers that the product is not plant based and is distinct from “wild caught” or “farm raised” seafoods. Many of these comments cited two studies from Rutgers University on consumer perceptions of potential labeling terms of cell-cultured meats: Hallman & Hallman (2020) and Hallman & Hallman (2021) (both underwritten by BlueNalu, which provided a detailed summary of the studies in its comment).
    • Some comments noted that if a term such as “cell-cultured” were to be added to product identity statements, it should also appear in ingredient descriptions following the common or usual name of the ingredient (e.g., INGREDIENTS: Minced Pollock (cell-cultured seafood).
    • Other comments, including those from GFI and the Vegetarian Resource Group, suggested that descriptive phrases such as “grown from cells” or “engineered using cultured [fish species] cells” would be more effective at preventing consumer confusion given no term has yet leveraged common understanding in the new industry.
    • Some comments also suggested that FDA need not update The Seafood List, a nomenclature and labeling reference for seafood, as the term “cell-cultured” could be used in conjunction with the names on the list to form statements of identity.
  • As our readers know, FDA and the U.S. Department of Agriculture have a formal agreement that confirms that FDA has sole regulatory oversight over food derived from cultured seafood cells, other than cells from siluformes fish (i.e. catfish) that fall under USDA jurisdiction. While FDA is expected to release guidance informed by these comments, it has not released a established a timeline for doing so.
  • On October 19, 2019, organizations representing conventional and cell-based /cultured meat, poultry, and seafood companies, including the Alliance for Meat, Poultry and Seafood Innovation and the North American Meat Institute, wrote a letter to the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) stating that “although these products have not yet come to market in the United States, market entry is fast approaching, and there is significant interest in the regulation of these products, particularly regarding applicable labeling requirements.”
  • In their letter to USDA, the groups stated that they are committed to supporting and complying with principles that ensure labeling is truthful and not misleading, does not disparage cell-based/cultured or conventional products, enables consumers to distinguish between such products, and is consistent with the safety and nutritional qualities of the product.
  • By way of background, in 2019, USDA and the U.S. Food and Drug Administration (FDA) announced a formal agreement that stated that both agencies would jointly oversee the production of human food products derived from the cells of livestock and poultry.  The agreement stated that FSIS will have oversight of the labeling of cell-based/cultured meat and poultry while the FDA will oversee the labeling of cell-based/cultured seafood.  Moreover, on October 6, 2020, FDA issued a Request for Information on the labeling of foods comprised of or containing cell-based/cultured seafood, in which FDA notes that it intends to use the information and data resulting to determine what type(s) of action, if any, the Agency should take to ensure that these foods are labeled properly.
  • In the letter, the groups urged USDA to also solicit data to propose and establish an appropriate mandatory labeling requirement for cell-based meat and poultry products.  The groups recommended that FSIS issue an Advance Notice of Proposed Rulemaking (ANPR) to obtain more information and supporting data on finished product characteristics for cell-based/cultured meat and poultry products, mainly those that may require labeling, as this information will provide FSIS with substantive data needed to better inform the Agency’s decision-making process.  The groups added that FSIS has issued ANPRs to obtain information from industry, consumers, and other stakeholders in the past, and that it could do so for the labeling of cell-based/cultured products as well.

 

  • As covered on this blog, on March 7, 2019 the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” whereby FDA will have regulatory oversight at the stages of collection, growth and differentiation of cells and USDA oversight will begin at cell harvest for food products derived from the cultured cells of livestock and poultry.  For food derived from cultured seafood cells, other than cells from Siluformes fish under USDA jurisdiction, FDA oversight will continue over the processing, packaging, and labeling stages.  In this regard, the 2019 agreement provides that FDA and USDA will develop joint principles for product labeling and claims to ensure that products under each agency’s jurisdiction are labeled consistently and transparently.
  • In an October 7, 2020 Federal Register notice, FDA solicited comments, studies, and relevant data or information on consumer understanding of terms pertaining to the labeling of foods comprised of or containing cultured seafood cells.  The 5 topics for which input is solicited are:

1. Whether the name or statement of identity of foods comprised of or containing cultured seafood cells should inform consumers about how the animal cells were produced;

2. What terms should be in the name or statement of identity of a food comprised of or containing cultured seafood cells to convey the nature or source of the food to consumers, e.g., “cell cultured” or “cell based” or “cell cultivated;”

3. Whether there is agreement with FDA’s view that foods comprised of or containing cultured seafood cells are not yet in the marketplace and, therefore, do not have common or usual names established by common usage;

4. Whether terms that specify a certain type of seafood (such as “fillet” or “steak”) should be included in or accompany the name or statement of identity of foods comprised of or containing cultured animal cells; and

5. What attributes (such as nutrition, taste, texture, or aroma) vary between conventionally produced seafood as compared to foods comprised of or containing cultured seafood cells, and should be considered material to consumers’ purchasing and consumption decisions.

