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FDA has declared the shortage has ended and should outlaw compounded versions, they insist

By Truman Lewis Consumer News: Time to crack down on compounded GLP-1 drugs, health groups say of ConsumerAffairs
March 21, 2025

A coalition of over 20 leading health organizations is calling on the U.S. Food & Drug Administration (FDA) to enforce federal regulations on compounded weight-loss and diabetes medications now that the nationwide shortage of GLP-1 drugs has officially ended.

In a joint letter sent today, theObesity Action Coalition (OAC)andThe Obesity Society (TOS) along with major organizations including theAlliance for Womens Health & Prevention, theAssociation of Black Cardiologists, and theNational Hispanic Medical Association urged the FDA to stop compounding pharmacies and outsourcing facilities from continuing to produce unapproved versions of GLP-1 medications such astirzepatide (Zepbound)andsemaglutide (Wegovy/Ozempic).

GLP-1 medications have made a transformative impact in the obesity care space, saidJoseph Nadglowski, President and CEO of the OAC. As these medicines continue to grow in popularity, regulatory action and enforcement is critically needed to ensure patients have access to safe, FDA-approved treatments.

The letter follows recent announcements from the FDA confirming thatEli Lillys tirzepatideandNovo Nordisks semaglutideare no longer in shortage. As a result, compounders must now cease production of these medications under federal law which only allows compounding in limited circumstances, such as during drug shortages or when a specific patient need cannot be met by an FDA-approved drug.

Deadlines set

The FDA has set firm deadlines for winding down compounding operations:

  • March 19: Outsourcing facilities must stop making versions of tirzepatide.
  • April 22: Pharmacies must stop compounding semaglutide.
  • May 22: Larger outsourcing facilities must stop semaglutide compounding, or earlier if a federal court ruling is issued.

Now that the GLP-1 shortage is resolved, FDA faces a critical juncture in upholding its commitment to patient safety, saidAnthony Comuzzie, PhD, FTOS, CEO of TOS. Our message is simple FDA, the time is now to take decisive action.

While acknowledging that compounding has a role under limited conditions, the signatories warn that ongoing mass production of these medications outside FDA oversight posesserious safety risksto patients. They called on the FDA to:

  • Enforce existing regulationsand end unauthorized compounding.
  • Monitor complianceduring and after the transition period.
  • Educate providers and patientsabout the importance of using FDA-approved drugs.
  • Combat misinformationfrom companies promoting unregulated compounded drugs.

The letter was co-signed by a wide range of organizations representing patients, healthcare providers, minority health advocates, and chronic disease groups.

This action comes amid growing concern aboutunregulated compounding practices, which can lead to inconsistencies in dosage, contamination risks, and misleading marketing. The coalition emphasized that regulatory clarity is essential toprotect patientsand upholdtrust in the healthcare systemas GLP-1 medications become more widely used for chronic disease management.

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Posted: 2025-03-21 21:03:50

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More News From This Category
Consumer News: Nissan ends production of the Versa in the U.S.
Sun, 28 Dec 2025 05:07:07 +0000

It's another blow for automotive affordability

By James R. Hood of ConsumerAffairs
December 24, 2025

  • Nissan has ended U.S. production of the Versa, long the cheapest new car sold in America.

  • The subcompact sedan will not return for the 2026 model year, leaving a higher price floor for new vehicles.

  • Its exit underscores the steady disappearance of truly affordable new cars from the U.S. market.


Yet again, the cheapest new car in America is exiting stage left. The Nissan Versa will not see a 2026 model year, with production for the U.S. market officially ending this month.

In a brief statement, Nissan said the decision aligns with its broader product strategy. In line with Nissans product strategy, the Nissan Versa ended production in December 2025 for the U.S. market, the automaker said. Nissan remains committed to offering affordable and stylish vehicles in the sedan segment with models like Sentra and Altima, while also offering strong value in the compact SUV segment with the Kicks, Road & Track reported.

