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Study Protocol – 24 March 2020
An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day SwitcH to mybluTM e-Cigarettes in Adult Smokers NCT# 04019626 Study Protocol – 24 March 2020 An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day Switch to my blu™ e-Cigarettes in Adult Smokers Sponsor Project No.: NER 01/001 Project No.: CA22747 Final Protocol: 28JAN2019 Protocol Amendment 1: 23APR2019 Protocol Amendment 2: 17MAY2019 Protocol Amendment 3: 24MAR2020 GCP Statement This study is to be performed in full compliance with the protocol, Good Clinical Practices (GCP), and applicable regulatory requirements. All required study documentation will be archived as required by regulatory authorities. Confidentiality Statement This document is confidential. It contains proprietary information of Nerudia Ltd. Any viewing or disclosure of such information that is not authorized in writing by Nerudia Ltd. is strictly prohibited. Such information may be used solely for the purpose of reviewing or performing this study. Page 1 CA22747_PROTOCOL AMENDMENT 3_24MAR2020 my blu Safety/Tolerability Study Project No.: CA22747 Nerudia Ltd. PRINCIPAL INVESTIGATOR SIGNATURE PAGE An Open-Label, Parallel Study to Assess Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-Day Switch to my ™ blu e-Cigarettes in Adult Smokers Principal Investigator: Printed Name: Site Name: Address: Tel.: Fax: E-mail: __________________________________ _________ Signature Date Page 7 CA22747_PROTOCOL AMENDMENT 3_24MAR2020 my blu Safety/Tolerability Study Project No.: CA22747 Nerudia Ltd. SYNOPSIS Study Objectives Primary: 1. -
The Teen Vaping Crisis
The Teen Vaping Crisis Carolina, Cindy, and Jay Problem ● JUUL, the leading company in electronic cigarettes, has sold 16.2 million e-cigarettes in 2017 ● 38% of high school students in the U.S. have tried vaping ● 10% of high school students in the U.S. have smoked ● The legal age to buy vapes in the U.S. is 18 ● Electronic cigarettes are too easily accessible for teens, despite its deadly consequences Why is this a problem? ● The nicotine content of JUUL pods is 5% or 50 mg/ml ● One JUUL pod has the same amount of nicotine as 20 cigarettes ● Leads to cancer and harms all organs ● Teens are too easily becoming addicted to nicotine 7 in 10 teens Are exposed to e-cig advertising Past Legislation ● Little regulation in packaging and distribution in USA at a national level ○ In Erie county, NY Governor Andrew Cuomo attached vaping legislation to his budget ■ Would ban companies from displaying vaping devices where children are allowed ■ Will also raise age to 21 ● Boxes have the warning “This product contains nicotine. Nicotine is an addictive chemical” ● Warning letters to companies who made the packaging look like candy ● Banned the sale of e-cigs to children under 18 ● Countries have plain packaging on normal cigarettes; saw 10% reduction in use in one year Constituents ● Government is working on regulating e-cigs ● Not much done with packaging Non-users ● Public opinion (STAT Harvard poll with 1014 people): Vapers Nearly 100% of users and non users agree that Total packaging should have warnings Solution ● More transparent/simple packaging -
14 Ways to Get Food and Beverage Brands Into the College Market White Paper
14 Ways to Get Food and Beverage Brands Into the College Market White Paper Presented by: NAM Youth Marketing PO Box 1170 Conway, NH 03818 The Importance of the College Demographic College students keep strange hours and their busy lifestyle impacts their choice of food and beverage purchases. They want food that does not slow them down and adds value to their lives. Snacks that cater to their on-the-go lifestyle are hugely popular among the college crowd, making college students a key consumer segment for the snack industry: “In fact, the serious snacking habits of college students contributed heavily to the $18.5 billion worth of snack sales in US restaurants, vending machines, and mobile vendors that was expected last year.”1 This shows the important role college consumers have on the snack industry. College students have huge spending power when it comes to buying snack food and their food consumption habits are growing increasingly atypical. Shawn LaPean, executive director of Cal Dining at the University of California-Berkeley, explains that “Eating weird is the new normal. If students eat any square meals per day, it might be one. The rest is filled with snacks and food on the go.”2 This trend away from traditional meals and towards increased snacking shows the growing value college students place on convenience. Though college students consume a lot of snacks, competition among snack companies remain fierce. One way to gain an edge over the competition is through collegiate marketing. Consumers between the ages of 18 and 24 spend the highest percentage of their income on snacks and non- alcoholic beverages. -
Nicotine Flavoring Other Chemicals to Help with the Aerosolization Process
