Food and Drug Administration

The Food and Drug Administration is investigating a multi-state outbreak of infant botulism linked to recalled baby formula. Infant botulism is a rare but serious illness caused when babies consume bacteria with spores that produce a toxin in the gut.

A secret shopper study revealed that telehealth sites prescribing GLP-1 medications for weight loss often operate with minimal clinical oversight, enabling fast and easy access to drugs like semaglutide and tirzepatide. The study, conducted by a Yale researcher and published in the Journal of the American Medical Association, highlights concerns about virtual care practices and the market for non-FDA-approved compounded versions due to shortages.

A voluntary recall has been issued for specific lots of Oribe Serene Scalp Densifying Shampoo after the detection of Pluralibacter gergoviae bacteria, which can cause infections. The recall includes 8.5 oz and 33.8 oz sizes manufactured between February 21, 2026, and February 26, 2026. Kao USA advises consumers to stop using the affected products and provides contact information for replacements.

Oribe Serene Scalp Densifying Shampoo is being voluntarily recalled due to the presence of Pluralibacter gergoviae bacteria, which can cause infections. The FDA warns the bacteria poses higher risks for individuals with weakened immune systems. Kao USA urges consumers to stop using specific 8.5 oz and 33.8 oz lots manufactured between February 21, 2026, and February 26, 2026.

A Utah-based AI prescription refill program using chatbot Doctronic has sparked debate over AI's role in medicine, with doctors and experts raising concerns about regulation, safety, and legal oversight. The program, operating under a state regulatory sandbox, initially involved human review of AI-generated refills but plans to transition to full automation, prompting criticism from medical licensing boards.

A 15-year-old girl died after attempting the viral 'Benadryl challenge,' which involves taking excessive doses of the medication to get high. Her father, Richard Presson, described the tragic outcome and urged parents to monitor online trends, citing warnings from the FDA about the dangers of high-dose Benadryl use.

A 15-year-old girl died after participating in the viral 'Benadryl challenge,' a dangerous trend involving excessive medication use. Her father, Richard Presson, described her rapid decline and urged parents to monitor online trends, as platforms like TikTok and YouTube have policies against promoting harmful challenges.

A 15-year-old girl died after participating in the viral 'Benadryl challenge,' which involves taking excessive doses of the medication to get high. Her father reported she lost all brain function and required a ventilator before her death, while TikTok and YouTube stated they remove content promoting dangerous challenges.

Americans are increasingly using peptide compounds for health and performance from unregulated sources, creating risks. The FDA, led by Kyle Diamantas, has an opportunity to regulate peptides without resorting to a crackdown or uncontrolled access.

Recent recalls of multiple infant formula brands due to bacterial contamination have raised concerns about the FDA's preparedness, attributed to staff cuts under the Trump administration. The FDA launched Operation Stork Speed to address formula shortages, but Martin Makary, FDA commissioner at the time, cited a loss of 3,100 employees from Trump-era reorganization and cuts.

Multiple brands of infant formula have been recalled due to bacterial contamination, with experts citing inadequate FDA preparedness linked to Trump administration staff cuts. The FDA launched Operation Stork Speed to address formula shortages, but former FDA commissioner Martin Makary noted a loss of 3,100 employees from reorganization and cuts before his departure.

Medical professionals and police departments are warning against the resurgence of the Benadryl Challenge, which involves taking large doses of Benadryl to induce hallucinations. The practice has led to serious health risks, including seizures, irregular heart rhythms, and deaths, with reports of three children in Connecticut and a 15-year-old in Oklahoma dying from diphenhydramine overdoses.

The FDA upgraded Utz's potato chip recall to the highest risk level (Class I) due to Salmonella concerns. Over 650,000 bags of chips were recalled, initially started on May 5, and later classified as the most severe risk by the FDA.

A mother accused Mead Johnson's infant formula of causing her son's death from necrotizing enterocolitis (NEC), but the company concluded in an internal memo that the formula was not likely responsible. Mead Johnson closed the case without further investigation, and the FDA found no record of manufacturers reporting infant deaths linked to formula under regulatory requirements.

UpDoc, a digital health company, received the first FDA clearance for medical software using patient-facing large language models (LLMs) in its diabetes management app. The app, which helps patients follow doctor-defined treatment plans, uses an LLM-based interface to provide treatment instructions based on user inputs like voice and text.

Tala Fakhouri, who previously worked at the FDA on AI policy, now at Parexel, criticizes the biopharma industry for misinterpreting the FDA's flexible guidance in conservative ways to avoid risk. The article highlights concerns about how industry implementation diverges from the FDA's intended approach.

The Food and Drug Administration allows ZYN nicotine pouches to be marketed as less harmful than cigarettes. Child psychologist Bonnie Halpern-Felsher discusses the risks of ZYN and other nicotine pouches for young people.

Tennessee's new kratom ban, effective Wednesday, has sparked concerns among overdose prevention advocates and addiction experts who warn it could lead to increased overdoses as users turn to more dangerous alternatives. The law criminalizes possession and sale of kratom, including synthetic forms, and joins six other states with similar bans, despite some users relying on it to manage opioid addiction.

A record-breaking heat wave is causing dangerous temperatures in the central and eastern U.S. The FDA approved Zyn nicotine pouches to be marketed as less harmful than cigarettes. U.S. diplomats arrived in Qatar for indirect talks with Iranian officials.

The FDA has permitted Zyn nicotine pouches to be advertised as less harmful than cigarettes. This decision allows the product's marketing to highlight reduced health risks compared to traditional cigarettes.

