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In Brief: CHPA Disagrees With FDA Warning; Adulterated Supplements Enforcement; DASCA Support Sought

 
• By Elizabeth Crawford

FDA warns about painkillers for teething; enforcement against adulterated supplements; FDA warning letter for tainted bee pollen; Akorn must divest brands from Hi-Tech deal; senators seek support for DASCA; and consumer acetaminophen knowledge improves.

The Consumer Healthcare Products Association disagrees with a consumer update that FDA issued June 26 that suggests topical pain relievers and medications that are rubbed on the gums to relieve teething pain are not necessary or useful because they wash out of children’s mouths within minutes. The announcement does a “disservice to parents and caregivers who use FDA-approved OTC gel and liquid medicines containing benzocaine to treat their children’s suffering from teething pain,” the trade group said. The consumer alert directs caregivers not to use local anesthetics such as Rx viscous lidocaine or OTC benzocaine-containing products except under the advice and supervision of a health care provider.

The agency said in the alert that it ordered a black box warning added to Rx oral viscous lidocaine 2%...

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More from United States

Some Laid Off Employees Called Back At US FDA

 
• 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.

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 
• By Malcolm Spicer

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 
• By Malcolm Spicer

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

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.”

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.