After push to remove artificial coloring, FDA approves 3 natural food dyes
The US Food and Drug Administration has approved three new color additives from natural sources 'that will expand the palette of available colors from natural sources for manufacturers to safely use in food,' the agency said in a news release.
The three dyes are Galdieria extract blue, butterfly pea flower extract and calcium phosphate.
US Department of Health and Human Services Secretary Robert F. Kennedy Jr. has made phasing out petroleum-based dyes in the nation's food supply one of the priorities in his broader initiative to 'Make America Healthy Again.'
Artificial food dyes are facing new restrictions or bans at both the federal level and in more than half the states. In April, FDA Commissioner Dr. Marty Makary announced the agency would work with the industry to remove and replace the dyes, though the FDA largely hasn't yet made this a requirement for industry.
'For too long, our food system has relied on synthetic, petroleum-based dyes that offer no nutritional value and pose unnecessary health risks,' Kennedy said in a news release. 'We're removing these dyes and approving safe, natural alternatives — to protect families and support healthier choices.'
Galdieria extract blue derives from Galdieria sulphuraria, a type of red algae that carries a water-soluble blue pigment known as C-Phycocyanin and is found in acidic volcanic hot springs and calderas, according to the FDA and Fermentalg, a French chemical company using micro-algae for colorants, foods and supplements.
Fermentalg sought approval for the additive for foods and beverages via a petition it submitted to the FDA in 2021 and has patented a Galdieria sulphuraria extract under the name Everzure.
Galdieria sulphuraria's natural ability to reside in acidic environments lends to its stability in food and beverages, which is something food and beverage manufacturers have been concerned about in the shift to natural alternatives to highly stable artificial dyes.
Butterfly pea extract is a blue color from which manufacturers can create a range of shades including bright blues, intense purples and natural greens, according to the FDA. It's produced from the water extraction of the dried flower petals of the butterfly pea plant, and is already approved for some uses, including sports drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, candy and ice creams.
Its use is now expanded to also include ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips and multigrain chips, the FDA said. The petition that raised this extract for consideration was submitted in February 2024 by the St. Louis-based Sensient Colors, one of the largest global dye-makers.
Calcium phosphate, a mineral compound containing both calcium and phosphorus, provides a white color newly approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar and sugar for coated candies, according to the FDA, whose decision approves a 2023 petition filed by New Jersey-based Innophos Inc., a mineral solutions company.
'The FDA determines whether an additive is safe to use by considering the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information, such as published literature,' the agency stated in a news release.
The embrace of natural dyes is due to health concerns around artificial colorants, such as increased risk of cancer and neurobehavioral issues. While some manufacturers acknowledge these concerns, they have also highlighted the challenges involved in an industrywide shift to alternative dyes, which is likely due to both state-level bans and the FDA's requirement that food companies remove red dye No. 3 — banned in January — from foods by January 15, 2027.
'Natural colors can be more expensive from a cost-in-use perspective depending on the raw ingredient being used,' Amy Agallar, vice president of investor relations and treasurer at Sensient, said via email May 2. 'The raw ingredients can vary due to many factors such as availability, time to harvest and color availability from the raw material. The natural color needed to replace a synthetic color can be ten times that of a synthetic product.'
That discrepancy is partly due to some food and beverage products requiring heat processing or acids that affect the stability of natural colors, Agallar added. 'Some natural colors are also not very light stable and this may be needed in the end application.'
Additionally, 'studies show that customers prefer products with color and are more likely to purchase food and beverages with a color that matches the expected flavor,' Agallar said. 'Consumers use the color to identify how a product will taste. Food manufacturers currently use natural color products in about 80% of new colored food and beverages released in the US each year.'
There's little funding for research on artificial food dyes, and even less for the study of emerging alternatives — so it's not yet known whether these new natural dyes could have any effect on human health. But with most natural dyes coming from plants and being used in small quantities, 'it's hard to believe they'd have any effect' on the general population, Dr. Marion Nestle, Paulette Goddard Professor of Nutrition, Food Studies, and Public Health, Emerita, at New York University, told CNN in a previous story.
Sensient has developed its own safety program, Certasure, Agallar said. 'This program ensures that our natural colors are free of pesticides, heavy metals, microbiological contamination, adulteration, and unauthorized solvents.'