The FDA has permitted Zyn nicotine pouches to be marketed as less harmful to human health than cigarettes. This decision allows the product to be advertised with reduced harm claims relative to traditional cigarettes.

The Food and Drug Administration is meeting next month to consider easing restrictions on several peptides, a group of unapproved drugs popular with followers of Robert F. Kennedy Jr. The agency posted meeting materials online Monday.

The FDA's upcoming peptide safety review panel includes health professionals with financial ties to the peptide industry, a shift from previous academic-focused panels. The meeting, influenced by Health Secretary Robert F. Kennedy Jr.'s 'Make America Healthy Again' movement, will assess peptides like BPC-157 and TB-500, which the FDA has warned are unproven and risky.

The FDA has recalled nearly 1 million bottles of kidney and heart medications Corlanor (ivabradine) and Sensipar (cinacalcet) distributed by Amgen Inc. The recall for Corlanor is due to a foreign substance, while Sensipar's recall stems from CGMP deviations. The FDA noted the risk to patients is low.

The FDA announced eight new panelists to advise on regulations for compounding pharmacies manufacturing peptides. Most panelists are linked to businesses promoting peptides, and one, Bobby Harshbarger, is a pharmacist and Tennessee state senator. A professor raised concerns about the panelists' ties to unproven peptide and stem cell treatments.

The United States is concerned about losing ground to China in clinical research but argues that prioritizing trial reform as a race may overlook the goal of creating a faster, safer, and more trusted model for medicine development. The Food and Drug Administration (FDA) is highlighted as a key player in this context.

The FDA has issued a Class I recall for 684,248 bags of Zapps and Dirty brand potato chips due to potential Salmonella contamination linked to a seasoning containing dry milk powder. Utz recalled the products as a precaution despite the seasoning testing negative for Salmonella, advising consumers to discard affected batches.

The FDA will hold a meeting in July to discuss easing restrictions on research peptides, which are currently sold in a gray market with limited safety and efficacy evidence. If restrictions are relaxed, US compounding pharmacies could legally produce and fill prescriptions for these peptides.

Eli Lilly's obesity drug retatrutide is being made available to one individual through the FDA's 'compassionate use' program. The article discusses this development alongside broader questions about drugmaker acquisitions and the investment potential of hair loss drugs, as covered in a podcast episode.

Regenxbio announced it will submit its Duchenne muscular dystrophy gene therapy for accelerated approval, despite the FDA previously requesting an additional trial. The FDA appears to be reversing recent rejections of gene therapies, including a Hunter syndrome treatment reconsidered after key officials, Marty Makary and Vinay Prasad, left the agency.

LivaNova's VITARIA vagus nerve stimulator for heart failure, designated a FDA breakthrough device, failed to meet trial success criteria after enrolling 500 patients. The FDA's breakthrough device program, aimed at accelerating innovative treatments, did not ensure the device's market success.

The FDA notified wearable company Whoop that it would not pursue further enforcement against its Blood Pressure Insights feature after the company made adjustments. In July 2025, the FDA warned Whoop for releasing the feature without clearance, arguing it functioned as an unapproved medical device. Whoop claimed the feature was intended for wellness use, not medical diagnosis, and its CEO criticized regulatory overreach.

MorningStar Farms recalls two plant-based products due to potential plastic contamination. The FDA advises against consuming the affected items, and the company offers refunds.

The FDA recalled 11,460 bottles of 25mg chlorthalidone tablets due to failing dissolution specifications, distributed by Rising Pharma Holdings. The Class II recall indicates potential temporary adverse health effects.

EchoNext, an AI model developed by New York-Presbyterian Hospital researchers and commercialized by Pathway Labs, has received FDA clearance to detect seven forms of structural heart disease from EKGs. Pathway Labs will license the technology to OpenEvidence, a medical evidence search engine used by hundreds of thousands of clinicians.

The FDA recalled 11,460 bottles of chlorthalidone tablets due to potential ineffectiveness from failed dissolution specifications. The affected batches are RISA24001 (100-tablet bottles) and RISB24002 (1,000-tablet bottles), with an expiration date of April 2027. The medication is used to treat high blood pressure and fluid retention from conditions like heart failure, liver disease, kidney disease, or steroid treatments.

The FDA recalled 11,460 bottles of chlorthalidone tablets, 25 mg, due to potential ineffectiveness caused by failed dissolution specifications. The affected batches are RISA24001 (100-tablet bottles) and RISB24002 (1,000-tablet bottles), with an expiration date of April 2027. Chlorthalidone is a diuretic used to treat high blood pressure and fluid retention.

The FDA recalled 11,460 bottles of chlorthalidone tablets due to potential ineffectiveness caused by failed dissolution specifications. The affected batches include 100-tablet bottles (batch RISA24001) and 1,000-tablet bottles (batch RISB24002) with an expiration date of April 2027. Chlorthalidone is a diuretic used to treat high blood pressure and fluid retention.

The FDA will reconsider approving Regenxbio’s gene therapy for a rare childhood brain disorder, mucopolysaccharidosis type II (MPS II), after initially rejecting it four months ago. This follows recent FDA reversals, including allowing UniQure to resubmit a gene therapy application for Huntington’s disease previously rejected by former commissioner Marty Makary.

The Food and Drug Administration's top vaccine advisory committee unanimously recommended the first mRNA influenza vaccine. It uses the same technology as the COVID-19 shots.