Policy & Regulation


US FDA Meets OTC Monograph Program Overhaul Deadlines But Notes Facility Fees Behind Schedule

 

FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.

WA Regulators Open Rulemaking On Cosmetic Lead Limits; Provide Safe Harbor Under TFCA

 

The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’

Biovanta Wants US Consumers To Consider Cold Remedy Options, FDA To Reconsider Monograph

 

Biovanta’s products relieved symptoms faster than OTC drugs available under FDA monograph, according to clinical trial by brand owner Applied Biological Laboratories. Chief scientific officer Nazlie Latefi said the results were “greatest decreases to date in overall illness severity using clinically validated measures and comparable study design.”

Kenvue Survey Shows UK Pharmacists United Behind Self-Care Solutions

 
• By 

A recent Kenvue survey shows that an overwhelming majority of UK pharmacists believe many health issues could be prevented through better self-care.

Business


People On The Move: Appointments At Maxwellia, Reckitt, Barentz

 
• By 

A round-up of the latest European consumer health appointments: Maxwellia adds CFO and board member; Reckitt restructures operations; Barentz names CEO.

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

 
• By 

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.

Haleon Completes Deal To Grow Stake In China JV

 
• By 

Haleon now holds 88% of its China OTC joint venture after acquiring a larger stake in the business from its local partners.

Lumineux Mouthwash ‘Non-Toxic’ Claim Gets Adverse Reaction In Advertising Review

 

National Advertising Division found multiple faults with Oral Essentials’ evidence for claim, including that an in vitro study the firm conducted on “mouse cells is not dispositive of whether the same product would have any adverse effects on humans under real world conditions.”

Innovation & IP


Bayer Acquires Cara Care Digestive Health App To Grow Precision Health Business

 
• By 

Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.

Bayer Drops Plan For EU OTC Antifungal Launch After Poor Trial Results

 
• By 

Bayer Consumer Health shelves European launch of topical OTC onychomycosis treatment under its Canesten brand after a Phase III trial of the product - developed by Sweden's Moberg Pharma - failed to meet its primary endpoint.

Opella Crowned Company Of The Year At OTC Marketing Awards 2024

 
• By 

Winners across 12 categories were announced at the OTC Marketing Awards 2024 on 21 November, with Opella taking the top prize as OTC Company of the Year.

Denmark Switches Nalxone To OTC Status

 
• By 

Consumers in Denmark no longer need a prescription to buy opioid antagonist naloxone as the country looks to tackle the growing issue of overdose.

Rx-to-OTC Switch


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.