Guest article: The Perfect Day lawsuit… an ingredient naming case in disguise?

Perfect Day uses microbes—instead of cows—to make the dairy protein beta lactoglobulin

Companies such as Perfect Day that use emerging tech to make alternatives to animal-derived ingredients are particularly vulnerable to labeling lawsuits, "both because their ingredients are made using novel and not easily understood processes, and because they pose a competitive threat to conventional industry interests," argues Rebecca Cross
Image credit: istock-damnura

Rebecca Cross is the founder of Greenfare Law, a boutique law firm advising companies at all stages of growth on wide range of legal issues, including advertising, labeling, product safety, supply chain management, and IP protection.

The views expressed in this article are the author’s own and do not necessarily represent those of AgFunderNews.


What’s in a name? And would a rose by any other name really smell as sweet?

As more food tech companies move to commercialization, one of the thorniest challenges is how to name and label novel ingredients — balancing regulatory compliance, brand strategy and consumer trust.

While product naming, or standards of identity, has drawn plenty of attention, the naming of ingredients themselves has received far less public scrutiny. A recent lawsuit against Perfect Day brings this issue to the forefront, raising important questions about how companies describe what their ingredients are — and are not.

The lawsuit, filed by the Organic Consumers Association and Toxin Free USA against Perfect Day, alleges that the company’s core ingredient — branded as ProFerm and described as “animal-free whey protein” — is misleadingly named.

‘This lawsuit reads more like a challenge to the category itself’

The plaintiffs argue that the ingredient is not equivalent to cow-derived whey protein because it contains high levels of residue from the fermentation process. Their claims rely on an exceptionally sensitive testing method, not typically used to detect fermentation residues in food ingredients, potentially exaggerating the level. In their view, calling the ingredient “whey protein” implies a level of purity or equivalency that is misleading.

From a regulatory perspective, Perfect Day had received a no questions letter from the FDA affirming the GRAS (Generally Recognized as Safe) status of its ProFerm. In the letter, the FDA declined to take a position on how the ingredient should be named.

The FDA’s only professed concern regarding labeling was that it convey the inclusion of allergenic milk proteins — signaling that whatever ingredient descriptor Perfect Day used, it needed to make clear the ingredient is a milk protein. To navigate this, Perfect Day chose to describe its ingredient as a whey protein made by microflora rather than cows, while also emphasizing its functional identity to milk.

Given Perfect Day’s transparency’s and the Organic Consumers Association’s persistent opposition to food technology, this lawsuit reads more like a challenge to the category itself than a response to consumer deception.

Regardless, it illustrates the tightrope companies walk when naming alternative ingredients.

How do you name an ingredient that is common and usual in one respect but novel in another?

Many food tech companies plan to give their ingredients proprietary brand names, similar to Perfect Day’s ProFerm. But FDA labeling regulations still require a common or usual name describing the ingredient.

And this creates inherent tension for companies using precision fermentation, gas fermentation, molecular farming, or other novel platforms to produce familiar compounds—like proteins, fats, or flavors.

How do you name an ingredient that is common and usual in one respect but novel in another? What if the most scientifically accurate description is also the least intelligible for consumers?

The FDA has never issued guidance specifically clarifying how common or usual names should be determined for ingredients. While the FDA has stated that significant changes in an ingredient’s manufacturing process can affect regulatory status, it does not detail how those changes might affect the ingredient’s name.

In practice, many ingredients produced through alternative processes use the same common or usual name as their conventionally produced counterparts. Notably, since its FDA approval in 1990, rennet produced via precision fermentation has been described using the same name as traditional rennet derived from animal sources.

Companies using emerging technologies to make alternatives to animal-derived ingredients are particularly exposed

There is no pre-market review process at FDA for determining ingredient names. Companies may consult with the agency and often include proposed labeling language in their GRAS submissions, but the FDA’s Office of Food Additive Safety (OFAS) generally declines to opine on naming.

In response to GRAS notices, OFAS typically states: “Issues associated with the naming of a food ingredient are the purview of the Office of Nutrition and Food Labeling; we did not consult with that office.”

OFAS may also refer companies to 21 CFR 102.5(a) — a regulation narrowly intended to govern how common or usual names for non-standardized foods may be established by regulation, but sometimes referenced for its general principles outside that context.

This is a flexible regulation that emphasizes simplicity, providing that a name should be “in as simple and direct terms as possible” and should describe “the basic nature of the food or its characterizing properties or ingredients.”

This regulatory flexibility has some advantages. It allows companies to proactively choose an ingredient name that aligns with their product positioning and consumer understanding. But one disadvantage is that it leaves companies vulnerable to challenges that the chosen terminology is misleading.

Companies such as Perfect Day that use emerging technologies to make alternatives to animal-derived ingredients are particularly exposed — both because their ingredients are made using novel and not easily understood processes, and because they pose a competitive threat to conventional industry interests.

Mitigation strategies

Contextualize marketing representations: Consider pairing terms like “animal free” with concise consumer-friendly explanations of the production process — on pack, not just online. Similarly, use broad claims like “identical to X” with caution; even small immaterial compositional differences can expose companies to legal risk.

Maintain rigorous testing documentation: Anticipate how plaintiffs might attempt to challenge your ingredient’s labeling, and conduct regular testing to insulate against such risks. In my prior life as a litigator, I defended a food company whose nutrition facts were challenged in a series of class actions based on testing allegedly showing the values were off by 60-70%. By presenting rigorous testing using more appropriate methodology (and a cost-shifting procedure), we were able to resolve each case for $1,000.

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REPORTING ON THE EVOLUTION OF FOOD & AGRICULTURE
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