Ruining The Mood, US FDA Says Glycerin, Oleate Cream Not Approved As OTC Contraceptive

Smart Women’s Choice promotes its namesake brand topicals with claims including “One hundred percent hormone-free, completely safe, natural birth control that cannot fail when used as directed and causes no harmful side effects,” FDA warning says.

Emergency contraceptives are available OTC in the US and numerous types and brands of daily oral contraceptives are approved for Rx distribution as are contraceptive devices. The Food and Drug Administration has informed a California business that its topical labeled as a vaginal cream isn’t one of them.

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Revenue Drain Among Challenges For ACNU OTC Marketers From Simultaneous Rx Availability

 

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.

Statin In Technology-Assisted OTC Study May Be First To Take ‘Fail-First’ Step For ‘ACNU’ Switch

 

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

US FDA Doesn’t Budge On ‘ACNU’ Switch Requirements Questioned By OTC Industry

 

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

‘New Paradigm’ For US OTC Switches Dawns After More Than 12 Years With ‘ACNU’ Final Rule

 

FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.

More from Health

Statin In Technology-Assisted OTC Study May Be First To Take ‘Fail-First’ Step For ‘ACNU’ Switch

 

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

‘We All Have To Start Somewhere’: How Retailers Are Shaping Perrigo’s Climate Ambitions

 
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Perrigo's retail customers are expecting real "net zero" progress from consumer health manufacturers, which is in turn driving the firm's sustainability ambitions and expectations from their own suppliers, Perrigo’s UK ethical compliance lead Isobel Gay tells HBW Insight in this exclusive interview.

US FDA Doesn’t Budge On ‘ACNU’ Switch Requirements Questioned By OTC Industry

 

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.