1. HBW Insight
  2. >>Wellness
  3. >>Policy & Regulation
  4. >>Recalls

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.

Attention Please_1014394012_1200.jpg

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.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.

Loper Bright Could Trip FDA On Self-Affirmed GRAS

 
• By Malcolm Spicer

Instead of arguing FDA’s not authorized to offer option under authority from 1958 Food Additives Amendments, potential litigation could contend the law requires agency to continue making self-GRAS without notification available.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.