U.S. Food and Drug Administration
Coverage of U.S. Food and Drug Administration in the Nexus archive.
- US Food and Drug Administration rejects petition to set Pfas limits in food
The US Food and Drug Administration rejected a petition to set limits on toxic PFAS 'forever chemicals' in food, despite the Environmental Protection Agency identifying food as the largest source of PFAS exposure. Testing revealed some contaminated foods contain PFAS levels equivalent to drinking multiple glasses of contaminated water.
- US Food and Drug Administration rejects petition to set Pfas limits in food
The US Food and Drug Administration rejected a legal petition to set limits on toxic Pfas 'forever chemicals' in food, despite the Environmental Protection Agency identifying food as the largest source of Pfas exposure. Testing has shown some contaminated foods contain Pfas levels comparable to drinking multiple glasses of contaminated water.
- What to know about cyclospora and how to avoid it
Cyclosporiasis cases are surging in Michigan, Ohio, and New York, with Michigan reporting 681 cases since June 22. The parasitic infection, caused by Cyclospora cayetanensis, is challenging to trace due to its genetic variability. Investigations are ongoing to identify the outbreak source.
- Recall issued for frozen blueberries due to possible e. Coli contamination
The U.S. Food and Drug Administration has recalled frozen GreenWise Organic Blueberries due to possible E. coli contamination. The product was sold at Publix stores in eight states, and consumers are advised not to consume it due to 12 confirmed cases of illness linked to the contamination.
- Recall alert: Blueberries shipped to Publix stores recalled over E. coli concerns
Frozen GreenWise Organic IQF Blueberries sold in eight Southern U.S. states are being recalled due to potential E. coli O145 contamination. The recall, initiated by Frutas y Hortalizas del Sur S.A. and Publix, follows 12 confirmed cases of illness linked to the product.
- Abortion medication, HPV vaccine laws take effect Wednesday in three states
New laws in Iowa, Mississippi, and Tennessee restrict access to abortion medications and limit minors' access to sexual and reproductive healthcare, including the HPV vaccine. A federal lawsuit challenges FDA rules allowing mifepristone to be dispensed via telehealth, with nationwide implications.
- Recall of potato chips upgraded to FDA's highest level due to salmonella risk
The FDA upgraded a recall of 'Zapps' and 'Dirty' potato chips to its highest level (Class I) due to a salmonella risk linked to a seasoning containing dry milk powder. Utz Quality Foods issued a voluntary recall in May, urging consumers to discard affected products and contact the company for refunds.
- That cup of coffee you had this morning may lower your risk for liver disease
A large study found that coffee consumption, including decaffeinated, may reduce risks of liver disease, cirrhosis, and liver cancer. The study tracked over 354,000 participants for more than a decade, showing higher coffee intake correlated with lower risks, though associations were not proven to be causal.
- Potato chip recall upgraded to FDA's highest risk level over salmonella concerns
The FDA upgraded a recall of over 650,000 bags of Zapp's and Dirty potato chips to its highest risk level due to potential salmonella contamination. The Class I recall includes multiple flavors and sizes with specific best-by dates, and Utz Quality Foods initiated the recall in May after identifying a risk in a seasoning ingredient. No illnesses have been reported.
- Abortion medication, HPV vaccine laws take effect Wednesday in three states
New laws in Iowa, Mississippi, and Tennessee restrict access to abortion medications and HPV vaccines for minors, effective July 1. The laws require in-person dispensing of abortion pills and prohibit minors under 18 from consenting to STD-related vaccinations in Iowa. A federal lawsuit challenges FDA rules allowing telehealth dispensing of mifepristone, which could impact nationwide access.
- Abortion medication, HPV vaccine laws take effect today in three states
New laws in Iowa, Mississippi, and Tennessee restrict access to abortion medications like mifepristone and misoprostol and limit minors' access to the HPV vaccine. A federal lawsuit challenges FDA rules allowing telehealth dispensing of mifepristone, with nationwide implications.
- Peptides are everywhere in health and beauty, but does the science actually back up the claims?
Peptides are widely promoted in health and beauty for benefits like weight loss and tissue repair, but many sold as 'research only' lack FDA approval. The FDA is easing access to peptides despite warnings about undermining drug approval, while experts note that only rigorously studied, FDA-approved peptides (like Tirzepatide and Semaglutide) have strong scientific backing.
- Opinion: STAT+: The U.S.-China biotech crackdown may hurt the scientists America needs the most
The article discusses concerns that the U.S.-China biotech crackdown could harm American scientists, as China's biotech sector grows, contributing 34% of global new drugs in clinical development and out-licensing deals reaching $137.7 billion by 2025. It highlights tensions over intellectual property fears and state-run companies in China.