With the Versa gone, the 2026 Kia K4 sedan is currently positioned as the least expensive new car available, with a starting price around $23,385.

The cheapest new Nissan now costs more than $23,000

At the end of its run, the Versa started at $20,435 with an automatic transmission, the only version still in production after Nissan discontinued the manual earlier this year. With the Versa gone, the least expensive 2026 model-year Nissan will be the Sentra, which starts at $23,845. The subcompact Kicks crossover follows closely at $23,925.

No other new vehicle on sale today comes close to the Versas roughly $20,000 starting price. For the 2026 model year, the title of cheapest new car in America shifts to the Kia K4, which carries a base price of $23,385.

Affordable cars continue to disappear

Perhaps thanks to its bargain positioning, the Versa was selling relatively well earlier this year. Over time, it evolved into a good enough affordable sedan, offering a respectable amount of technology and a driving experience that was no longer the penalty box it once was especially compared with its late-2000s days, when it was famously marketed with a sub-$10,000 price tag.

What its departure highlights most sharply is the continued erosion of affordability in the new-car market. Each year, the cost of entry for a new vehicle with a factory warranty rises, and the loss of the Versa marks another step in the steady retreat of truly low-cost new cars in the United States.


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Consumer News: Forward Farms ground beef recalled, possible E. coli contamination
Sun, 28 Dec 2025 02:07:06 +0000

Distrubted mostly in western states and Pennsylvania

By News Desk of ConsumerAffairs
December 28, 2025

Mountain West Food Group, LLC, a Heyburn, Idaho establishment, is recalling approximately 2,855 pounds of raw ground beef products that may be contaminated withE. coliO26, the U.S. Department of Agricultures Food Safety and Inspection Service (FSIS) announced today.

The raw ground beef item was produced on Dec. 16, 2025. The following product is subject to recall [view labels]:

  • 16-oz. (1-lb.) vacuum-sealed packages containing FORWARD FARMS GRASS-FED GROUND BEEF with USE OF FREEZE BY 01/13/26 EST 2083 printed on the side of the packaging.

The product subject to recall bears establishment number EST 2083 printed on the side of the packaging. The product was shipped to distributors in California, Colorado, Idaho, Montana, Pennsylvania, and Washington for further distribution for retail sales.

The problem was discovered during routine FSIS testing and the sampling results showed the presence ofE. coliO26.

There have been no confirmed reports of illness due to consumption of these products. Anyone concerned about an illness should contact a healthcare provider.

E. coliO26, like the more commonE. coliO157:H7, is a serovar of Shiga toxin-producingE. coli(STEC). People can become ill from STECs 28 days (average of 34 days) after exposure to the organism.

Most people infected with STEC O26 develop diarrhea (often bloody) and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended. Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS), a type of kidney failure, is uncommon with STEC O26 infection. HUS can occur in people of any age but is most common in children under 5 years old, older adults and persons with weakened immune systems. It is marked by easy bruising, pallor and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

FSIS is concerned that some product may be in consumers refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify theircustomers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website atwww.fsis.usda.gov/recalls.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of 160 degrees F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature,https://www.fsis.usda.gov/safetempchart.


Read More ...


Consumer News: Nissan ends production of the Versa in the U.S.
Wed, 24 Dec 2025 23:07:04 +0000

It's another blow for automotive affordability

By James R. Hood of ConsumerAffairs
December 24, 2025

  • Nissan has ended U.S. production of the Versa, long the cheapest new car sold in America.

  • The subcompact sedan will not return for the 2026 model year, leaving a higher price floor for new vehicles.

  • Its exit underscores the steady disappearance of truly affordable new cars from the U.S. market.


Yet again, the cheapest new car in America is exiting stage left. The Nissan Versa will not see a 2026 model year, with production for the U.S. market officially ending this month.

