This Week at FDA: FDA revokes food standards, says no to WHO pandemic regulation, and more

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, the Food and Drug Administration (FDA) said it is revoking dozens of food standards, the US government rejected a regulation from the World Health Organization (WHO) that it says would impose on its sovereignty during future pandemics, and CDER Director Vinay Prasad justified mRNA COVID-19 vaccine labeling changes.

FDA made several big announcements on the food regulatory side this week, including an announcement that it is revoking, or proposing to revoke, 52 food standards that it concluded are obsolete and unnecessary. The agency said the decision is part of its ongoing review of over 250 food Standards of Identity (SOI) to determine if the current standards are useful, relevant, and serve consumers.

Over the past few months, the Department of Health and Human Services (HHS) and FDA have been working to persuade food producers and drug makers to replace synthetic dyes with natural dyes. This week, the agency announced it has granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use gardenia (genipin) blue for foods. Since May, the agency has also approved galdieria extract blue, calcium phosphate, and butterfly pea flower extract as food dyes.

FDA said it had also sent a letter to manufacturers to encourage them to phase out the use of Red No. 3 faster than the originally proposed 15 January 2027 deadline set by HHS Secretary Robert Kennedy Jr. The agency said that the food and beverage trade association Consumer Brands has encouraged its members to phase out synthetic food dyes from school products by the beginning of the 2026–2027 school year.

Politico reported that FDA Commissioner Marty Makary spoke at the Reagan-Udall Foundation annual meeting, where he said the agency's recent hiring push came after “a lot of early retirements.” The statement came just after potentially thousands of FDA employees were finally and officially severed as part of the Trump Administration’s reduction in force efforts. “We’ve posted hundreds and hundreds of new positions, and we’ve got over a thousand applications so far,” Makary told the audience.

FDA noted that last week, the Customs and Border Patrol (CBP) announced it had rescinded FDA's review exemption for certain imported low-value FDA-regulated products. As a result, the agency said that all regulated imported products must now be reviewed.

"Previously, certain FDA-regulated products could be released by CBP without FDA notification, if eligible for exemption," FDA said in an email to stakeholders. "Now, because technological capabilities of both the trade and the FDA have advanced significantly, it is necessary that even low-value entries ($800 or less) undergo FDA review to ensure they comply with FDA requirements.

"We anticipate that this decision will improve supply chain oversight, improve public health protection, and identify repeat offenders that are deliberately trying to evade FDA evaluation," the agency added.

Kennedy and Secretary of State Marco Rubio issued a joint statement rejecting the 2024 International Health Regulations (IHR) Amendments by the World Health Organization (WHO). They argued that the international health body's regulation would infringe on US sovereignty by giving it the ability to order global lockdowns, restrict travel, and take other measures when responding to global public health risks.

“The proposed amendments to the International Health Regulations open the door to the kind of narrative management, propaganda, and censorship that we saw during the COVID pandemic,” said Kennedy in a statement. “The United States can cooperate with other nations without jeopardizing our civil liberties, without undermining our Constitution, and without ceding away America’s treasured sovereignty.”

In recent months, HHS, including FDA and the Centers for Disease Control and Prevention (CDC), has revised criteria for COVID-19 vaccination, as well as the evidence base needed for approval of COVID vaccines. In a viewpoint article published in JAMA, CBER Director Prasad detailed the rationale for the agency's recent Safety Labeling Change (SLC) for mRNA COVID-19 vaccines to include risks of myocarditis and pericarditis.

Drug & Biologics

FDA finalized guidance on conducting formal meetings between the agency and sponsors under the Biosimilar User Fee Amendments (BsUFA III). The guidance details good meeting management practices (GMMPs) and standardized procedures for requesting and conducting formal meetings.

Biocon Biologics announced FDA has approved its human insulin analog Kirsty (insulin aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to Novo Nordisk's NovoLog (Insulin Aspart). In astatement, FDA noted that it was the 72nd biosimilar product and the fourth biosimilar insulin product approved by the agency.

The FDA Office of Orphan Products Development (OOPD) has opened its Orphan Products Grants Program for stakeholders who want to conduct clinical trials of products with new indications or changes in labeling to address unmet needs in rare diseases. Stakeholders can apply for the grant program using the National Institutes of Health (NIH) website through 21 October 2025.

FDA announced that Nostrum Laboratories filed for Chapter 11 bankruptcy and closed its business, which resulted in discontinuing its quality activities. As a result, the company has issued a recall for its Sucralfate Tablets USP 1 gram because it can’t assure the quality of the drugs. The agency said that it only affects tablets made after June 2023 and does not affect other products.

Medtech

In an early alert from FDA, the agency said that BD and its subsidiary Carefusion have issued an Urgent Medical Device Recall letter for their Alaris Pump Module model 8100. It said that the devices do not perform as intended under certain conditions when used with a subset of compatible pump infusion sets. While the devices can continue to be used, users are being asked to take additional steps.

FDA also issued an early alert for certain B. Braun Medical microbore extensions that the company is withdrawing from the market because they include incorrect information about the device filter. The products are used for direct injection, intermittent infusion, continuous infusion, or aspiration of fluids, medications, blood, and blood products.

FDA added pediatric ventricular assist bypass products, also known as VAD, to its medical device shortage list (MDSL) and removed intra-aortic balloon and control system devices from the list. The agency added that shortage of VADs could mean changes in clinical treatment for children who need mechanical circulatory support.

Integra LifeSciences has issued a class I recall for some of its Codman disposable perforators and craniotomy kits after reports that they could come apart due to a manufacturing error. Use of the products could result in several types of adverse events, including brain damage and death, and users have been told to stop using them immediately.

This Week at FDA: FDA revokes food standards, says no to WHO pandemic regulation, and more

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