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Warnings On Kratom Opioid Withdrawal Claims Mark Tip Of FDA Concerns

 
• By Malcolm Spicer

Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.

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Kratom marketers shouldn't let down their guard about FDA's position on the herb.

The Office of Compliance in FDA's Center for Drug Evaluation and Research on Sept. 11 published warning letters submitted earlier in the month to an online retailer identified as "Chillin Max Kratom" and a North Carolina business, Mitra Distributing Inc

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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.