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Ranitidine’s US Future In Limbo As Tests Continue; ‘Glow-Boosting’ Mask Also Among Recent Recalls

 
• By Malcolm Spicer

Zantac marketer Sanofi says it’s unclear whether the product eventually will relaunch. In other recent consumer health and beauty recalls in US, a vitamin C-containing face mask is recalled following a “spike in complaints” about skin irritation and the insides of tubes of sodium chloride ophthalmic ointments made for Walgreens and CVS were found with materials used to make the containers.

Product Recall - Image

As recalls of ranitidine-containing drugs in the US due to nitrosamine contamination continue, the marketer of Zantac, the leading OTC antacid brand with the ingredient, says it’s not clear whether the product eventually will relaunch.

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Old Problem Of Drugs In Supplements Welcomes US FDA’s Acting Food Chief To New Program

 
• By Malcolm Spicer

Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 
• By Malcolm Spicer

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

US Formula Market Astir With Changes As Congress Stirs Tighter Product Quality Regulations

 
• By Malcolm Spicer

Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.

Different Name, Same Contamination, Recall Problems For US Homeopathic Nasal Spray Firm

 
• By Malcolm Spicer

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

More from Policy & Regulation

State Actions, Proposals On Food Additive Bans Reflect Interest In Aligning With RFK Jr.’s View

 
• By Malcolm Spicer

Changes established in West Virginia and proposed in numerous other states gained momentum after Trump was elected to his second term as president and nominated Kennedy to head HHS.

Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

 
• By Malcolm Spicer

Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.

Availability Of Counterfeit Supplements Ringing Up Impact On Brand Sales And Consumer Safety

 
• By Malcolm Spicer

Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.