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Despite FDA Request, Consumer Alert, Firm Won't Recall Spiked Supplement

 
• By Eileen Francis

FDA warns Wave Miami that its Lipro Dietary Capsule weight loss product contains tadalafil and the firm has not recalled it despite requests from the agency. FDA says the firm makes claims including helping users lose 30 pounds in 30 days.

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Wave Miami LLC could be testing the US Food and Drug Administration’s willingness to exercise its authority to order recalls of dietary supplements by not acting on the agency’s request to recall its product labeled as a supplement but containing an erectile dysfunction drug.

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More from Recalls

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

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Givaudan Has UTI Health Claim Turned Down In EU

 
• By Tom Gallen

European Food Safety Authority finds no cause and effect relationship between Givaudan's Pacran supplement and defense against urinary tract infections.

US Consumer Health Industry Buckles Up For Another Ride As Trump Swings Tariff Tool Again

 
• By Malcolm Spicer

Manufacturers, marketers and other businesses in the industry may be thinking, “Well, this is different” because the president ordered tariffs on a list of countries rather than on his sole first-term target of China.