This Week at FDA: FDA takes aim at synthetic food dyes, OMB proposes reclassifying policy staff

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA and the Department of Health and Human Services (HHS) announced they want to phase out petrochemical-based food dyes, the federal government is looking to reclassify policy personnel, and HHS reversed course on cutting funding for the Women’s Health Initiative.

The Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) announced their intention to phase out petroleum-based food dyes.

Health and Human Services Secretary Robert Kennedy Jr. also hinted that the National Institutes of Health (NIH) would be looking into the safety of pharmaceutical additives. “We’re going to start on that next,” Kennedy said. He later said NIH is assembling teams “all over the country of scientists at universities and research centers to look at all of those products.”

“One of the problems is we don’t have good science on everything and we need to have science before we take policy action, and that science has been suppressed systematically for decades because of the conflicts in this agency. We’re going to remove those conflicts, we’re doing the science – already doing it – and I will be announcing a series of grant opportunities this summer on all of these different ingredients,” Kennedy said.

Kennedy, who was joined by FDA Commissioner Martin Makary and NIH Director Jay Bhattacharya announced they were taking several steps to transition the food industry from using petroleum-based food dyes to natural alternatives, though the agencies have not proposed any rule or regulation to do so and said they are relying on industry to voluntarily remove the ingredients from their products.

FDA said it will develop a national standard and timeline to make the transition happen, and in the next few months, the agency said it would also start the process to revoke authorization for Citrus Red No. 2 and Orange B food colorings.

“For the last 50 years, American children have increasingly been living in a toxic soup of synthetic chemicals,” said FDA Commissioner Martin Makary during a press conference at the Department of Health and Human Services (HHS) headquarters. “The scientific community have conducted a number of studies raising concerns about the correlation between petroleum-based synthetic dyes and several health conditions such as attention deficit hyperactivity disorder, obesity, diabetes, insulin resistance, cancer, genomic disruption, [gastrointestinal] issues as I've seen in the hospital, and allergic reactions.”

“We have to turn our attention to underlying causes such as chemicals and toxins that children are exposed to, not just more insulin and chemotherapy,” he added. “For the last 50 years, we have been running one of the largest uncontrolled scientific experiments in the world on our nation's children without their consent, and today we are removing these petroleum-based chemicals from their food supply.”

Makary noted that many of the food dyes that FDA is proposing to phase out are already banned in other countries, including members of the European Union.

“We are simply asking American food companies to replace petroleum-based food dyes with natural ingredients for American children just as they already do for children in other countries,” he added.

FDA said it will also eliminate the remaining six synthetic dyes, which include FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2, by year's end. Earlier this year, the Biden administration revoked the authorization for FD&C Red No. 3, requiring manufacturers to remove it from food and ingested drugs in early 2027 and 2028, respectively. Now, FDA said it will request food companies to remove the dye from their products more quickly, though it did not elaborate on how this accelerated timeline would be achieved.

FDA also said it plans to accelerate the review and approval of four new natural color additives over the next few weeks. More specifically, it is fast-tracking the review of natural food dye alternatives such as calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract.

During the press conference, Kennedy said he would restore all the Freedom of Information Act (FOIA) offices after FDA staff were fired during the recent layoffs. He also said the administration would create a website with all past FOIA requests and the documents produced so people wouldn’t have to make the same requests.

Axios reported that FDA's product databases, which include drug safety and manufacturing information, are being neglected due to the recent reduction in force (RIF). Agency officials are concerned that the lack of real-time information in the databases, including adverse events, quality problems, and drug shortages, could pose serious public health risks.

Axios also reported that Kennedy will testify before the Senate Health, Education, Labor, and Pensions (HELP) Committee in mid-May on the RIF layoffs and their effect on HHS. He had initially been asked to testify on 10 April.

The Office of Personnel Management (OPM) has proposed a rule furthering President Donald Trump's executive order to reclassify policy-influencing employees into Schedule Policy/Career positions. If finalized, the rule would mean they would be considered at-will employees who could be removed from their position more easily.

Democratic House leaders on the Appropriations Committee have scheduled a hearing on 29 April with public health experts to discuss how the Trump administration's RIF and other efforts have affected the Centers for Disease Control and Prevention (CDC). Anne Schuchat, former CDC principal deputy director, is among the experts invited to speak at the hearing.

Science Magazine reported this week that the National Institutes of Health canceled the Women's Health Initiative, the largest research database of its kind, including data from tens of thousands of women for over thirty years. However, after significant pushbacks, the administration announced it has decided to reverse course.

FDA announced three leadership hires this week, including naming Lowell Zeta as the new deputy commissioner for strategic initiatives, Timothy Schell as acting director of the Center for Veterinary Medicine, and Craig Taylor as the FDA acting chief information officer. Despite the announcement, the agency has not updated its leadership page.

Drugs & Biologics

Hong Kong-based Akeso Biopharma's differentiated PD-1 monoclonal antibody has been approved as first-line treatment for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adults by FDA. The drug was also approved to treat adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

FDA said it has received reports of adverse events associated with the use of compounded topical finasteride, which are often obtained through telemedicine services. The side effects include erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain, which are similar to those reported for approved oral versions of the drug. The agency said consumers should be educated on the potential side effects of the drugs and noted there are only two FDA-approved oral finasteride products on the market.

Amneal Pharmaceutical has recalled two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, infusion bags due to concerns they may contain inert fiber identified as polypropylene fibers from the IV bag. The company said the particulates could cause meningitis or damage the spinal cord.

Medtech

Q’Apel Medical has issued a class I recall for its neurovascular 072 Aspiration System, also known as Hippo. The company discontinued the devices after receiving a warning letter from the FDA due to concerns that the distal tip of the Hippo aspiration catheter did not meet its 510(k) clearance requirements. The company has investigated the distal tips and said they likely contributed to several adverse events.

FDA said it has received reports that ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems could produce false positive results that could overestimate blood lead levels from capillary blood samples. The agency asked healthcare providers and laboratory staff not to use the products while it investigates the cause.

FDA has issued an early alert for BD and its subsidiary Bard Access Systems' PowerPICC Intravascular Catheters due to concerns that material fatigue leaks could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection, and treatment interruption. The company has sent letters to users who may have been affected, not to use the products, and updated instructions for use for 4 Fr. Single Lumen PowerPICC, and SOLO and non-SOLO versions.

This Week at FDA: FDA takes aim at synthetic food dyes, OMB proposes reclassifying policy staff

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