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Kratom Advocates Urge Industry Compliance, FDA And DEA Compassion

 
• By Malcolm Spicer

Now that FDA has completed its evaluations of two compounds in kratom – mitragynine and 7-hydroxymitragynine – that DEA has proposed to schedule as controlled substances, researchers who attest to the ingredient's safety and its value in helping opioid abusers through withdrawal or as a natural pain reliever or mood enhancer say time could be running short to convince federal officials against ending consumer access to kratom products due to fear that the ingredient is an opioid.

FDA should regulate kratom as a dietary ingredient rather than the health threat the agency claims it is, not only due to its history of safe use similar to other botanicals but also because like other supplement ingredients, some products labeled as kratom are adulterated and should be removed from the market, experts say.

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• By Sarah Karlin-Smith

Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.

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• By Eileen Francis

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More from North America

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 
• By Eileen Francis

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

 
• By Derrick Gingery

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 
• By Malcolm Spicer

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.