1. Pink Sheet
  2. >>Geography
  3. >>Latin America

FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door

 
• By Malcolm Spicer

USPlabs says it will reformulate its DMAA supplements, although it “stands by the safety and legality” of the products. FDA says “credible science” shows DMAA is not a botanical, not a dietary ingredient and will not be accepted in an NDI notification.

FDA appears to be successfully nudging all DMAA products on its radar off the market, and has deemed the product not a dietary ingredient, closing the door on a possible regulatory option for the bodybuilding ingredient.

USPlabs LLC on April 16 said it would cease using DMAA as an ingredient, but it continues to challenge FDA’s reasoning. “We disagree with FDA’s position,” the firm said

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 Latin America

More from Geography

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.