Sales Of Drug-Spiked Supplements After Warnings Show Stronger US Regulation Needed – Study

"FDA should consider ways to ensure that prohibited drugs are removed from supplements, perhaps by testing products sold after warning letters and mandating recalls whenever products remain adulterated,” say Pieter Cohen and colleagues in JAMA study.

• Source: Shutterstock

Nine of 31 dietary supplements identified in US Food and Drug Administration warning letters as containing stimulant drugs remained available for sale an average of six years after the warnings, according to research led by a recognized critic of the agency’s regulation of the industry.

“This study raises questions regarding the FDA’s actions to ensure that manufacturers are compliant with the agency’s warning letters. The...

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

More from Compliance

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

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

 

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.

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

 

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

More from Policy & Regulation

US FDA’s Kratom Focus Pivots To ‘Concentrated Synthetic Byproduct That Is An Opioid’

 

Explaining he was a heroin addict for 14 years more than 40 years ago “because it was so available,” Secretary Kennedy says “our agencies have been asleep in the wheel” but “now we're going to wake up and we're going to start to stop this before it starts.”

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By 

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

US FDA Extracts More Evidence To Ban Kratom

 

Recent warning letters to seven companies marketing products with kratom extract known as 7-OH are FDA’s first in three years referencing unlawful products containing kratom and the first of all its kratom-related warnings to reference extracts from the botanical.