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Scientists Are Afraid of What RFK Jr. Means for Autism
The annual meeting of the International Society for Autism Research is the closest autism science gets to having an Oscars moment of its own. When 2,200 experts from more than 50 countries meet up in one place—as they did this spring in Seattle—a kind of brainy excitement pervades, not just because of the awards given out (yes, awards are given out) or the chance for up-and-comers to network with top names in autism research, but also because there's always something to celebrate in the science itself. For two decades, studies presented at INSAR have shaped the world's understanding of autism. The buzz at the conference comes from the conviction that the work matters and that progress continues, sustained by an optimism that no nonscientist could undo. With one possible exception: U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. In April, shortly before the conference, Kennedy announced a major research undertaking. He promised that his agency would determine the cause of autism—or, at least, have ' some of the answers '—by September. (He soon extended the timeline into next year.) The effort, he pledged, would employ 'the most credible scientists from all over the world.' Now here those scientists were, all in one place. But none of those we spoke with had received the call to help, nor did they expect to. In speeches and interviews as health secretary, Kennedy has made clear his disdain for mainstream autism research, brushing aside the insights gained for this tremendously complex condition through years of research. Instead, backed by the enormous power of his federal office, Kennedy now appears determined to pursue his own long-held set of theories about autism: first, that we are in the midst of an autism epidemic (which is, in fact, highly debatable); second, that autism is caused by one or more 'environmental toxins' (which incorrectly suggests that environmental factors have not been explored); and third, that powerful interests want this information covered up (a conspiracy-esque viewpoint that lacks evidence). 'The way the secretary characterizes autism research,' David Amaral, the research director at the MIND Institute at UC Davis and one of INSAR's co-founders, told us, 'it's as if nobody's been doing anything for the last 30 years.' Amaral was one of more than a dozen veteran researchers we met with over the four-day conference, whose faces all went dark anytime we asked about the impact of Kennedy's muscling into their domain. They have been witnessing the health secretary bend the narrative of autism science in America. Their shared assessment: What he's doing is not good. The problem begins, in the researchers' view, with Kennedy's grasp of the science, which they say he either doesn't understand or refuses to acknowledge. For instance, Kennedy has complained that too much money has been spent studying genetic causes of autism, describing this avenue as 'a dead end.' Between sessions at the conference, the geneticist Joseph Buxbaum sat with us in an empty meeting room and sketched out on a piece of cardboard the numbers and timeline that demonstrate all that's wrong with this viewpoint. Autism's genetic underpinnings were first uncovered through studies of twins in the 1970s. Access to the human genome has now revealed that about 80 percent of the odds of being autistic are rooted in heritability. At INSAR this year, one of the most optimistic presentations focused on the progress being made toward genetics-based treatments. 'It is shocking,' Buxbaum said of Kennedy's apparent disregard for experts' input. Compounding the situation are the Trump administration's blitz of DEI-focused executive orders and DOGE cuts, which are undermining autism research. The Autism Science Foundation has been circulating a questionnaire asking researchers to report funding lost this year. Dozens of responses have been received, so far adding up to more than $80 million worth of halted research and pending grants that now will not come through. Jobs have been lost. Future discoveries have been postponed, possibly for good. Emily Hilliard, a spokesperson for HHS, told us in an email that Kennedy's team is 'fully committed to leaving no stone unturned in confronting this catastrophic epidemic—employing only gold-standard, evidence-based science.' It's unclear just whom Kennedy is relying on for scientific expertise; Hilliard did not address a request for more information about the scientists involved in the health secretary's initiatives. But Kennedy's singular view on the actual expert consensus seems driven by a personal goal: to implicate vaccines as the cause of autism. He now has reshuffled the ranks of the CDC's vaccine-advisory committee to include scientists who lack expertise on vaccines and have shared anti-vaccine views, and he has reportedly appointed the son and frequent collaborator of an anti-vaccine activist—one who long promoted false ties between vaccines and autism—to begin examining federal databases for evidence of such a link. Kennedy has long been a prominent advocate of this false conviction. A quarter century ago, the now-discredited British researcher Andrew Wakefield claimed to have discovered a temporal association between administration of the MMR (measles, mumps, rubella) vaccine and the onset of autistic symptoms in