- Nearly 1 million bottles of heart and kidney medication recalled over foreign substance found on tablets
Nearly one million bottles of heart and kidney medication have been recalled nationwide due to the possibility of a 'foreign substance' found on tablets, as reported by the US Food and Drug Administration.
- Nearly 1 million bottles of heart and kidney medication recalled over foreign substance
Nearly one million bottles of heart and kidney medication have been recalled nationwide due to the possibility of a foreign substance, as reported by the U.S. Food and Drug Administration.
- Nearly 1 million bottles of heart and kidney medication recalled over foreign substance
Nearly one million bottles of heart and kidney medication have been recalled nationwide due to the presence of a foreign substance, as reported by the U.S. Food and Drug Administration. The recall is over the possibility of a contaminating foreign substance in the medication.
- Judge temporarily blocks subpoenas in criminal probe of transgender care at New York hospitals
A federal judge temporarily blocked Texas prosecutors from accessing transgender patient medical records at New York hospitals, citing unconstitutional government overreach and violations of privacy. The ruling, in a lawsuit filed by minors and families receiving gender-affirming care, criticized the Justice Department's criminal probe into FDA drug misbranding as an improper effort to target transgender individuals.
- Judge temporarily blocks subpoenas in criminal probe of transgender care at New York hospitals
A federal judge in New York temporarily blocked Texas prosecutors from accessing medical records of transgender patients treated at New York hospitals, calling the government's efforts unconstitutional and part of an improper campaign to 'demonize and eradicate' transgender people. The ruling came in a lawsuit filed by minors, parents, and adults who received gender-affirming care, with the Justice Department seeking records as part of a drug 'misbranding' probe.
- STAT+: Want high-quality generic drugs? One expert has ideas on how consumers can trust their supply
Generic drugs, which make up 90% of U.S. prescriptions, face quality issues leading to shortages, with over 60% of shortages due to quality concerns. Kevin Schulman, a Stanford professor, proposes FDA-encouraged independent lab testing to improve trust, citing Valisure's findings of impurities in medicines.
- Raw milk sickens 11 people in Louisiana; health officials investigate
Eleven people in Louisiana have fallen ill after consuming raw milk, with two hospitalized, prompting an investigation by the Louisiana Department of Health. The illnesses are linked to bacterial infections from three raw milk operations, though selling raw milk for human consumption is illegal in the state.
- STAT+: Pharmalittle: We’re reading about FDA reforming clinical trials, a Pfizer setback, and much more news
Pfizer disclosed that its experimental lung cancer drug, sigvotatug vedotin, failed to show a statistically significant improvement over docetaxel in a clinical trial. The U.S. Food and Drug Administration announced a pilot program to accelerate early-stage clinical trials, aiming to reduce development timelines and counter Chinese dominance in the field.
- FDA recalls more than 11,000 bottles of blood pressure drug
The FDA has recalled 11,460 bottles of chlorthalidone tablets, USP, 25 milligrams, due to failure to meet dissolution standards during testing, which may reduce the medication's effectiveness. The recall includes 100-count bottles with batch number RISA24001 and 1,000-count bottles with batch number RISB24002, all expiring in April 2027.
- STAT+: Pharmalittle: We’re reading about another FDA reversal, pharma’s M&A spree and much more
The FDA will reconsider approving a gene therapy for a rare childhood brain disorder it previously rejected, following recent leadership changes. The U.S. also launched a trade investigation into Germany's plan to reduce pharmaceutical spending, which faced industry opposition and was revised.
- A better sunscreen has been available in Europe for 25 years. It just became legal to sell in the U.S.
The U.S. FDA approved bemotrizinol, a sunscreen ingredient used in Europe and Asia for decades, as the first new over-the-counter sunscreen ingredient in the U.S. since 1999. The approval, effective June 9, 2026, highlights a long-awaited addition to U.S. sun protection options.
- Texas lawmakers talk screwworm fight during stakeholder meeting
Texas lawmakers and federal officials met to discuss strategies for combating the spread of New World screwworms in South Texas, where 11 cases have been confirmed. Discussions included using ivermectin in livestock feed and releasing sterilized male flies, though the FDA cautioned against unapproved feed additives. No wildlife cases have been detected yet.
- U.S. FDA, HHS, GSA break ground on $228M food lab at the Denver Federal Center
The U.S. FDA, HHS, and GSA broke ground on a $228 million food lab at the Denver Federal Center to enhance research capabilities for managing foodborne illness outbreaks and ensuring safety. The facility will be the FDA's only Biosafety Level 3 lab west of the Mississippi River, replacing outdated infrastructure and expected to open by 2029.
- U.S. FDA, HHS, GSA break ground on $228M food lab at the Denver Federal Center
The U.S. FDA, HHS, and GSA broke ground on a $228 million food lab at the Denver Federal Center to enhance food safety research and replace outdated facilities. The lab will be the FDA's only Biosafety Level 3 facility west of the Mississippi River, aiming to improve responses to foodborne illness outbreaks and ensure product safety.
