Carmine (a red dye sourced from the cochineal beetle) has been responsible for the crimson, cherry, ruby, and rose shades in color cosmetics for decades. In fact, the ingredient has been around since 2000 BCE. But its chromatic legacy has faults: 70,000 cochineal beetles are required to produce a fifth of a pound of the ingredient, plus it has been known to cause allergic reactions ranging from urticaria to anaphylaxis. Also referred to as natural red 4, cochineal extract, or E120, in a time of vegan cosmetics and rising allergy rates, carmine is in need of  a modern makeover.

In 2009, following the submission of a 1998 citizen petition to the FDA by the Center for Science in the Public Interest and reports of severe allergic reactions to cosmetics and foods containing the additive, labels were required on all food and cosmetics products containing it. These labeling requirements went into effect in January 2011, but that still didn't change the imperative need for a substitute. However, color additives require FDA approval before going to market (unlike cosmetic products and ingredients), complicating the road to a new ravishing rouge.

While other pigments like beetroot extract and iron oxides have been used in vegan formulas, there are issues like limited heat stability, petrochemical-derivatives, and variation in undertones to contend with. For those craving the vibrant, blue-based red of carmine, there was nothing that quite hit the same mark.

Now the L’Oréal-backed biotech innovator Debut has unveiled a vegan, bioidentical alternative four years in the making. Its team of 10 researchers unlocked this innovation by discovering two new enzymes in the beetle responsible for its shade production. "We have invested a significant amount in achieving the scientific breakthrough in the bioproduction of carmine as we were determined to conquer this molecule. As the only biotech company to have achieved the first-ever molecular replica of carmine, our investment to date and future investment will transform beauty and eliminate animal-derived carmine at long last," founder Joshua Britton tells Beautymatter.

Debut’s renewable ingredient is anchored in the company’s proprietary Bio2Consumer platform and ranked at 95% purity versus the industry’s average of 30%. Due to the absence of carminic acid in the ingredient, it also doesn’t carry the same allergen and irritant risk as the traditional variant. It boasts anti-inflammatory and antioxidant properties as well. But the road to commercializing this innovation also comes with its own set of legislative challenges.

While Debut's bio-carmine falls under the established INCI for traditional carmine, because the original approved colorant must be derived from the beetle according to FDA articles, Debut will soon be educating the organization on its biomanufacturing processes to speed up its market entry. At present, the company is looking to launch the product to the beauty industry in 2027 through BiotechXBeautyLabs, its contract manufacturing arm. 

“When the petition was originally approved by the FDA, biotechnology was still in its infancy, and thus the documents were not yet set up to allow for biotech sources that are identical in chemical structure but of significantly higher purity. Breakthrough innovation such as our biomanufactured carmine will clearly necessitate an update of FDA statutes. This comes with the territory. It will be incumbent upon Debut, and some of our partners, to educate and elucidate the FDA on why our bio-carmine is superior to animal-derived carmine,” he explains. “Our bio-carmine is the same exact molecule as natural carmine, minus the questionable environmental and ethical practices that have only survived this long because there has been no scientific breakthrough—until now. That is something that the FDA will certainly be happy to back.”

Despite the additional hurdle, Britton remains optimistic about the road ahead. "At Debut, we regard education—whether we are educating the FDA, brands, or consumers—as a key priority. Our mission at the company is to see to it that our biotech innovation makes its way out of the lab and into the hands of consumers as speedily as possible. It’s what drives us to continue innovating: to elevate consumers’ lives with novel ingredients and formulations, and we are eager to champion our technology,” he adds.

Given Debut’s pharmaceutical level of rigor and testing and drive to innovate, potentially reforming FDA policies is a natural evolution of their mission. “We embrace regulation, even welcome it. Debut will soon be creating novel ingredients for acne, eczema, and dandruff in the near horizon, and those ingredients will fall under FDA drug territory. That is a well-defined process that we look forward to tackling,” Britton notes.

That process could even include a potential collaboration in the future. “Government agencies such as the FDA could always use more resources, especially when it comes to shepherding innovation. I’d personally love to work with the FDA at an early stage in the development timeline, take them on the innovation journey right from the beginning,” he says.

According to a report by Renub Research, the global carmine market was worth $48.62 million in 2024 and will reach $85.4 million by 2033. Meanwhile Precedence Research states that the global vegan cosmetics market size is worth $19.35 billion in 2025 and will reach $3.39 billion by 2034. In January 2025, the FDA banned FD&C Red No. 3 in food and ingested drugs, citing two studies that showed cancer in laboratory rats exposed to high levels of the dye. Food manufacturers will have until January 15, 2027 (ingested drugs until January 15, 2028) to change their formulas. Those three factors combine for a hugely lucrative market opportunity. Debut’s bio-carmine is currently priced higher than natural carmine, but the company anticipates a cost reduction as it scales and optimizes its biomanufacturing process. 

“I firmly believe that Debut can take the entire carmine market,"  Britton states. "The industry has waited long enough for innovation such as this.”