Professor Rounds WHITEY SEVEY, MD PGY-1 What is this? What is a Juul? E-cigarettes Juul Juul labs produces: Juul device (w/charger) Disposable Juul pods How do e-cigarettes work? Produce an aerosol by heating a liquid Liquid usually contains: Nicotine Flavoring Other chemicals to help with the aerosolization process What makes Juuling different? The Juul pods contain: 0.7mL “e-liquid” with 5% nicotine by weight What makes Juuling different? The Juul pods contain: 0.7mL “e-liquid” with 5% nicotine by weight It’s the Nicotine. Amount of Nicotine Type of Nicotine Typical e-cigarettes contain between 6-30mg nicotine per 1mL of e-liquid Most e- Freebase 1 juul pod contains 59mg cigarettes nicotine Nicotine Juul salts Freebase Nicotine Vs. Nicotine Salt 81.5% of current youth users state they use “BECAUSE IT COMES IN FLAVORS I LIKE” 63% of 15-24 year-old Juul users DO NOT KNOW that the product ALWAYS CONTAINS NICOTINE Why does it matter? Why does it matter? Why does it matter? Marketing Marketing Marketing Marketing Marketing Marketing Backlash Juul’s ads changed Now about current smokers Backlash Juul’s ads changed Now about current smokers Backlash Juul’s ads changed Now about current smokers New warnings In ads Backlash Juul’s ads changed Now about current smokers New warnings In ads On packaging But… Even with the changes to advertising SOCIAL MEDIA has helped fuel Juul’s popularity Company Instagram, Twitter, and Facebook accounts #Hashtags Risks Tobacco use if the leading cause of preventable disease and -
Consuming-Kids-Transcript.Pdf
1 MEDIA EDUCATION F O U N D A T I O N 60 Masonic St. Northampton, MA 01060 | TEL 800.897.0089 | [email protected] | www.mediaed.org Consuming Kids The Commercialization of Childhood Transcript INTRODUCTION The consumer embryo begins to develop during the first year of existence. Children begin their consumer journey in infancy. And they certainly deserve consideration as consumers at that time. – James U. McNeal | Pioneering Youth Marketer [TITLE SCREEN] Consuming Kids: The Commercialization of Childhood NARRATOR: Not since the end of World War II, at the height of the baby boom, have there been so many kids in our midst. There are now more than 52 million kids under 12 in all in the United States – the biggest burst in the U.S. youth population in half a century. And for American business, these kids have come to represent the ultimate prize: an unprecedented, powerful and elusive new demographic to be cut up and captured at all costs. There is no doubt that marketers have their sights on kids because of their increasing buying power – the amount of money they now spend on everything from clothes to music to electronics, totaling some 40 billion dollars every year. But perhaps the bigger reason for marketers’ interest in kids may be the amount of adult spending that American kids under 12 now directly influence – an astronomical 700 billion dollars a year, roughly the equivalent of the combined economies of the world’s 115 poorest countries. DAVID WALSH: One economic impact of children is the money that they themselves spend – the money that they get from their parents or grandparents, the money that they get as allowance; when they get older, the money that they earn themselves. -
Juul and Other High Nicotine E-Cigarettes Are Addicting a New Generation of Youth
JUUL AND OTHER HIGH NICOTINE E-CIGARETTES ARE ADDICTING A NEW GENERATION OF YOUTH Launched in 2015, JUUL quickly disrupted the e-cigarette marketplace, popularizing e-cigarette devices that are sleek, discreet and have sweet flavors and a powerful nicotine hit. Nicotine is highly addictive, can negatively impact the development of the adolescent brain, and can harm the cardiovascular system.1 Youth e-cigarette use in the United States has skyrocketed to what the U.S. Surgeon General and the FDA have called “epidemic” levels, with 3.6 million middle and high school students using e- cigarettes. 2 Former FDA Commissioner Scott Gottlieb has stated, “There’s no question the Juul product drove a lot of the youth use.”3 The Surgeon General has called for “aggressive steps to protect our children from these highly potent products that risk exposing a new generation of young people to nicotine.”4 Use of Nicotine Salts Makes it Easier for New Users to Try E-Cigarettes Just like the tobacco industry has used additives and design changes to make cigarettes more addictive and appealing to new users (particularly youth),5 JUUL pioneered a new e-liquid formulation that delivers nicotine more effectively and with less irritation than earlier e-cigarette models. According to the company, the nicotine in JUUL is made from “nicotine salts found in leaf tobacco, rather than free-base nicotine,” in order to “accommodate cigarette-like strength nicotine levels.”6 JUUL’s original patent stated that, “certain nicotine salt formulations provide satisfaction in an individual superior to that of free base nicotine, and more comparable to the satisfaction in an individual smoking a traditional cigarette. -
Pass the Salt. Why Nicotine Salts Make Vaping Products More Addictive. February 2020
