Inside Regulatory Affairs
HBW Insight is shining a spotlight on the work of regulatory affairs specialists operating in and supporting the consumer health and cosmetics industries.
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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.
Congress will be on Capitol Hill briefly after 5 November elections before current session ends. It hasn’t prioritized re-authorizing 2018 farm bill, which de-scheduled hemp as a controlled substance. Until changes come through farm bill re-authorization or other legislation, federal definition of lawful hemp will remain any part of the cannabis plant containing no more than 0.3% concentration of delta-9 THC.
Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines.
At its most recent meeting, delegates to the Food and Agriculture Organization of the United Nations and World Health Organization’s Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discussed international harmonization guidelines for probiotics as constituents in foods and dietary supplements, based on a proposal to align international regulatory frameworks with guidelines established by the FAO/WHO.
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.
After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.
Perelel acquiring Loom online platform providing reproductive health, sexual wellness and parenting education. First direct-to-consumer product for Curive Healthcare’s Plum brand formulated for vaginal area dryness.
Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
Cosmetics Europe’s John Chave highlights the important role that industry must have in educating the public about chemicals used in cosmetic products. The association’s COSMILE Europe database launched last year is one such measure to combat misinformation while industry braces for potential impacts resulting from new hazard categories under the Classification, Labeling and Packaging (CLP) regulation.
Single-use packaging producers should heed the 1 October deadline in Colorado’s EPR law for paper and packaging to register with Circular Action Alliance lest they face enforcement action, said an advisor for that organization, which is leading the program’s administration, at IBA’s Cosmetics Convergence Fall 2024 Virtual Symposium.
In this episode of HBW Insight's Over The Counter podcast, we connect with Neil D’Souza, CEO of Makersite GmbH, a data software company based in Stuttgart, Germany that offers “next generation” product data management tools that help personal care and other industries manage product sustainability, cost and compliance.
The revised EU Urban Wastewater Treatment Directive, which obliges pharmaceutical and cosmetic industries to contribute at least 80% towards the costs of removing micropollutants from wastewater through quaternary treatments, will place an additional burden of around €2bn per year on German manufacturers, says Pharma Deutschland.
Cosmetics Europe’s John Chave highlights the important role that industry must have in educating the public about chemicals used in cosmetic products. The association’s COSMILE Europe database launched last year is one such measure to combat misinformation while industry braces for potential impacts resulting from new hazard categories under the Classification, Labeling and Packaging (CLP) regulation.
In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.
Cosmetics Europe hopes a more “competitive” spirit will define the 2024-2029 regime. Director-general John Chave discusses the association’s outlook on planned revisions to REACH and the Cosmetic Products Regulation in the new EU institutional mandate.
Genetic Analysis CEO Ronny Hermansen and Christina Casén, senior VP of clinical and medical affairs, discuss the company’s polymerase chain reaction (PCR)-based approach to gut microbiota profiling versus DNA sequencing, competitive landscape including DTC, and opportunities for supporting pharma R&D and assessing drug treatment success.
Congress will be on Capitol Hill briefly after 5 November elections before current session ends. It hasn’t prioritized re-authorizing 2018 farm bill, which de-scheduled hemp as a controlled substance. Until changes come through farm bill re-authorization or other legislation, federal definition of lawful hemp will remain any part of the cannabis plant containing no more than 0.3% concentration of delta-9 THC.
Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines.
A round-up of the latest appointments in Europe's consumer health industry: Dr Reddy's hires UK head; Mayoly names CEE lead; NèreS adds director.
At its most recent meeting, delegates to the Food and Agriculture Organization of the United Nations and World Health Organization’s Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) discussed international harmonization guidelines for probiotics as constituents in foods and dietary supplements, based on a proposal to align international regulatory frameworks with guidelines established by the FAO/WHO.
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.
CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador
Bayer adds dry eye treatment to its Bepanthen skin care range; Stada launches special edition Elotrans supplement for Eintracht Frankfurt fans; Hermes offers chewable magnesium supplement; and Klosterfrau introduces Oyono Night extension to help troubled sleepers maintain their immunity.
UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.
Italian personal care and beauty manufacturer Sodalis Group will acquire Alberto V05, Zest soap, Sure deodorants and other personal care brands in a transaction with current owner Tengram Capital Partners expected to close by the end of October. Recent years have seen high private equity activity in cosmetics and personal care.
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