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Latest Articles

Global Policy, Regulation & Law

FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands

OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.

ECHA Committees Get Started On PFAS Opinions, Armed With More Than 5,600 Comments

The agency’s committees for Risk Assessment and Socio-Economic Analysis will check comments and take relevant evidence-based information into consideration as they develop their opinions. Final opinions will be delivered to the European Commission “in the shortest possible timeframe,” ECHA says.

‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role

During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry. 

US FTC Says It’s On ‘Solid Ground’ To Bring Cases Following Notices Of Penalty Offense

The US Federal Trade Commission is "fully prepared" to bring forward cases after issuing hundreds of penalty offense notices in April regarding health claims substantiation, and it is likely to seek injunctive and monetary relief, said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, at the National Advertising Division’s annual conference in Philadelphia.

Digital Health & AI

US Health And Wellness Executive Decisions: Perrigo, Nestle, Flexpower Health, Herbalife, More

NBA star Antetokounmpo invests in Flexpower; Perrigo changes Americas helm; Bündchen models healthy lifestyle for Gaia; Vit-Best appoints growth chief; Olympian Jennings works with Protein Puck; and more.

UK Health Service Not Taking Full Advantage Of Digital Self-Care Apps – PAGB Audit

PAGB calls on NHS England to create a self-care section in its NHS App and reinstate its online Apps Library to promote responsible digital self-care in the UK. 

FTC On AI And Consumer Vulnerabilities: ‘One Self-Regulatory Failure Is Begetting Another’

The US FTC’s Sam Levine, director of the Bureau of Consumer Protection, discusses the advent of AI and the compounding risks consumers face in today’s evolving, largely unregulated, profoundly uncertain digital age.

Cosmetic And Personal Care Weekly Trademarks Review: 19 September

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

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Sustainability

ECHA Committees Get Started On PFAS Opinions, Armed With More Than 5,600 Comments

The agency’s committees for Risk Assessment and Socio-Economic Analysis will check comments and take relevant evidence-based information into consideration as they develop their opinions. Final opinions will be delivered to the European Commission “in the shortest possible timeframe,” ECHA says.

Offset-Based Green Claims Like 'Carbon Neutral' Will Soon Be Banned In Europe

The Green Claims Directive has moved one step closer to becoming European Union law. Once passed, within 24 months CO2 offset-based claims like "carbon neutral" will be banned altogether, claims like “environmentally friendly” will require substantive backing and sustainability labels in general will need to be approved beforehand by certification schemes or public authorities. 

Colgate’s Recyclable Claims On Toothpastes Not Aligned With FTC Green Guides – Truth In Advertising

Colgate-Palmolive Co. misleadingly claims its Colgate and Tom’s of Maine toothpaste tubes are recyclable when most end up in landfills, according to Truth in Advertising, Inc. The group is calling for greenwashing investigations by the US Federal Trade Commission and California and Connecticut attorneys general.

Over The Counter 11 Sept 2023: Trends Shaping The OTC Industry Today, With BSS Consulting’s Birgit Schuhbauer

In the second part of HBW Insight’s exclusive interview with OTC industry veteran Birgit Schuhbauer, we discuss the trends that will shape the future of consumer health. Drawing on her extensive experience in OTC, most recently as global vice president of J&J’s Self Care franchise and president of the AESGP, Schuhbauer gives her views on consumer shifts towards self-care and prevention, digitalization and e-commerce, supply chain resilience and sustainability. Schuhbauer also offers an insiders perspective on moves by companies like Kenvue and Haleon to spin out as independent OTC players, and the implications for Rx-to-OTC switch.

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Interviews

Over The Counter 26 Sept 2023: Disrupting the Consumer Health Industry, With Maxwellia’s Anna Maxwell

In this episode, HBW Insight catches up with UK switch specialists Maxwellia to find out what’s next for the company that gave to the UK one of the first OTC daily contraceptive pills. Now a disruptive consumer health player in its own right, the company is looking for investors to take it to the next level and help launch two new women’s health products in the pipeline for next year, CEO Anna Maxwell reveals in this exclusive interview.

