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Latest Articles

Global Policy, Regulation & Law

EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging

The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.

Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims

“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.

Some Topical Analgesics Draw Outside US FDA’s Lines For Formulations And Indications

FDA warns six businesses found selling directly to consumers topical formulations containing lidocaine outside the 0.5% to 4% concentration range allowed under OTC monographs for topical analgesics

National Advertising Division Shuts Down Skincarebrandsreviews Website

NourishMax agreed to discontinue “top pick” claims for its Diamond Infused Eye Cream and fold up its website that looked suspiciously to NAD like advertising in the guise of independent, honest reviews.

Digital Health & AI

Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States

Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.

National Advertising Division Shuts Down Skincarebrandsreviews Website

NourishMax agreed to discontinue “top pick” claims for its Diamond Infused Eye Cream and fold up its website that looked suspiciously to NAD like advertising in the guise of independent, honest reviews.

Cosmetic And Personal Care Trademark Review: 19 March

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

Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.

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Sustainability

EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging

The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.

Haleon Smashes Toothpaste Tube Recycling Target

Haleon has rolled out 1.2bn recycle-ready tubes across the world, an achievement that the firm said is a “milestone” on its “journey towards realizing a circular economy for its product packaging.” Haleon is also introducing a more sustainable manufacturing process for several variants of its Sensodyne toothpaste brand, starting in the UK.

US Senate Considers State-Level EPR Recycling Programs While Mulling Federal Role

The US Senate Committee on Environment and Public Works discussed state extended producer responsibility programs with stakeholders including S.C. Johnson & Son at a 6 March hearing to consider what the “proper role” of the federal government should be to address the plastic waste crisis. Two recycling bills passed the Senate a week later that could help set the stage.

Hawaii Contemplates Measures To Increase Access To Sunscreens Following Sunscreen Bans

Hawaii looks to “ease the burden” of finding reef-safe sunscreens by distributing it to sunseekers at beaches. The proposed legislation comes roughly three years after the Aloha State began prohibiting sale of oxybenzone- or octinoxate-containing sunscreen products due to concerns about potential harm to coral.

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Interviews

Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States

Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.

Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen

In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.

ICCS President Hill On Growing Regulatory Confidence In Alternative Testing Methodologies

In the year since its establishment, the International Collaboration on Cosmetics Safety has worked to engage with regulators as they build frameworks for assessing cosmetic safety without animal tests. ICCS president and CEO Erin Hill discusses current challenges and what lies ahead.

When Using Artificial Intelligence In Pharma R&D, Start With Identifying Problem To Solve

VeriSIM uses generative AI for questions such as changing a drug molecule’s chemistry and machine learning to better predict potential biological implications. “When a child is learning a language, you're teaching a child starting from A-to-Z structures, and then suddenly they start speaking. Then they start learning different things, and then they get into problem solving. That's really what AI is getting really good at now,” says CEO Jo Varshney.

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Recent Stories

Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States

Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.

Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen

In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.

Timely Acquisition Keeps Germany's Dermapharm Growing

With its Branded Pharmaceuticals division negatively impacted by the end of the COVID-19 pandemic, the timely acquisition of supplements firm Arkopharma ensured Dermapharm recorded double-digit sales growth in 2023.

EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging

The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.

Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims

“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.

ICCS President Hill On Growing Regulatory Confidence In Alternative Testing Methodologies

In the year since its establishment, the International Collaboration on Cosmetics Safety has worked to engage with regulators as they build frameworks for assessing cosmetic safety without animal tests. ICCS president and CEO Erin Hill discusses current challenges and what lies ahead.

IFF Narrows Focus To Fragrance, Health, Food

International Flavors & Fragrances agrees to sell its Pharma Solutions business to plant-based ingredients company Roquette for an enterprise value of $2.85bn to reduce debt and streamline its business to three segments, including scents.

Some Topical Analgesics Draw Outside US FDA’s Lines For Formulations And Indications

FDA warns six businesses found selling directly to consumers topical formulations containing lidocaine outside the 0.5% to 4% concentration range allowed under OTC monographs for topical analgesics

Haleon Smashes Toothpaste Tube Recycling Target

Haleon has rolled out 1.2bn recycle-ready tubes across the world, an achievement that the firm said is a “milestone” on its “journey towards realizing a circular economy for its product packaging.” Haleon is also introducing a more sustainable manufacturing process for several variants of its Sensodyne toothpaste brand, starting in the UK.

US Consumer Health Market Has Plenty To Say During Women’s History Month

In addition to Opill sales starting, Kindra launches what it calls “the first-ever comprehensive vaginal health product system”; Los Angeles firm backed by Major League Baseball pitcher Justin Verlander and his wife, model Kate Upton, launches fighting bamboo pads and liners; FirmTech makes FemTech Lab 2024 lineup for help finding investors, raising capital and implementing business plan.

Norway's Orkla Prioritizes Seeing Off Private-Label Consumer Health Challenge

Alongside addressing the threat posed by private-label, Orkla Health CEO Isabelle Ducellier will over the coming three years focus on building global brands and simplifying the value chain to improve efficiency and extract synergies.

National Advertising Division Shuts Down Skincarebrandsreviews Website

NourishMax agreed to discontinue “top pick” claims for its Diamond Infused Eye Cream and fold up its website that looked suspiciously to NAD like advertising in the guise of independent, honest reviews.

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