young children. Thus began a self-perpetuating cycle. The greater the number of parents who decided to refuse the MMR vaccine, the more the news media saw a valid trend story. Only four months after Wakefield published in The Lancet, MMR vaccinations had dropped almost 14 percent in South Wales. The fear soon crossed the Atlantic, and Kennedy himself brought further mainstream attention to the issue in 'Deadly Immunity,' a 2005 article for Rolling Stone and Salon. (Both publications later retracted the story.) Books were written about the supposed danger. Documentaries were made. Protests were held. It's hard to remember now, but up until that time, most people had never heard of autism. Almost overnight, parents everywhere became scared of the word, and scared of what a doctor's needle might mean for their child. This fear had obvious downsides—the stigmatization of autistic people as being 'damaged,' a drop in vaccine uptake broadly, a loss of faith in science, and a sense that something dangerous had been let loose upon the population and especially children. But something constructive came from all the attention to the issue as well. Parent activists jumped on it to pressure Congress to start funding autism research. The money began flowing in earnest in 2006, with a five-year $945 million allocation, and has since reached a total so far of roughly $5 billion, funding university labs and research centers around the U.S. The investment paid off: Autism became better understood. The vaccine question was a top priority out of the gate, and epidemiological research found repeatedly, exhaustively, and emphatically that vaccines do not cause autism. Clearly, however, RFK Jr. is not satisfied. When Kennedy speaks today about autism, it's as though the past 20 years never happened. It's not just about the canard that is being resuscitated. It's the language he uses to talk about what he thinks being autistic means. At a press conference in April, he set off a firestorm in autism communities when he described children with autism as 'kids who will never pay taxes. They'll never hold a job; they'll never play baseball; they'll never write a poem; they'll never go out on a date. Many of them will never use a toilet unassisted.' Tragedy framing, sorrow inducing—this echoes the 20th-century take on autism, when people with the diagnosis were too often treated as not fully human. Many were subjected to abuse and isolation (often by being institutionalized). After Kennedy received some blowback for his comments, he clarified that he was talking specifically about children on the severest end of the spectrum. Hilliard, the HHS spokesperson, told us that Kennedy 'remains committed to working toward a society where people with autism have access to meaningful opportunities, appropriate supports and the full respect and recognition they deserve.' She said his statements aimed to emphasize 'the need for increased research into environmental factors contributing to the rise in autism diagnoses, not to stigmatize individuals with autism or their families.' Nevertheless, the damage was done. Regardless of his intention, the ways Kennedy speaks about autism seem to miss how, for many, the prevailing narrative has moved on to more human framing, in which autism is not a disease or a tragedy but a difference meriting acceptance and support. His bleak terminology—autism is 'a disease'; it 'destroys families'; 'we need to put an end to it'—has left a mark. Amy Gravino, who is autistic and specializes in sexuality and relationship coaching, told us she felt shattered by Kennedy's comments. 'For the last 20 years, we as a community have fought against the rhetoric that RFK is now spouting,' she said. 'Everything we have tried to do to humanize autistic people has been potentially wiped away in one fell swoop.' Many parents, too, took offense at RFK's flattened portrait of their autistic children as a collection of problems and nothing more. The depiction leaves out everything about these children's worth as people: their capacity for joy, love, and creativity; their inherent dignity. 'If the world uses a lens that is only based on deficits and struggle rather than the complexity and nuance that is a part of any human being, including and especially autistic people, that makes true belonging really hard,' Sara Swoboda, a pediatrician in Boise, Idaho, whose daughter has an autism diagnosis, told us over email. At the INSAR conference, a pediatrician alerted us to concerns spreading among parents about Kennedy's plans to create a 'data platform' for autism. So far, the National Institutes of Health, the agency overseeing the platform, has outlined this project only vaguely, including that it would involve scraping data from all over the digital landscape—from Medicaid claims, private-sector health records, pharmacy chains, insurance billings, and even smartwatches and fitness trackers. It has not gone over well. The pediatrician shared some of the texts she has been getting from contacts around the country reporting that parents of autistic children were calling their health-care providers and pleading with them to scrub references to autism from their kids' medical records. Other parents waiting for assessments for autism were calling in to cancel. When we contacted nearly a dozen doctors and advocates about this matter, they confirmed getting similar requests from parents in their practices and communities. 