Why nicotine salts make vaping products more addictive Pass the salt Nicotine salts are a chemical form of nicotine that is easier to inhale Chemically speaking, a salt is a substance that is produced by the reaction of an acid with a base. Nicotine, as extracted from tobacco or created synthetically, is a base (pH greater than 7). In this form, it is sometimes called freebase nicotine. Freebase nicotine is harsh to the taste and hard to inhale. Exposing freebase nicotine to an acid converts the nicotine to a salted form. The nicotine molecule picks up a hydrogen proton, making it similar to the protonated nicotine found in cigarettes. This form has lower pH and produces a smoother sensation when being inhaled. E-cigarette companies treat nicotine with an organic acid to produce nicotine salts. JUUL uses benzoic acid; Vype uses lactic Figure 1 courtesy of Dr. Arit Harvanko, UCSF acid. Other brands use levulinic acid, or a combination of organic acids. E-cigarettes that are not treated with organic acids to create nicotine salts would have a pH of about 7.5- 8.0. Like cigars, they would be harsh to the taste and hard to inhale. Canadian cigarettes, which are smoother to the taste than American-blend cigarettes, have a slightly lower pH in the range of 5 to 6.1 2 Tobacco companies studied nicotine salts but used other ways to control pH in cigarette smoke. The tobacco industry has long known that organic acids could be used to create nicotine salts and that this would reduce harshness and make cigarettes more inhalable, and their studies of these methods began in the 1950s and continued until the 1990s.3 Cigarette manufacturers, however, chose other methods to produce smooth-tasting cigarettes with low pH. -
Factors Influencing Youth Customers Buying Behavior of Branded Goods
Factors Influencing Youth Customers Buying Behavior of Branded Goods Rahul Aditya1 and Dr.Vinay Kumar Yadav2 MBA Student1 and Assistant Professor2 Centre for Management Studies, Madan Mohan Malaviya University of Technology, Gorakhpur, U.P. Abstract India is being the highest youth population economy in the world. As we know that Information or a potential customer database is essential to get stay in the market and to develop a competitive edge for the success of any business. This article aims to explore the factors influencing customers buying behaviour of branded goods in Indian market. It is conceptual paper based on secondary data with help of content analysis. The result reflect towards the factors which influences the youth customers buying behaviour in purchase decision making of branded good in India. There are some factors like celebrity endorsement and brand image which influences the Indian youth customer buying behaviour. The key findings of the research may help policy makers and managers in formulating and implementing strategies to encourage purchasing. Keywords-Customer, Consumer Buying Behaviour, Branded Goods and Youth Introduction In today's world, the customer’s demand and the power of the retailers are tremendously growing due to the competitive environment and changing business. It is vital to have a sustainable relationship with customers for the survival and success of producers. Customers purchase products based on their preferences needs and buying power. One of the most striking changes that are visible is the entrant of young consumers who have been taking a keen interest in luxury consumption. This segment of the population is termed as Generation behavior, perceptions and attitudes determine their purchase intentions. -
Effect of Free-Base and Protonated Nicotine on Nicotine Yield From
www.nature.com/scientificreports OPEN Efect of free‑base and protonated nicotine on nicotine yield from electronic cigarettes with varying power and liquid vehicle Soha Talih1,3, Rola Salman1,3, Rachel El‑Hage2,3, Nareg Karaoghlanian1,3, Ahmad El‑Hellani2,3, Najat Saliba2,3 & Alan Shihadeh1,3* Nicotine in electronic cigarette (ECIG) liquids can exist in a free‑base or protonated (or “salt”) form. Protonated nicotine is less aversive upon inhalation than free‑base nicotine, and many ECIG manufacturers have begun marketing protonated nicotine products, often with high nicotine concentrations. Regulations intended to control ECIG nicotine delivery limit nicotine concentration but do not consider nicotine form. In this study, we systematically examined the efect of nicotine form on nicotine yield for varying powers and liquid vehicles. A Kanger Subox Mini‑C tank ECIG (0.5 Ω) was used to generate aerosols at varying powers (5–45 W) from liquid solutions that contained either free‑base or protonated nicotine at 15 mg/g concentration, with a liquid vehicle consisting of either propylene glycol (PG) or vegetable glycerin (VG), resulting in four diferent solutions (free‑base/ PG, free‑base/VG, protonated/PG, and protonated/VG). Nicotine yield was quantifed using gas chromatography‑mass spectrometry. Nicotine yields were not infuenced by nicotine form under any condition investigated. At each power level, PG‑based liquids resulted in approximately double the nicotine yield of VG‑based liquids. Nicotine concentrations in the aerosols matched those of the parent liquids for both the PG and VG conditions. Increasing power led to greater nicotine yield across all conditions. -
