In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers. 

Cataloging materials by category across US states or even internationally, chasing down information from supply partners, and other aspects of extended producer responsibility (EPR) program compliance can be a lot easier in collaboration with a software solutions vendor or other third party, says Michael Washburn, principal at Washburn Consulting.

Canadian firm received approval from FDA for NDA submitted in May 2023 for Lumify Preservative Free. A month earlier, FDA approved Dr. Reddy's ANDA submitted in July 2021 for an equivalent of Lumify’s formulation, brimonidine tartrate 0.025% ophthalmic solution.

Litigation the court agreed to accept for its term beginning in October doesn’t allege CBD in a tincture purchased in 2012 contained an unlawful level of delta-9 THC but contained any THC at all. Also, FDA Commissioner Califf encourages Congress to authorize regulatory pathway for lawful use of CBD and other hemp ingredients in supplements and food.

Walmart Inc. sent a brief to all its beauty and personal-care vendors detailing expectations for brands and other partners under the Modernization of Cosmetics Regulation Act, noting violations of the law breach its supplier agreements.

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

Litigation the court agreed to accept for its term beginning in October doesn’t allege CBD in a tincture purchased in 2012 contained an unlawful level of delta-9 THC but contained any THC at all. Also, FDA Commissioner Califf encourages Congress to authorize regulatory pathway for lawful use of CBD and other hemp ingredients in supplements and food.

Exclusion from procurement processes, confiscation of revenues, and a fine of at least 4% of annual turnover are some of the penalties the European Parliament is considering for greenwashing as part of its position on the EU Green Claims Directive. 

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.

White House’s 1,298-page budget request published on 11 March includes around $2m more than the agency’s total FY2024 spending Congress approved on 8 March and the president signed the next day. Of FDA’s total FY2025 spending $3.286bn would come from user fees.

“We think that this structure actually provides us the best path forward in terms of optimizing on our resources,” Jim Jones says of ODSP move. On the other hand, he says Congress didn’t appropriate for the agency’s optimal operation.

Beauty and personal-care companies should draft an artificial intelligence use policy as soon as possible, regardless of their AI plans, given its ubiquity and the potential for employees to use it on their own, says Melanie Howard, partner at Loeb & Loeb LLP.

The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.

Artificial intelligence opportunities are on the rise for marketers, including in the beauty and personal-care sectors. Reed Smith partner Stacy Marcus offers advice on staying compliant with US consumer protection and copyright laws in this rapidly changing world.

Benzoyl peroxide-based acne drug products and their alleged proclivity to become contaminated with carcinogenic benzene are at the center of putative class actions filing against L’Oreal in federal courts around the US.

Sephora successfully dismissed a putative class action in New York’s Northern District on 15 March, as the judge was not convinced by the plaintiff that a reasonable consumer would read “Clean at Sephora” as meaning “no synthetic or harmful ingredients whatsoever.”

J&J, Target and Walgreens face class action complaints in California federal courts for economic harms caused by their sale of benzoyl peroxide-containing acne treatments, following Valisure’s 5 March citizen petition to the US FDA on findings of high levels of benzene in such products.