Color has always been up for interpretation.
Red, for example can imply love or, alternatively, rage. The color is routinely used as a warning of danger, but in some cultures, it’s thought to ward off evil spirits. In nature, red is both a signal that something is poisonous or an indicator that it’s ripe and ready to eat.
While colors are up for interpretation, science generally is not.
Health misinformation has always existed, but took centerstage during the pandemic when isolation drove people to social media — which quickly became a powerful tool for disseminating false narratives and blurry science.
More recently, health influencer narratives have gained the backing of government authorities, which puts fact-based industries in a precarious spot. Whether it’s fluoride in drinking water, acetaminophen use by pregnant women, or the inclusion of synthetic dyes in supplements and drugs, the evidence of safety risks doesn’t add up.
This issue’s cover story focuses on the FDA revocation of Red No. 3 for use in food, dietary supplements and ingested drugs. While more commonly used in the food industry to give a cherry-red color to things like candy, fruit juices and cereals, the synthetic dye, known globally as erythrosine, is also used in the nutra and pharma spaces for coated tablets, syrups and gelatin capsules.
While the MAHA consumer narrative is heralding the FDA’s January 2025 revocation as a victory, scientists are not on board. The decision — based on an almost 70-year-old clause in the Food, Drug and Cosmetic Act that predates modern toxicology and risk assessment tools — represents a potentially precarious tipping point for pharmaceuticals, where misinformed consumer narratives could supersede actual scientific data.
In fairness, synthetic dyes are commonly associated with highly processed foods, and nutritionally, these types of foods leave a lot to be desired. However, there is no credible evidence of a causal link between so-called petroleum-based dyes and health risks — such as cancer or hyperactivity in children. And yet, flawed studies and political rhetoric have consumers believing otherwise.
For the pharma industry, having to reformulate products to eliminate synthetic dyes comes with several obstacles, most of which are time-consuming and expensive. There will always be a small subpopulation of people who have certain reactions to additives and dyes, and clear labeling should facilitate awareness of ingredients, allowing consumers and patients to make their own personal choices. But to collectively force entire industries to shift to natural colorants without credible safety concerns would be a waste of time, effort and money. In the pharma industry, those things are much better spent on R&D and future medical innovations.
After the departure of hundreds of FDA employees, former acting commissioner and CDER director Janet Woodcock recently advised the pharma industry to step up, fill the void and help shape policy from outside the agency. While it isn’t yet clear if the push for natural ingredients in pharma will extend beyond Red No. 3, now is the time for the industry to ban together to advocate strongly for good science to drive decision-making.
Science shouldn’t shift with the palette of public opinion. In the end, the truth will always stand out in its truest hue.