Cell culture foods: considering the legal issues - Food and Drugs Law

The commercialisation of new food products, such as "meat" and "dairy" from new cell-based production techniques, may give rise to a range of intellectual property, regulatory and other legal issues.

Both meat and dairy products are now able to be produced with minimal or no animal involvement.

In the case of cell-based or "cultured" meat, a biopsy may be taken from a live animal, such as a cow, from which stem cells can be derived. Those stem cells may then be engineered and cultured. Once the cells have differentiated into the muscle, fat and connective tissue that make up the meat, they can be harvested, immortalised (i.e. manipulated to be capable of continual reproduction) and then used to produce a potentially infinite range of meat products. To obtain a product that resembles the look, taste and texture of meat, the differentiated cells may be grown on scaffolding materials that support the desired structure of the meat product of interest.¹

These complex technologies have the potential to increase the productivity of food manufacture as they do not involve animal slaughter and, unlike traditional meat products, can be produced in a large scale industrial laboratory.²

While some businesses have been able to cultivate cow mammary cells to produce milk,³ cell-based dairy products are also able to be made without the need for animal cells. Processes using plant microorganisms such as fungi, into which DNA instructions to produce the key milk proteins of whey and casein are inserted, for example, have been developed.⁴

Businesses in this space have now refined the technology to be able to produce at scale, signalling that cell-based meat and dairy has the potential to become a dietary staple.⁵ It is therefore timely to review potentially relevant parts of the legal landscape.

Intellectual property rights in technology

Businesses in the cellular food production space continue to invest heavily in research and development and have sought to protect inventions arising from all aspects of production. For example, patents relating to cell lines (a cell culture developed from a single cell, an essential tool for creating laboratory-grown meat), co-culturing multiple cell types (i.e. muscle cells, fat cells, blood vessels etc.), scaffolding (to allow different cells to adhere and grow alongside each other in a highly controlled and ordered way) and food products (e.g. formed from cultured muscle cells) have been filed in Australia and overseas. Data on patent filings indicates that development in this area is largely being driven by China, with Australia being the fifth largest filing destination for patents relating to imitation meat.⁶

Much like any new field, we expect to see patent challenges in particular relating to the foundational technologies, such as the establishment of cell lines (a cell culture developed for a single cell). We expect lack of novelty and inventive step attacks, drawing on prior art from related fields in which significant patent protection and scientific literature is available, such as biological/biosimilar medicine production.

In circumstances where patent protection cannot be achieved, methods for producing cell-based meat and dairy may be able to be protected as trade secrets. Records and know-how should therefore be treated as confidential and only disclosed on a need to know basis to ensure that the information remains confidential. Copyright may also be available to provide some protection for product formulations or "recipes". Businesses investing in research should ensure they have capacity to demonstrate ownership of technology they have developed or paid to develop.

Food standards

Products produced by way of cellular processes will be considered "food" given that Food Standards laws broadly define food to include any 'substance or thing' capable of being used, or represented to be, for human consumption (excluding therapeutic goods).⁷

In Australia, new and alternative sources of food products (including any new food ingredients or food additives) are treated as novel foods (i.e. non-traditional foods that do not have a history of human consumption in Australia). Such foods require assessment and approval by the regulator, Food Standards Australia and New Zealand (FSANZ), to ensure that they are safe for human consumption.

This is consistent with the limited guidance released to date by FSANZ, which appears not yet to have been approached by any business seeking regulatory approval of a cellular food.⁸

Consumer and food labelling law

Product presentation and advertising claims may raise issues under the Australian Consumer Law and / or the Food Standards Code (enforced by state and territory food authorities under applicable food laws) if they convey messages which are inaccurate or not substantiated in relation to the foods in question.

For example, are cell-based meat and dairy products properly described as "meat" and "milk"? Given the definitions of these products contained in the Food Standards Code⁹ and the requirements of the Australian Consumer Law, additional words or disclaimers might be necessary to minimise risk of non-compliance with such regulatory requirements.