Get To Know: Rising UK Effervescent Wellness Star Phizz

London-based start-up Phizz markets in the UK's busy wellness category effervescent products that it claims effectively hydrate while also providing essential vitamins and minerals.

Cosmetics Europe Expanding To Meet Historic Challenges: ‘There’s Never Been A Time Like This’

Director-general John Chave discusses regulatory heavy-handedness in the EU, implications for animal testing, declining European investment, and Cosmetics Europe’s message to policymakers going into the 2024 EU elections and beyond.

‘Fully Caffeinated’ Or Not, EU’s Revision Of Cosmetic Products Regulation In Doubt Before 2024 Elections

The European Commission’s proposal for revising the EU’s regulation on cosmetic products is likely to release in the 2023 fourth quarter as a “caffeinated or slightly decaffeinated” distillation of the Chemicals Strategy for Sustainability, Cosmetics Europe director-general John Chave says. Prospects for the proposed regulation are questionable in light of EU elections slated for June 2024.

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Recent Stories

US Health And Wellness Executive Decisions: Perrigo, Nestle, Flexpower Health, Herbalife, More

NBA star Antetokounmpo invests in Flexpower; Perrigo changes Americas helm; Bündchen models healthy lifestyle for Gaia; Vit-Best appoints growth chief; Olympian Jennings works with Protein Puck; and more.

FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands

OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.

ECHA Committees Get Started On PFAS Opinions, Armed With More Than 5,600 Comments

The agency’s committees for Risk Assessment and Socio-Economic Analysis will check comments and take relevant evidence-based information into consideration as they develop their opinions. Final opinions will be delivered to the European Commission “in the shortest possible timeframe,” ECHA says.

‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role

During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry. 

US Cosmetics Executive News: L'Oréal Appoints SkinCeuticals USA Leaders; Estee Lauder Companies Taps Chief Procurement Officer

L'Oreal names Angela Hildebrand general manager and Amy Sloan senior VP of business strategy at SkinCeuticals USA. More executive leadership news.

US FTC Says It’s On ‘Solid Ground’ To Bring Cases Following Notices Of Penalty Offense

The US Federal Trade Commission is "fully prepared" to bring forward cases after issuing hundreds of penalty offense notices in April regarding health claims substantiation, and it is likely to seek injunctive and monetary relief, said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, at the National Advertising Division’s annual conference in Philadelphia.

Dutch Firm TheOTCLabs Enters UK Market With Kidsner Range

Amsterdam-based TheOTCLabs breaks into the UK consumer health market with Kidsner, a playfully marketed range of wellness products aimed at children aged 4 to 12 years old. 

UK Health Service Not Taking Full Advantage Of Digital Self-Care Apps – PAGB Audit

PAGB calls on NHS England to create a self-care section in its NHS App and reinstate its online Apps Library to promote responsible digital self-care in the UK. 

FTC On AI And Consumer Vulnerabilities: ‘One Self-Regulatory Failure Is Begetting Another’

The US FTC’s Sam Levine, director of the Bureau of Consumer Protection, discusses the advent of AI and the compounding risks consumers face in today’s evolving, largely unregulated, profoundly uncertain digital age.

No End To US FDA Concerns About DEG And EG Testing, Or To OTC Firms Not Answering Its Calls

One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.

Bausch + Lomb Spreads Into US Cosmetics Market, Extends Lumify Brand With Eye Illuminations Line

Canadian firm launches US sales of Lumify Eye Illuminations 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product contains hyaluronic acid, a fluid in eyes and joints which acts as a cushion and lubricant.

Over The Counter 26 Sept 2023: Disrupting the Consumer Health Industry, With Maxwellia’s Anna Maxwell

In this episode, HBW Insight catches up with UK switch specialists Maxwellia to find out what’s next for the company that gave to the UK one of the first OTC daily contraceptive pills. Now a disruptive consumer health player in its own right, the company is looking for investors to take it to the next level and help launch two new women’s health products in the pipeline for next year, CEO Anna Maxwell reveals in this exclusive interview.

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