Washington, D.C. — Biotech startup Perfect Day is currently facing allegations of misleading the public about its animal-free dairy products. A lawsuit filed by the Organic Consumers Association and Toxin Free USA in the District of Columbia claims the company falsely advertised the safety, environmental friendliness, and GMO-free status of its laboratory-created whey protein, known as ProFerm.
ProFerm utilizes beta-lactoglobulin produced through precision fermentation, employing a genetically engineered version of the fungus Trichoderma reesei. Despite being granted GRAS (Generally Recognized as Safe) status by the FDA following a 2020 no-questions letter, recent findings suggest significant discrepancies between the company’s claims and the product’s actual composition.
According to the lawsuit, laboratory analyses conducted by The Health Research Institute (HRI) have highlighted that a substantial 86.6% of ProFerm consists of residual fungal proteins from its production process. This is a stark contrast to the figure of up to 6.7% reported by Perfect Day based on tests by the Food Allergy and Resource Program at the University of Nebraska-Lincoln. This discrepancy raises serious concerns about the product’s declared composition and its safety profile.
The lawsuit also alleges the presence of unknown fungal byproducts and metabolites in ProFerm that may produce unanticipated effects when consumed. The plaintiffs argue many of these fungal components have never been tested as part of the human diet and their impacts on health, allergenicity, nutrition, and gut microbiome are not sufficiently understood.
Additionally, there is apprehension regarding ProFerm’s designation as non-GMO. Perfect Day’s stance, consistent with U.S. food labeling laws, is that while genetic engineering is employed in production, no genetically modified material remains detectable in the final protein product. This classification has been challenged in the lawsuit given the origins of the protein in a GMO fungus.
Perfect Day’s use of Trichoderma reesei is defended on grounds of its historical safety in large-scale food enzyme production, as noted in their GRAS notification to the FDA. The company cited comprehensive literature reviews and bioinformatic analysis of the fungus’s proteins to substantiate their safety claims.
Despite these issues, Perfect Day continues to make strides in the dairy alternative sector. The startup has previously launched various consumer brands through its subsidiary, The Urgent Company. However, focusing on forming partnerships with larger consumer goods companies and scaling production, Perfect Day sold these brands in 2023 to a new entity, Superlatus.
Interestingly, this legal action marks a notable development in the evolving dialogue surrounding biotechnological innovations in the food industry. It stresses the broader conversations about transparency, safety, and consumer rights in emerging food technologies.
Moreover, the attention garnered by this lawsuit underlines the complexity and potential conflicts in introducing precision-fermented products that challenge traditional agricultural practices. As the sector rapidly expands, the need for clear regulations, transparent practices, and robust safety assessments becomes increasingly apparent, ensuring both innovation and consumer protection advance hand-in-hand.
As the case progresses, the implications of this legal challenge extend beyond just Perfect Day, potentially influencing future practices and disclosures across the industry focused on synthetic biology and alternative proteins.
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