Pivotal food regulatory updates in the United States are poised to clarify or revamp approaches to novel food tech innovations including plant-based and cultured (cultivated) meats, and transgenic crops.
2024 is abuzz with food regulatory developments, many of which impact food tech innovations like plant-based meat, transgenic crops and cultured meat. It is a particularly big year for food regulation as the FDA and USDA work to implement their regulatory agendas ahead of a possible change in administration after the 2024 U.S. Presidential election.
As we approach mid-year, notable regulatory developments include:
- FDA’s publication of long-awaited Guidance for Industry titled Foods Derived From Plants Produced Using Genome Editing. This Guidance clarifies FDA’s thinking with regard to safety assessments for foods intended for human or animal consumption derived from genome-edited plants, and describes the premarket processes developers may use to voluntarily engage with FDA.
- USDA’s Final Rule on Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims. Under this rule, FSIS-regulated meat, poultry and egg products bearing voluntary U.S.-origin claims must now come from animals born, raised, slaughtered, and processed in the United States.
- USDA’s Request for Information (RFI) soliciting stakeholder input on the electronic or digital link disclosure option for bioengineered (BE) foods under the National Bioengineered Food Disclosure Standard. This stems from a recent court ruling directing USDA’s Agricultural Marketing Service to consider potential revisions to the electronic or digital link BE disclosure options.
- A Joint Regulatory Plan for Biotechnology announced by EPA, FDA, and USDA on May 8, 2024 to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. These actions will focus on modified plants, modified animals, modified microorganisms, human drugs, biologics, and medical devices, and cross-cutting issues.
Looking ahead, we anticipate FDA will publish further guidances on a range of issues, including notable topics like:
- Plant-based food labeling.
- Cell Culture Consultations, a premarket review process for cultured meat.
- Heavy metals in food intended for babies and young children.
- FDA’s Food Traceability Rule.
- Preventive Controls for Chemical Hazards.
Several factors may affect the FDA’s ability to issue the planned guidances, including new administration priorities and emerging public health issues.
These forthcoming guidances are all relevant to food tech developers as these documents will set forth FDA’s interpretation of existing FDA rules regarding safety, manufacturing and labeling. For example, at this time, numerous cultured (cultivated) meat developers are engaging with FDA as part of that agency’s premarket Cell Culture Consultation process. It’s an iterative process, with numerous meetings and touchpoints between FDA and developers. This process will likely be well-served and further streamlined with clearly defined, published guidance from FDA that outlines the agency’s expectations on the type of data and information needed to successfully demonstrate safety.
Turning to plant-based foods, as these products proliferate in the U.S. marketplace, questions abound regarding lawful product naming and claims. This has captured the interest of FDA, stakeholders and Congress culminating most recently in FDA's publication of its Draft Guidance on Plant-Based Milk Alternatives last year, a particularly popular category of plant-based foods.
This year, we also anticipate that FDA will publish Draft Guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods and that USDA-FSIS will publish a proposed rule on the labeling of meat or poultry products comprised of or containing cultured animal cells. The naming and labeling of these products will have a substantial impact on consumer acceptance. When the FDA draft guidance and USDA-FSIS proposed rule finally publish, there will be opportunities for food tech developers and other stakeholders to weigh in via comments to the regulators. This will be a critical time for food tech developers, in particular, to align on what naming conventions will work best from both a legal and marketing perspective to ensure the success of these novel products for years to come.
Brian Sylvester’s Food and Beverage Regulatory team at Perkins Coie interfaces extensively with FDA and the USDA on behalf of a range of start-up and multinational clients and is available to provide additional insights on these and related issues. Reach out to Brian via LinkedIn or at [email protected].
Brian Sylvester and Perkins Coie LLP are official prize partners of XPRIZE Feed the Next Billion. This is a multi-year, $15M competition that incentivizes teams to produce chicken breast or fish fillet alternatives that replicate or outperform conventional chicken and fish in: access, environmental sustainability, animal welfare, nutrition, as well as taste and texture. Follow along to find out more about this competition at xprize.org/feed.