Complete Annual Report
Philip Morris International 2016 Annual Report THIS CHANGES EVERYTHING 2016 Philip Morris Annual Report_LCC/ANC Review Copy February 22 - Layout 2 We’ve built the world’s most successful cigarette company with the world’s most popular and iconic brands. Now we’ve made a dramatic decision. We’ve started building PMI’s future on breakthrough smoke-free products that are a much better choice than cigarette smoking. We’re investing to make these products the Philip Morris icons of the future. In these changing times, we’ve set a new course for the company. We’re going to lead a full-scale effort to ensure that smoke- free products replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. Reduced-Risk Products - Our Product Platforms Heated Tobacco Products Products Without Tobacco Platform Platform 1 3 IQOS, using the consumables Platform 3 is based on HeatSticks or HEETS, acquired technology that features an electronic holder uses a chemical process to that heats tobacco rather Platform create a nicotine-containing than burning it, thereby 2 vapor. We are exploring two Platform creating a nicotine-containing routes for this platform: one 4 vapor with significantly fewer TEEPS uses a pressed with electronics and one harmful toxicants compared to carbon heat source that, once without. A city launch of the Products under this platform cigarette smoke. ignited, heats the tobacco product is planned in 2017. are e-vapor products – without burning it, to generate battery-powered devices a nicotine-containing vapor that produce an aerosol by with a reduction in harmful vaporizing a nicotine solution. -
Juul Factsheet 2
HEALTH PROMOTION & ADVOCACY CENTER Juuls, Vapes, and E-Cigs Everything You Need to Know More than 20% of high school seniors report vaping regularly or occasionally The Risks of Juuling Many of the of the long-term consequences of Juuls, e-cigarettes, People who vape and vapes are unknown. A study at Johns Hopkins found some e- are more than 4x more likely to start cigarettes contain potentially toxic levels of lead, chromium and smoking nickel- in addition to nicotine absorbed at inhalation. cigarettes! Nicotine is a neurotoxin which can permanently alter brain structure in users under the age of 26, and has consequential cardiovascular affects. 1 2 3 59 MG 92% 2.8 MILLION There are over 15,500 completely The concentration of of vaporizer products The number of adults unregulated flavor nicotine per mL in devices contain diacetyl, a 18-24 in the United States options for e- like Juul- far more than in flavoring linked to severe who vape cigarettes/vapes cigarettes respiratory infection Primack, A.B., et al. “Initation of traditional cigarette smoking after electronic cigarette use” American Journal of Medicine (2017) Stanford University, “Tobacco Prevention Toolkit,” (2018) Rule, A.M., et al. “Metal concentrations in e-cigarette liquid and aerosol 1 samples” Environmental Health Perspectives (2018) HEALTH PROMOTION & ADVOCACY CENTER Nicotine In The Body A stimulant, nicotine is an extremely addictive drug which alters the pleasure pathway of the brain. The human brain can develop such a strong dependence on the drug that a user may no longer control their desire or smoking behaviors- especially problematic with subtle and more easily concealed devices such as Juul. -
HASHTAGNATION Marketing to the Selfie Generation
HASHTAGNATION MARKETING TO THE SELFIE GENERATION table of contents A NEW BALANCE OF VALUES-BASED MARKETING FACTORING IN CLOSING POWER GIVES WAY TO NeW CONSUMERISM THOUGHTS UTILITY & ENGAGEMENT 6 12 36 44 4 MARKETING TO THE SELFIE GENERATION WHO ARE PROSUMERS? Prosumers are today’s leading influencers and market drivers — and have been a focus ABOUT THE STUDY of Havas Worldwide studies for more than a decade. Beyond their own economic impact, In early 2014, Havas Worldwide partnered with Market Probe International to survey Prosumers are important because they 10,574 people aged 16+ in 29 markets: Argentina, Australia, Austria, Brazil, Canada, influence the brand choices and consumption China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, behaviors of others. What Prosumers are Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, doing today, mainstream consumers are likely Spain, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, to be doing six to 18 months from now. and Vietnam. Our aim was to develop a deeper understanding of the relationship between young people and brands. The survey sample was made up of 20 percent Learn more at leading-edge Prosumers and 80 percent mainstream consumers. http://www.prosumer-report.com. 5 Adolescents and young adults have long been a focus of MARKETING TO marketers — and not just because of their current purchasing power, but because these formative years are known to have a lasting influence on brand preference. Research from RoperASW THE SELFIE GENERATION shows that around age 11, children begin to break away from their parents’ brand choices and experiment with competitor brands.