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Global Policy, Regulation & Law

FDA’s Linda Katz Takes MoCRA Questions At IBA Regulatory Workshop

The director of FDA’s Office of Cosmetics and Colors addressed questions on the responsible person required by the Modernization of Cosmetics Regulations Act, safety substantiation, adverse event reporting and more at the IBA virtual event.

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

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. 

Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

Digital Health & AI

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.

Cosmetic And Personal Care Weekly Trademarks Review: 12 September

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

‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition

Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance

Cosmetic And Personal Care Weekly Trademarks Review: 5 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

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.

EU Cosmetics, Pharma Industries Expected To Pick Up Tab For Micropollutants Under Proposed UWWTD Recast

Cosmetics Europe says the European Commission’s proposed recast of the Urban Wastewater Treatment Directive places responsibility for micro-pollutants in urban wastewater squarely on the cosmetics and pharmaceuticals industries, ignoring other sources. The proposal would require Member States to provide for extended producer responsibility (EPR) systems to fund upgrades to wastewater treatment plants and administrative costs.

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Interviews

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.

Flarin’s Philip Lindsell: UK ITV Backing Could Provide Springboard For International Expansion

Flarin Holdings recently secured £5m ($6.2m) investment from UK television company ITV's Media for Equity fund in return for a minority stake in the company, which markets analgesic brand Flarin in the UK. The investment could be a springboard for international expansion, including in the US, Flarin's managing director Philip Lindsell tells HBW Insight in an exclusive in-depth interview.

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Recent Stories

MacuHealth Asserts ‘Rigorous Process’ In Research Supporting Claims, But No Bill Of Health From NAD

“MacuHealth believes challenged claims are thoroughly supported by the multitude of peer reviewed, published scientific studies” but NAD review on Vision Elements challenge finds firm’s research doesn’t support its claims.

Nestlé Partner Valbiotis Hails Trial Results For Prediabetes Supplement

Valbiotis and Nestlé Health Science plan to launch in 2024 a dietary supplement targeted at sufferers of prediabetes and type-2 diabetes following positive results from a recent study which showed the product's efficacy on key markers of glucose metabolism.

FDA’s Linda Katz Takes MoCRA Questions At IBA Regulatory Workshop

The director of FDA’s Office of Cosmetics and Colors addressed questions on the responsible person required by the Modernization of Cosmetics Regulations Act, safety substantiation, adverse event reporting and more at the IBA virtual event.

Health And Wellness Weekly Trademarks Review: 19 September

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

FTC's Substantiation Expectations In Consumer Health Claim Guidance Aren’t ‘Out Of Nowhere'

“Choosing which claims to make,” an advertiser “affects the amount of substantiation required. A structure function claim, supports digestive health, may require a different level of substantiation than if you choose to make the claim prevents diarrhea,” says FTC attorney Christine DeLorme.

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.

Pierre Fabre Takes Stake In French Women's Health Start-Up

France's Pierre Fabre is enhancing its presence in the women's health market by taking a stake in dietary supplements and cosmetics firm MiYé.

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. 

Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

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.

Over A Quarter Of EU Consumers Increase Supplement Intake But Financial Pressures Take Toll

Research from Stada shows that while a quarter of European consumers increased their dietary supplement intake compared to last year, one in five have cut back spending on such products. These are among the findings of the Stada Health Report 2023 which asked 32,000 people more than 30 questions covering topics such as health prevention and satisfaction with national healthcare systems.

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.

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