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

DMAA Is Synthetic And Needs NDI Notification – Study

 
• By Malcolm Spicer

Botanical experts refute that DMAA is a geranium plant derivative and that the ingredient has been common in the food supply, as some supplement manufacturers have argued. “Elementary mathematics establishes that [DMAA] in dietary supplements must be synthetic,” study authors say.

Research sponsored in part by the U.S. Anti-Doping Agency concludes that DMAA, an ingredient in strength-training dietary supplements and the subject of recent FDA warnings, is potentially an unsafe synthetic that is not derived from plant material, as some manufacturers long have claimed.

Researchers led by Mahmoud ElSohly, a professor in the National Center for Natural Products Research at the University of Mississippi,...

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

Cancer Drug Trials Must Be Ready To Pivot As Standards Of Care Shift

 
• By Sue Sutter

Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.

US FDA’s ‘Plausible Mechanism’ Pathway: A Platform-Based Approach Not Just For Rare Diseases

 
• By Sue Sutter

Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.

Second-Most Favored Nation? CMS Clarifies Medicaid Price Benchmark In GENEROUS Model

 
• By Cathy Kelly

Demonstration could bring unprecedented transparency into international net prices, at least to CMS.

Hope For Stability, Credibility As US FDA Vet Pazdur Takes Over CDER

 
• By Sarah Karlin-Smith

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.

More from North America

FY 2025 Generic Drugs By The Numbers

 
• By Derrick Gingery

New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.

Biohaven’s Troriluzole And The Era Of Real-Time Complete Response Letters

 
• By Michael McCaughan

US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.

Makary’s Expert Panel Sparks Regulatory Action For Menopause Hormonal Therapy

 
• By Sarah Karlin-Smith

The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.