'People are freaking out, and I don't blame them,' Alycia Halladay, the chief science officer for the Autism Science Foundation, told us. 'For the government to come in with no transparency and say we have the authority to take this data, that is scary to people.' They're scared of lost privacy, of seeing their kids stigmatized, of consequences related to insurance and job discrimination. But in a bigger sense, they don't want their kids marked, and scared of a comeback for those old attitudes about autism. Data collection in itself need not be a source of panic. It is, after all, the currency of epidemiology. It's how the vaccine theory was debunked and how the CDC determines prevalence rates. Usually, methods are put in place to ensure anonymity and ethical disbursement of the data. Hilliard told us that 'all NIH-managed databases follow the highest standards of security and privacy, with the protection of personal health information as a top priority.' Even if there's nothing to fear about this new database, however, good results in science depend on trust. That trust now appears to be at risk. Not everyone thinks Kennedy is getting every part of the story wrong. His clumsily calibrated messaging, though offensive to many, was appreciated by some families who feel seen by the secretary for addressing a segment of the autistic population that still gets minimal attention. These are people whose challenges range from moderate to severe and who, as Kennedy acknowledges, will never achieve real independence. The most challenged—assessed at roughly 27 percent of the autistic population in a 2023 study—are people with IQs below 50 or whose ability in the use of spoken language is minimal to none. Some in this group can also be violent toward themselves, and their inability to understand danger has resulted in their deaths with shocking frequency. They are people who require round-the-clock supervision, Especially for the families of such individuals, there is a deep frustration that most people no longer associate autism with individuals like their kids. Theirs is not the popular autism story. They get little interest from Hollywood, which best likes narratives about autistic people as fundamentally quirky or brilliant. Science hasn't shown much interest either, especially social science, whose practitioners find it easier to study people who can hold a conversation and complete a questionnaire. Additionally, parents who risk sharing details of the struggles at home can end up feeling like they've violated some sort of taboo, facing social-media pile-ons in which they're accused of dehumanizing their children by being explicit about autism's downsides. Kennedy was explicit about the downsides. In response, Amy Lutz, a medical historian and the vice president of the National Council on Severe Autism, wrote an article titled ' RFK Was Right: Severe Autism Can Be Devastating.' Lutz is the mother of an adult autistic man. She argues that Kennedy definitely gets a lot wrong about autism (for example, vaccines), but at least he is 'shining a light on the segment of the autism spectrum that has been increasingly marginalized by a focus on the most capable.' During our last full day at INSAR, we attended a luncheon sponsored by an advocacy organization called Profound Autism Alliance. Seated around three long tables was a group of psychiatrists, psychologists, pediatricians, and educators all involved in serving the marginalized 27 percent. That morning, they had witnessed a milestone in their field: A presentation at the conference had called for formal recognition and definition of profound autism as a new diagnostic category. (How widely this framing will gain acceptance remains to be seen.) Kennedy had no involvement in the presentation, but we asked the group about the health secretary's role in bringing attention to the profoundly autistic. There was, at best, some grudging acknowledgment that he had done so. But the researchers—whom we agreed not to name so they could speak without fear of professional repercussions—were much more concerned about the harm they feared Kennedy is doing, and will do, by parachuting, uninvited, into their realm. The risk, they said, is not just the harm to science, or potentially to their own work or the careers of those just starting out who may now choose something 'not autism' to work on. All of that, they told us, is secondary to the potential harm to autistic people and to those who know and love them. If faulty science takes charge and finds a cause that isn't a cause—such as vaccines—it will imply that the easy next step is finding the antidote to the cause. That is a seriously problematic proposition. For one thing, many diagnosed people say they have no interest in becoming un autistic. For another, a one-and-done remedy for the condition's most debilitating manifestations is, quite simply, a phantom goal. As anyone who has seriously studied autism will tell you, the condition is too complex. As one pediatric neurologist at the profound-autism luncheon put it, 'If I had that magic pill, don't you think I would give it to you?' There is no magic in science, which is why so many researchers think Kennedy's approach is an exercise in false hope. One thing the neurologist knows after years of treating children herself, she told us, is 'there's nothing worse for a family than to be given false hope.'
