IIVS, Non Animal Testing, Alternative Test Methods, In Vitro Toxicology | NewsType Publications
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Publications

Next-Generation Tobacco and Nicotine Products: Substantiating Harm Reduction and Supporting Tobacco Regulatory Science

June 21, 2018

A framework for the assessment of novel next-generation tobacco and nicotine products with the potential to reduce health risks compared with cigarettes should integrate scientific studies incorporating nonclinical, clinical, and population studies approaches.  These products should have lower emissions and exhibit reduced biological effects compared with those of cigarettes, ideally approaching those of smoking cessation.  The products should also be acceptable cigarette alternatives for current smokers, while not appealing to nonsmokers or former smokers.  Validating harm reduction and promoting regulatory acceptance of the assessment methods require a collaborative approach by industry, independent reviewers, the public health community, and regulatory agencies.  This article summarizes the science and approaches applied and considered to substantiate tobacco harm reduction in the light of regulatory requirements.  

Characterization of a Vitrocell VC1 Using Nicotine Dosimetry: An Essential Component Toward Standardized In Vitro Aerosol Exposure of Tobacco and Next Generation Nicotine Delivery Products

June 21, 2018

The U.S. Food and Drug Administration has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs).  There is a desire by the industry,  regulator and animal, protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment.  When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures (such as human reconstructed airways or lung slices) at the air–liquid interface are needed.  Using nicotine dosimetry, we report the characterization of a Vitrocell VC1 in our laboratories (IIVS, USA).  Nicotine, generated from a 3R4F reference cigarette or NGP (e-cigarette and THP) aerosols at source and the exposure interface (culture media), was assessed using ultra-high-performance liquid chromatography–tandem mass spectrometry.  These data were compared to published dosimetry data for the same products, generated at a different laboratory (BAT R&D, Southampton, UK), on different exposure systems (VC10 and Borgwaldt RM20S) to confirm repeatability.  

Know Your Skin Cells: III. The Melanocytes

February 1, 2018

IIVS toxicologist and study director, Emilia Costin wrote about melanocytes, responsible  for producing skin color for The Cosmetic Chemist. Read article

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

August 17, 2017

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures.  

Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology

July 19, 2017

By Dr. Gertrude-Emilia Costin Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in chemico or in vitro, of which some are validated for regulatory purposes. The manuscript also addresses emerging technologies in the form of “organ/body-on-a-chip” platforms which announce to be instrumental in allowing alternative systems to in vivo models to assess systemic toxic effects induced by chemicals.

Navigating the Claim Substantiation Maze in Cosmetics Industry

June 15, 2017

Read this article by IIVS study director Dr. Gertrude-Emilia Costin and biologist Asha Shravanthi Pidathala in the June 2017 issue of Eurocosmetics.  The article examines modern, relevant, and reliable in vitro testing strategies using pigmented tissue models that assess the capacity of ingredients and formulations that impact skin tone.