In a brief statement, Nissan said the decision aligns with its broader product strategy. In line with Nissans product strategy, the Nissan Versa ended production in December 2025 for the U.S. market, the automaker said. Nissan remains committed to offering affordable and stylish vehicles in the sedan segment with models like Sentra and Altima, while also offering strong value in the compact SUV segment with the Kicks, Road & Track reported.

The cheapest new Nissan now costs more than $23,000

At the end of its run, the Versa started at $20,435 with an automatic transmission, the only version still in production after Nissan discontinued the manual earlier this year. With the Versa gone, the least expensive 2026 model-year Nissan will be the Sentra, which starts at $23,845. The subcompact Kicks crossover follows closely at $23,925.

No other new vehicle on sale today comes close to the Versas roughly $20,000 starting price. For the 2026 model year, the title of cheapest new car in America shifts to the Kia K4, which carries a base price of $23,385.

Affordable cars continue to disappear

Perhaps thanks to its bargain positioning, the Versa was selling relatively well earlier this year. Over time, it evolved into a good enough affordable sedan, offering a respectable amount of technology and a driving experience that was no longer the penalty box it once was especially compared with its late-2000s days, when it was famously marketed with a sub-$10,000 price tag.

What its departure highlights most sharply is the continued erosion of affordability in the new-car market. Each year, the cost of entry for a new vehicle with a factory warranty rises, and the loss of the Versa marks another step in the steady retreat of truly low-cost new cars in the United States.


Read More ...


Consumer News: Tesla door handles face new U.S. safety probe
Wed, 24 Dec 2025 23:07:04 +0000

Tesla owners say they've been trapped in the cars and needed help to escape

By James R. Hood of ConsumerAffairs
December 24, 2025

  • U.S. auto safety regulators have opened a new probe into Teslas emergency door releases on certain Model 3 sedans.

  • The review follows a petition from a Georgia driver who says he was trapped in a burning vehicle because the manual release was hard to find.

  • The action broadens federal scrutiny of Teslas electric door handles after reports of injuries and deaths linked to doors that wouldnt open.


Tesla'sdoor handles are facing renewed scrutiny in the U.S. after federal auto safety regulators opened a probe into the emergency releases in certain Model 3 vehicles.

The National Highway Traffic Safety Administration said it is evaluating claims that the mechanical door release is hidden, unlabeled, and not intuitive to locate during an emergency, according to a filing on the agencys website. The review stems from a petition filed by Kevin Clouse, a Tesla owner in Georgia, who says he was trapped in his vehicle in 2023 and requested a formal defect investigation. NHTSA said it has not yet decided whether to grant or deny the petition, Bloomberg reported.

The probe covers an estimated 179,071 Model 3 sedans from the 2022 model year.

Investigation expands after prior federal scrutiny

The latest move expands on a broader federal examination of Tesla door problems following a months-long investigation by Bloomberg, which documented incidents in which people were severely injured or died after becoming trapped inside Teslas.

In September, NHTSA opened a separate investigation into whether doors are defective in certain Model Y SUVs after reports of children being stuck inside vehicles when the 12-volt battery failed. The Model 3 and Model Y are Teslas top-selling vehicles.

Tesla was an early adopter of electrically powered door handles, which can stop functioning without warning particularly after a crash. A Bloomberg analysis published this week identified at least 15 deaths in a dozen incidents over the past decade in which occupants or rescuers were unable to open the doors of Teslas that had crashed and caught fire.

Bloomberg has also reported that potential safety concerns about electric door handles were raised with Chief Executive Officer Elon Musk during development of the Model 3, but that Musk pushed ahead with the futuristic design, relying on manual releases to address power-loss scenarios.

Owner describes escape from burning vehicle

Clouse filed his petition last month, citing a 2023 incident in which he says he had to kick his way out of his burning Model 3 when the doors would not open. Bloomberg previously reported details of his case.

