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FDA Gets Final With Guidance On Recall Public Warnings, Notifications

 
• By Bowman Cox

There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.

detailed illustration of a compass with Recall text, eps10 vector

When should firms issue public warnings and recall notifications about dietary supplements and other FDA-regulated products? And when can FDA step in and issue its own warnings?

The agency spells it all out in a Feb. 8 final guidance that among other things also:

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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

CHPA Survey Shows Consumer Trust In Supplements Strong, Not So Much In Regulation

 
• By Malcolm Spicer

Results of survey found a majority of representative sample of US voters nationwide agree “current regulations should be updated and strengthened to protect consumers,” CHPA says.

Clarity Requested For Kennedy’s MAHA ‘Chaos’

 
• By Malcolm Spicer

Discussion of the administration’s “Make America Healthy Again” campaign at a recent regulatory conference provided a platform for questions about what HHS Secretary Kennedy wants and how he expects to get there.

CHPA Navigates Trump Administration’s ‘Mixed Messages,’ Ready To Traverse DSHEA Changes

 
• By Malcolm Spicer

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”