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US FDA’s Proposed Sunscreen Order Due With Inquiry Ongoing Re Environmental Impacts

 
• By Ryan Nelson

Industry anticipates a proposed administrative order from the US FDA by 27 September on OTC sunscreen drug products, including GRASE status of active ingredients. Meanwhile, the agency’s probe continues into UV filter environmental impacts, and the National Academy of Sciences is gathering information to weigh those possible ills against human health consequences of reduced sunscreen use.

Coral reef (stockphoto-graf/Shutterstock.com)

UV filters are under intense scrutiny the world over, not only with respect to their human health effects but also their environmental impacts, creating a haze of uncertainty over the sunscreen products category.

In the US, the Food and Drug Administration is expected to issue a proposed order on sunscreens by 27 September, as required by the Coronavirus Aid, Relief and Economic Security (CARES)

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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.