Or will marketers prefer to make a claim of ANIMAL FREE, MEAT FREE or DAIRY FREE? There may not be much "animal", "meat" or "dairy" in the final product but does the derivation of the product from initial animal cell sources make these descriptions and claims misleading?

Branding

As usual, early trade mark protection is desirable, and with an eye to international expansion opportunities. In addition to usual trade mark clearance checks, care also needs to be taken to select a brand which does not convey any unintended health claims or other messages which may be misleading or inappropriate. This is particularly so given that food is the subject of variations and short hand names that can be highly localised.

Product liability

To the extent that production occurs in sterile industrial production conditions, cell-based food products may carry less risk of contamination than those conventional foods produced on farms and involving abattoirs. However, criticism previously levelled at plant-based meat alternatives suggests that products which are more scientifically complex than conventional food sources may be more likely to attract consumer suspicion.¹⁰

Also, as the products are novel products but intended for wide human consumption, it may be difficult to exclude altogether the risk of negative health effects that only become apparent long after product launch. Deployment of state of the art expertise, including through well-designed trial processes and well-documented data, may provide a defence to future product liability claims should there unfortunately be delayed unexpected negative health effects.¹¹

Key takeaways

As well as commercial issues, there are a range of legal and regulatory issues for businesses to manage in relation to cell culture foods. In addition to the opportunity to obtain exclusivity through intellectual property protection, the major regulatory risk issue appears to be obtaining approval of cellular foods as acceptable under food standards laws. A significant issue when products come to market will be the risk of overstating product features, having regard to consumer protection laws.

Footnotes

¹ 'The science of cultivated meat', Good Food Institute (Web Page), accessible here.

² Damian Carrington 'No-kill, lab grown meat to go on sale for first time' The Guardian (Web Page, 2 December 2020), accessible here.

³ Adele Peters, 'This start up is milking cow cells in a lab for animal-free dairy' Fast Company (Web Page, 23 April 2022), accessible here.

⁴ 'Vegan milk that everyone can drink is the real deal' In Habitat (Web Page, 10 March 2022), accessible here.

⁵ In December 2020, US company Eat Just had their cultured meat product "chicken bites", approved by the Singapore Food Agency, the first such cultured meat product approved by a food regulator anywhere in the world. Although Australia is yet to see any cell-based foods approved for consumption, a number of firms are readying for production, such as lab-based dairy manufacturer, Eden Brew, who expect their products to be ready for sale in 2023 - see Simon Evans, 'Eden Brew eyes $20m as lab-made milk rises' Australian Financial Review, 31 May 2022, 18.

⁶ IP Australia, Patent Analytics Hub 'Meat Expectations Innovation trends for substitute meat' July 2020.

⁷ Food Standards Australia New Zealand Act 1991 (Cth), section 5; Food Standards Code, Standard 1.1.2.

⁸ 'Cell based meat' Food Standards Australia New Zealand (Web Page), accessible here.

⁹ Under current Food Standards, meat refers to the whole or part of the carcass of certain animals if slaughtered and excludes a foetus or part of foetuses: Standard 2.2.1; milk refers to the mammary secretion of milking animals: Standard 2.5.1.

¹⁰ Brian P. Sylvester et al. 'From Petri Dish to Main Dish: The Legal Pathway for Cell-Based Meat' (2020) 12(2) Kentucky Journal of Equine, Agriculture, & Natural Resources Law 243, 278.

¹¹ The "state of the art" defence provides a defence where the state of scientific or technical knowledge at the time was not such as to enable a relevant defect to be discovered. See consideration of this defence in Graham Barclay Oysters Pty Ltd v Ryan (2000) 102 FCR 307, where the state of scientific knowledge at the time was not sufficient to enable detection of the presence of hepatitis A in oysters sold, creating a defence to liability for the oyster growers.

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