- STAT+: Pharmalittle: We’re reading about hackers extorting Novo, an FDA about-face, and more
A cyber extortion group claimed to have stolen over a terabyte of data from Novo Nordisk, including proprietary information and AI model data, and demanded $25 million. The U.S. Food and Drug Administration reversed its opposition to an experimental Huntington’s disease treatment, allowing UniQure to pursue marketing approval.
- One US-made drug treats congenital syphilis, and the country is running short
The U.S. faces a shortage of Bicillin L-A, the only first-line injectable penicillin for treating syphilis in pregnant women to prevent congenital syphilis, following a Pfizer recall due to contamination. The FDA estimates normal supplies won’t return until December 2027, forcing temporary reliance on imported Lentocilin from Portugal. The shortage risks worsening disparities in congenital syphilis rates, particularly affecting Indigenous and Black infants.
- One US-made drug treats congenital syphilis, and the country is running short
The U.S. is facing a shortage of Bicillin L-A, the only U.S.-made antibiotic for treating syphilis in pregnant women to prevent congenital syphilis. Pfizer's recall of the drug due to contamination risks has delayed supply until 2027, forcing temporary reliance on imported Lentocilin. The shortage risks worsening infection rates, particularly among Indigenous and Black infants.
- One US-made drug treats congenital syphilis, and the country is running short
The U.S. faces a shortage of Bicillin L-A, the only first-line injectable penicillin for treating syphilis in pregnant women to prevent congenital syphilis. Pfizer's recall of the drug due to contamination risks, combined with limited manufacturing capacity, has delayed supply until 2027, raising concerns about rising infection rates and disparities affecting Indigenous and Black infants.
- One US-made drug treats congenital syphilis, and the country is running short
The U.S. faces a shortage of Bicillin L-A, the only first-line injectable penicillin for treating syphilis in pregnant women to prevent congenital syphilis. Pfizer's recall of the drug due to contamination risks has delayed supply until December 2027, forcing temporary reliance on imported Lentocilin. Health experts warn the shortage could worsen infection rates and disparities, as congenital syphilis causes severe, irreversible harm to infants.
- Nara Organics recalls baby formula after infant botulism outbreak
Nara Organics recalled its organic baby formula after three infants in California, Pennsylvania, and Washington developed botulism. The FDA and CDC advised parents to stop using the product and monitor for symptoms, with the affected formula manufactured in Europe and sold exclusively in the U.S.
- Recall alert: Nara Organics recalls infant formula over botulism concerns
Nara Organics, a New York City-based company, voluntarily recalled its powdered infant formula due to concerns over infant botulism linked to three cases across California, Pennsylvania, and Washington. The recall includes all lots distributed through Target stores, Target.com, and Nara.com between July 2025 and June 2026, with refunds offered to affected customers.
- One US-made drug treats congenital syphilis, and the country is running short
The U.S. faces a shortage of Bicillin L-A, the only first-line injectable penicillin for treating syphilis in pregnant women to prevent congenital syphilis, due to a Pfizer recall linked to contamination. The FDA projects normal supply won’t return until December 2027, exacerbating rising congenital syphilis rates and disparities among Indigenous and Black infants.
- Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak
Nara Organics recalled its organic baby formula sold at Target and online after a multistate infant botulism outbreak affected three babies in California, Pennsylvania, and Washington. The U.S. FDA and CDC advised parents to stop using the formula and monitor infants for symptoms, with no nationwide shortage expected.
- Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak
Nara Organics recalled its organic baby formula after a multistate infant botulism outbreak linked to the product. Three infants aged 2-5 months in California, Pennsylvania, and Washington were hospitalized and treated with FDA-approved BabyBIG after consuming the formula, which is sold in Target stores and online.
- Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak
Nara Organics recalled its organic baby formula sold at Target and online after a multistate infant botulism outbreak linked to the product. Three infants aged 2-5 months in California, Pennsylvania, and Washington were hospitalized, and the FDA confirmed the formula is associated with the illness. The CDC advises parents to stop using the product immediately.
- Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak
Nara Organics recalled its organic baby formula after a multistate infant botulism outbreak linked to its Whole Milk Organic Powdered formula. Three infants aged 2-5 months in California, Pennsylvania, and Washington fell ill, requiring hospitalization and treatment with BabyBIG, the FDA-approved therapy for infant botulism. The FDA and CDC advised parents to stop using the product immediately and monitor infants for symptoms.
- Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak
Nara Organics recalled its organic baby formula sold at Target and online after three infants across multiple states developed botulism. The FDA and CDC advised parents to stop using the product immediately and monitor infants for symptoms, with no shortage concerns reported.