1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Energy Drink Concerns Could Tilt Congress Toward DSHEA Changes

 
• By Malcolm Spicer

Supplement industry stakeholders see deaths reported in energy drinks AERs as a potential rallying point for Capitol Hill to consider tightening oversight of the industry. Senators Durbin and Blumenthal question FDA’s investigation of the deaths and ask for more action by the agency.

Deaths in adverse event reports for energy drink products could be a rallying cry for congressional interest in tighter FDA oversight of dietary supplements, trade group executives say.

Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., have pressed FDA on its investigation of the deaths reported in energy...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 United States

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
• By Sue Sutter

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.

More from North America

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.