Decoding Novel Food Labeling Challenges

Novel foods and ingredients are entering the food supply faster than at any time in living memory. Among the many problems that accompany this influx is the question of how to label these products. This includes asking what they should be called in the ingredient list, what is appropriate on the primary display panel, and what additional information consumers may want or need.

The idea of using the common and usual name for foods and ingredients that are inherently uncommon or unusual is problematic. Furthermore, being truthful and not misleading is challenging when even the innovators can’t agree on what to call some of these products (e.g., cultured, cultivated, or cell-based meat).

Federal Activity

At the national level, the labeling of all food products is regulated by either the U.S. Food and Drug Administration (FDA) or the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS). Although their statutory authorities differ significantly, these agencies adhere to similar labeling principles. Unlike the systems employed in many other countries, all new foods and ingredients are subject to the same oversight, regardless of their degree of novelty. Three of special interest are cell-cultured foods, plant-based alternatives, and precision fermentation products.

Cell-Cultured Foods. The prime example of the difficulty in labeling novel foods and ingredients lies in products made from cell cultures. Under a formal agreement between the FDA and the USDA, the FDA established a premarket consultation process to evaluate production materials and processes and oversee cell culturing. At the time of final harvest, regulatory oversight for products derived from livestock, poultry, and Siluriformes fish (catfish), including labeling, transfers to the FSIS. The FDA regulates the production and labeling of all other cell-cultured foods.

The FDA took the first step in developing a policy on the labeling of cell-cultured seafood products by issuing a public Request for Information (ROI) in 2020 (FDA 2020). This ROI includes an extensive description of the agency’s statutory authorities and misbranding regulations. Under these, labeling must not be “misleading, either affirmatively or by omission of material” and “words or statements required to appear on the label or labeling be in such terms as to render them likely to be understood by the ordinary individual under customary conditions of purchase and use.” Foods that don’t have common or usual names must be “labeled with an accurate description of the food or a fanciful name commonly used by the public.”

The FSIS took a similar first step by publishing an Advanced Notice of Proposed Rulemaking (ANPR) in 2021 (USDA FSIS 2021). As described in this ANPR, the requirements for labels to be truthful and not misleading are the same for FSIS-regulated products as they are for FDA-regulated foods. The most significant difference between the FSIS and the FDA authorities is that the FSIS has premarket label review and approval authority that applies to cell-cultured products.

The FDA completed the first seafood cell culture premarket consultation in May 2025 (FDA 2025). The agency’s response letter for that consultation explicitly states that the Innovative Food Staff responsible for the consultation did not consider product labeling or consult with the Human Foods Program Office of Nutrition and Labeling (ONFL). This response directs the submitter to consult with the ONFL, but since this response is very recent, it is too early to know what or when labeling insights will emerge from the ONFL. Interestingly, the FDA refers to the product as “cultured salmon cell material” in the response letter while disavowing the use of that terminology as the common or usual name.

Three products have completed both the FDA and the USDA premarket review. Two of these products marketed at retail (Mission Barns fat and Good Meat chicken) have ingredient information available on the companies’ websites. According to that information, the Mission Barns product is labeled as containing cultivated pork, and the Good Meat product as containing cultivated chicken. Label information is not available for a cultivated chicken product from Believer Meat that has completed the FDA review but has not received the USDA label approval.

It remains unclear whether and how the two agencies will harmonize their labeling policies for cell-cultured foods. Given the current restrictions on the ability of either agency to issue guidance and regulations, it is unlikely that there will be concrete action at the federal level soon.

Plant-Based Alternatives. Another area of rapid development is plant-based foods. While these products have been on grocery shelves for decades, they have transitioned from being niche products to the mainstream. In many cases, the proper designation of a plant-based ingredient (such as pea or mushroom protein in snack bars) is clear, but in other cases, the appropriate name remains contentious.