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By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) posted a flurry of press releases last week announcing the submission of its new drug application (NDA), a partnership with Omnicom for cytisinicline commercialization, a proposed public offering and the pricing of the offering. The capital raise was closed on June 30th. This is the culmination of more than a decade of work developing cytisinicline for smoking cessation. Now that the development phase of cytisinicline for smoking cessation is coming to a close, we look towards the regulatory and commercialization phases. We expect to see the FDA formally accept the NDA by late August and Achieve's management team to turn its attention towards the sales effort. Assuming normal turnaround times, we expect the FDA to set a target action date sometime in 2Q:26. NDA Submission Achieve announced its NDA submission of cytisinicline for smoking cessation in a June 26th press release. The company conducted two Phase III studies, an open label safety study and other studies that evaluated over 2,000 participants with the results demonstrating the safety, efficacy and tolerability of cytisinicline. We expect to see acceptance of the NDA within 60 days and further expect additional safety data from the ongoing ORCA-OL trial to be shared with the agency near year end. Commercialization Partnership Now that the new drug application has been submitted, Achieve is further advancing its commercialization efforts. During its earnings calls, the company has outlined its commercialization strategy and is now partnering with Omnicom Group to execute the plan. Omnicom Group provides brand and advertising services to thousands of clients globally and is one of the world's largest advertising and marketing services companies. Achieve will work with Omnicom subsidiary Credera, which is focused on digital transformation services. Credera combines consulting, artificial intelligence (AI) and technology expertise to build consumer technology platforms, integrate marketing technology systems and provide strategic consulting services. It will help Achieve to precisely target and engage healthcare professionals and patients through optimization of channel performance and acceleration of meaningful engagement. The team executing the initiative will include Goodby, Silverstein & Partners, DDB Health, and Ketchum Health which are health care-focused subsidiaries of the Omnicom marketing group. The various subsidiaries will provide expertise in consumer brand development, medical education and strategic public relations and communications, applying industry insights to support cytisinicline launch. In the Achieve partnership, Ketchum Health brings public relations and communications expertise, while Credera handles technology, Goodby Silverstein provides creative advertising, and DDB Health focuses on healthcare marketing. The partnership will use generative AI, predictive analytics and social listening to enhance targeting and personalization. Using a comprehensive approach, it will also employ healthcare applications, pharmacies and data providers to expand the reach and depth of insights. Omnicom has worked as media agency, digital and brand experience for other pharmaceutical and biotechnology clients including established firms such as AbbVie, AstraZeneca, Novartis and Moderna among others. Achieve will be the first small company that Omnicom has supported in commercializing a newly approved drug. Therefore, Omnicom will take on a broader strategic role than in its past partnerships. The Omnicom team will help communicate the optimal message to the provider and patient and monitor its effectiveness in real time. This will allow for rapid course corrections and focus on high value activities. Achieve has identified several target groups for its marketing efforts that are stratified by age, social media use and other demographic data. It was able to identify these groups based on subject experiences in the company's many clinical trials. We anticipate that the structure of Achieve's internal marketing team will be heavily tilted toward supporting the digital campaign with contract representatives available for in-person physician meetings when appropriate. Public Offering On June 30th, 2025 Achieve closed its $45 million capital raise. 15 million shares were issued at $3.00, each of which included an attached warrant exercisable at $3.00 per share. An additional 1,766,666 warrants were issued upon the partial exercise by the underwriters of their option to purchase additional shares, bringing total issued warrants to approximately 16.8 million. Net proceeds from the capital raise are estimated to be $41.3 million as disclosed in the June 27th Form 8-K filing. ORCA-OL Safety Trial Achieve began 2025 by announcing that 300 participants had completed six months of treatment in the Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial. The Data Safety Monitoring Committee (DSMC) identified no safety concerns as of this milestone allowing registrational filing with the FDA. As of May 2025, a third DSMC safety review was completed which also found no unexpected treatment-related adverse events. As of the first quarter reporting date, more than 100 subjects had completed one year of cytisinicline treatment. Furthermore, about 75% of the 479 (~360) individuals remained on treatment in the trial. We think that it is a material real-world positive that so many participants would remain on a smoking cessation product for that long a period suggesting that cytisinicline is well tolerated. This is particularly notable given the high discontinuation rates for Chantix and the associated unpleasant side effects such as nausea, headache, abnormal dreams and constipation.[1] Achieve expects to complete the one-year safety data package in the next few months and will submit this to the FDA by the 120-day safety review milestone. This should be around year-end 2025. Achieve expects that it will far exceed the 100-patient minimum required for one year of safety observations and could see as many as 300 patients with one year of exposure. Since one of the secondary endpoints is efficacy, this study should be able to show a wealth of data that can help providers use cytisinicline more effectively especially in chronic areas of disease such as Chronic Obstructive Pulmonary Disease (COPD) and cardiology. Milestones Development of cytisinicline product label for smoking cessation – 1H:25 Completion of six months of ORCA-OL safety data for 300 subjects – January 2025 Attendance at Oppenheimer Healthcare Life Sciences Conference, Virtual – February 2025 Attendance at Barclays Healthcare Conference, Miami – March 2025 Selection of 3rd party logistics partner – 2Q:25 NDA Submission – 2Q:25 FDA data submission from patients with twelve months of exposure to cytisinicline – 4Q:25 Launch of Phase III vaping trial – 1H:26 FDA target action date for cytisinicline NDA – 1H:26 Launch of cytisinicline – 3Q:26 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer . ________________________ [1] Minian, N., et al. Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review. BMC Public Health. March 2024.