I was unaware of the location of the hidden mechanical emergency door release because it is not visibly labeled, not explained upon delivery, and not intuitive in an emergency, Clouse wrote in a complaint filed with NHTSA. I was forced to climb to the back seat and break the rear passenger window with my legs to escape while the interior was burning.


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Consumer News: Latest food recalls, 12/24/2025
Wed, 24 Dec 2025 20:07:06 +0000

Shrimp, oysters, kielbasa among today's active recalls

By News Desk of ConsumerAffairs
December 24, 2025

Here aretodays top U.S. food recall/outbreak alerts. Some have been published earlier and are still in effect.


Frozen Raw Shrimp (Market32 & Waterfront Bistro) Possible Radioactive (Cesium137) Contamination

  • Product:~83,800 bags of frozen raw shrimp sold underMarket32andWaterfront Bistrobrands.

  • Hazard:Potentialcesium137 radioactive contaminationthat may raise longterm cancer risk.

  • Affected States/Retailers:Sold across ~17 states including NY, CT, IL, CO, NV at retailers like Price Chopper, JewelOsco, Safeway, Albertsons.

  • Illnesses/Injuries:No illnesseslinked to the recall; avoid consumption.

  • Full notice:FDA recall listing https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts(U.S. Food and Drug Administration)


Salmonella Outbreak Linked to Raw Oysters 64 Sick Across ~2122 States

  • Product:Raw oysters suspected in a multistateSalmonellaoutbreak (raw seafood consumption).

  • Hazard:Salmonella bacteria causing gastrointestinal illness.

  • Affected States/Retailers:At least 64 cases reported in~2122 statesincluding NY, PA, CA, TX, FL; source tracing ongoing.

  • Illnesses/Injuries:64 illnesseswith~20 hospitalizationsreported; outbreak under CDC investigation.

  • Full notice:CDC outbreak overview https://www.cdc.gov/foodborne-outbreaks/outbreaks/index.html(CDC)


Olympia Provisions Uncured Holiday Kielbasa Metal Foreign Material

  • Product:Olympia Provisions Uncured Holiday Kielbasareadytoeat sausage (~1,930lbs).

  • Hazard:Foreignmetal fragmentscontamination.

  • Affected States/Retailers:Distributed inCA, OR, WAandonline nationwide.

  • Illnesses/Injuries:No confirmed injuriesreported; product should not be consumed.

  • Full notice:USDAFSIS recall & alerts https://www.fsis.usda.gov/food-safety/alerts(FSIS)


Celebration Herbals Senna Leaf Herbal Tea Salmonella Contamination

  • Product:Celebration Herbals Senna Leaf Herbal Tea(24bag packages; UPC 628240201829, Lot 251004, BestBy 10/29/2028).

  • Hazard:PotentialSalmonellacontamination.

  • Affected States/Retailers:Distributed inFL, IN, MA, MI, MS, NY, WI & Puerto Rico.

  • Illnesses/Injuries:No illnesses reportedto date, but Salmonella can cause fever, diarrhea, cramps.

  • Full notice:FDA recalls database https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts(thehealthy.com)


Cheddar Cheese (Charlevoix) Possible Listeria Contamination

  • Product:Lot ofcheddar cheesefrom Charlevoix Cheese Company (Boss Dairy Farms).

  • Hazard:PotentialListeria monocytogenescontamination.

  • Affected States/Retailers:Sold inMichiganretail outlets.

  • Illnesses/Injuries:No illnesses reported; Listeria infection risk is serious for vulnerable groups.

  • Full notice:FDA recall listing https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts(Health)


Monitoring sources:
FDA Recalls https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts(U.S. Food and Drug Administration)
USDAFSIS Recalls & Alerts https://www.fsis.usda.gov/food-safety/alerts(FSIS)
CDC Outbreaks https://www.cdc.gov/foodborne-outbreaks/outbreaks/index.html(CDC)


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