In 2023, the FDA addressed one aspect of this problem by publishing draft guidance on labeling for plant-based alternative milks (FDA 2023). The need for this guidance was triggered by the proliferation of plant-based milk products, including those made from various species of legumes, nuts, grains, and seeds. The draft guidance states that the use of compound terms such as “almond milk” for these products is acceptable because consumer research has shown that these labels do not cause confusion. Perhaps this is not surprising given that plant-based milks have been used for centuries.

Publication of the draft guidance was accompanied by the opening of a docket on Regulations.gov to receive comments from the public. To date, the agency has received over 900 comments from both consumers and industry, and the docket remains open. There are sharp divisions within both the consumer and industry groups between those who support the agency’s approach and those who assert that it is misleading.

In January 2025, the FDA published a second draft guidance on labeling other plant-based products (FDA 2025). As with the plant-based milks, the basic principle is that these products should be designated using the name of the specific plant species used in the product. Examples in the draft guidance include “black bean mushroom veggie patties,” “chia and flax seed egg-less scramble,” and “cashew cheese spread.” The docket for submitting comments on this draft guidance is also available at Regulations.gov. To date, more than 120 comments have been received, and the docket remains open.

Precision Fermentation Products. Microbial and fungal fermentation have been used for centuries to produce medicines, food, ingredients, and processing aids. The term precision fermentation has no generally agreed-upon definition. For example, a 2025 review by the Food and Agriculture Organization of the United Nations (FAO) lists more than 40 definitions found in the scientific literature and online industry sources. Many of these definitions link the term to the use of advanced bioengineering and genetic technologies for the industrial-scale production of molecules identical to those found in plants or animals.

Examples of precision fermentation products include individual milk and egg proteins, leghemoglobin, lactoferrin, and human milk oligosaccharides.

These products have primarily been regulated as Generally Recognized as Safe (GRAS) substances. As with all GRAS substances, the FDA expects these products to be labeled with their common and usual names. However, the agency’s GRAS notification response letters do not address product names, again referring submitters to ONFL, which has not published any guidance on labeling these products and does not disclose whether the submitters have reached out to them. In contrast, the agency has been clear that any fermentation products that mimic a protein from one of the nine major food allergens must be labeled according to the requirements of the Food Allergen Labeling and Consumer Protection Act.

An additional labeling consideration for these products is the credence claims often applied to ingredients produced through precision fermentation and the foods that contain them. These include statements such as animal free, sustainable, carbon neutral, and environmentally friendly. Because these claims are unregulated and undefined, their use could create business risk from potential consumer claims that the product is mislabeled or from criticism on social media.

State Activity

The absence of formal regulation at the federal level, along with divisions within consumer communities and industry segments, has created an opportunity for state governments to assert their local authority over food labeling. In most cases, the justification for these laws is claimed to be a perceived need to prevent consumer confusion.

The number of enacted and proposed state laws grows almost monthly. Some of these laws mandate specific wording to describe novel products, while others prohibit the sale of these products within the state. Two examples of the first type of law are those enacted in Missouri in 2018 and Oklahoma in 2020, which were the first to go into effect. Missouri prohibits “misrepresenting a product as meat that is not derived from harvested production livestock or poultry.” Oklahoma has a similar provision but permits labeling that “displays that the product is derived from plant-based sources.” An example of the second type of statute was enacted in Florida in 2025. This statute prohibits the manufacturing, sale, holding, or distribution of cultivated meat.

Many of these laws have been challenged in court with mixed results. It is likely that clarity regarding what each state can and cannot do will not be reached until after lengthy appeals processes.

Going Forward

The development and marketing of novel foods and ingredients is a complex process. Success depends on overcoming technical problems, production limitations, and regulatory hurdles. However, ultimately, commercial success depends on consumer acceptance. Product names and labels play a crucial role in supporting consumer acceptance. Still, developers and manufacturers must ensure that this information meets changing regulatory standards while also communicating novelty without creating confusion. Stay tuned; there’s much more to come.ft