  • FDA has provided additional questions in subparts for certain of the above topics and has requested an explanation of the reasoning for each comment that is submitted, along with studies, data, and other supporting evidence as applicable to the topic that is being addressed.  The solicitation period for comments is scheduled to close on March 8, 2021.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • The U.S. Government Accountability Office (GAO) recently released a report (the “Report”) which issues recommendations regarding FDA and USDA cooperation on regulatory oversight of cell-cultured meat and details the challenges of commercialization where much of the technology for commercial production is either still in development or being safeguarded as a proprietary technology.
  • In March 2019, the FDA and USDA announced that the FDA would oversee the early phases of cell-cultured meat production (including obtaining cell samples, cell selection and storage, and cell growth) through the point of harvest, at which point oversight would transfer to USDA to regulate food processing, including labeling.
  • The Report issues a number of recommendations for increased interagency cooperation to prepare for regulation of cell-cultured meat and also identifies a plethora of open questions which pose challenges for commercialization:
    • Tissue Collection – What animals will be used collect biopsy samples and how often will biopsies be required?
    • Genetic Engineering – Will selection of desirable traits in cells use genetic engineering?
    • Antibiotics – Will antibiotics be used, and if so, in what amounts and at what stages of production?
    • Growth Medium – What type will be used?
    • Scaffold – Will cells need to be attached to scaffolding structure during the growth stage, and if so, will the scaffold be edible?
    • Point of Harvest – How will this be defined by FDA and USDA and how will jurisdiction be transferred?
    • Scaling up Production – Do firms have the necessary equipment for production at a commercial scale?
    • Production Cost – Can firms make an affordable product, in particular where the growth medium represents a significant cost?
    • Safety Consideration – Are there new safety hazards and to what degree will this depend on the method of production?
    • Production Composition – What will the composition of the eventual products be, including any binding, flavoring ingredients, and plant-based materials?
    • Environmental, animal welfare, and health impact – There exists disagreement as to the advantages of cell-cultured meat over traditional meat products.
    • Timeline to Market – When will cell-cultured meat be available to consumers?
    • Labeling –  How will cell-cultured meat be labeled, and will federal requirements preempt any requirements in place at the state level?  
    • Consumer Acceptance – Will consumers purchase cell-cultured meat products?
  • While cell-cultured meat holds much promise, given the many uncertainties the industry still faces, from both a technology and regulatory perspective, it may be some time before consumers find cell-grown meat in the store.  We will continue to monitor and report on developments that impact the development of he cell-cultured meat industry.
  • As previously reported on this blog, there has been considerable discussion around the regulation of cell-cultured meat both at the federal and state levels. Earlier this month, USDA and FDA published a formal agreement regarding federal agency oversight of human food produced using cell technology. Under the formal agreement, FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, where regulatory oversight will then transfer to USDA, which will conduct inspections of establishments where cultured cells are harvested, processed, packaged, and labeled, in accordance with FSIS regulations.
  • However, there have been parallel discussions at the state level, with a focus on the labeling of cell cultured products. For example, an Arizona state lawmaker recently introduced a bill that, if enacted, would make it illegal to label a product as “meat” if it is “not derived from harvested production livestock.” The same restrictions would apply to labeling a product as “chicken,” if it was not once live poultry. The bill, HB2604, was introduced to the Arizona House Committee on Land and Agriculture by David Cook (R-Globe), with specific intention to prevent cell-cultured meat from being labeled “meat.” However, HB2604 was not met without criticism. For instance, some lawmakers questioned whether the bill could withstand a federal preemption legal challenge. And while the bill failed to pass the House, it is up for reconsideration within the month.
  • As our readers are aware, Arizona is not the only state stepping into the discussion. Missouri, Nebraska, South Dakota, North Dakota, and several other states have introduced legislation that would prohibit representing a product as meat that is not derived from livestock or poultry. And as interest in cell-cultured meat continues to grow, more states are likely to enter the debate. We will continue to monitor and report on regulatory activity in this area.
  • As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) in a November 16, 2018 joint press release, announced an agreement on joint regulation of cell-cultured meat.  Though the framework was not released at the time, the press release indicated that under the agreement, FDA will oversee “cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry”.  As we noted at the time, the scope of USDA inspection was not addressed and the Agencies agreed that no legislation would be necessary to effectuate the joint agreement.
  • On March 7, 2019, USDA and FDA published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides some indication of expected inspectional burdens on industry – the agreement includes a provision that USDA will “require each establishment that harvests cells cultured from livestock or poultry . . . for the purpose of producing human food required to bear the USDA mark of inspection, processes those cells into such human food products, or packages and labels such products, to obtain a grant of inspection, as required by the FSIS regulations.” In addition, USDA will conduct “inspection in establishments where cells cultured from livestock and poultry subject to the FMIA and PPIA are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations (including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review), to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.” As FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, FDA also will conduct inspections at those facilities to ensure compliance with FDA laws and regulations.
  • In contrast, the formal agreement provides no clarity on the statutory basis for USDA regulation.  As opposed to the press release in November, which indicated that no legislation would be necessary, the formal agreement indicates that FDA and USDA “will undertake a joint process to identify any changes needed to statutory or regulatory authorities to effectuate” the agreement.
  • Keller and Heckman will continue to track the regulation of cell-cultured meat.