Cancer Warning Labels on Alcohol Containers: A Consumer's Right to Know, a Government's Responsibility to Inform, and an Industry's Power to Thwart.

OBJECTIVE: Although the World Health Organization (WHO) declared alcohol a Class 1 carcinogen 30 years ago, few governments have communicated this fact to the public. We illustrate how alcohol industry groups seek to keep their customers in the dark about alcohol-related cancer risks. In Canada, a federally funded scientific study examining the introduction of cancer warning labels on containers was shut down following industry interference. We show that the industry complaints about the study had no legal merit. Of 47 WHO member countries with alcohol warning labels, only South Korea requires cancer warnings on alcohol containers. However, industry complaints, supported by sympathetic governments, helped weaken the warning labels' implementation. Ireland has legislated for cancer warnings but faces continuing legal opposition expressed through regional and global bodies. Cancer societies and the public health community have failed to counter industry pressures to minimize consumer awareness of alcohol's cancer risks. Placing cancer warnings on alcohol containers could make a pivotal difference in motivating both drinkers to consume less and regulators to introduce more effective policies to reduce the serious harms of alcohol consumption.

Gun Violence in Court.

Litigation cannot solve a public health crisis. But litigation can be an effective complementary tool to regulation by increasing the salience of a public health issue, eliciting closely guarded information to move public opinion, and prompting legislative action. From tobacco to opioids, litigants have successfully turned to courts for monetary relief, to initiate systemic change, and to hold industry accountableFor years, litigators have been trying to push firearm suits into their own litigation moment. But litigation against the gun industry poses special challenges. Not only has the regulatory regime failed to prevent a public safety hazard, Congress has consistently underfunded and understaffed the relevant regulatory actors. And in 2005 it legislatively immunized the gun industry from suit with the Protection of Lawful Commerce in Arms Act (PLCAA).This paper surveys the field of litigation in response to gun violence, tracking the limited successes of victims and stakeholders suing the gun industry. We find that victories remain confined to individual actors and unlike high-impact public litigations in other areas, aggregate class actions and major public litigation led by state attorneys general are noticeably absent in the firearm context.

REGULATORY-LEGISLATIVE AND ECOLOGICAL-HYGIENIC ISSUES ON THE LOCATION OF MODERN MOTOR VEHICLE FILLING STATIONS.

The article presents the results of the comprehensive hygienic studies of ambient air pollution (based on calculated and actual concentrations of main pollutants) in a zone of influence of modern filling stations (FS) of small and medium capacity, taking into account compliance with the fire-prevention requirements. Sanitary protection zones (SPZ) for filling stations were substantiated taking into account the capacity: for the filling stations of low and medium capacity - not less than 50 m, and for filling stations of large capacity - not less than 100 m at the equipping with the ecologically safe outfit, introduction of the effective air protection measures, and introduction of risk approach to sanitary-and-epidemiological assessment of the location of filling stations. Sanitary classification of the enterprises and industries was proved to require a revision and rationing of differentiated sanitary protection zones (minimum and maximum SPZ) for filling stations taking into account the capacity, implementation of the effective air protection measures and introduction of risk approach to sanitary- and-epidemiological assessment of the location of filling stations. A necessity of the introduction of the equipment to contain the carcinogenic fumes at vehicle refueling at existing and projected filling stations has been demonstrated, which will reduce air pollution in the working area for the filling stations workers and the environment of adjacent residential buildings, which will meet the EU directives (2008/50 / EC, 21.05, 2008; 2004/42 / EU, April 21, 2004; 1999/32 / EU, April 26, 1999; 98/70 / EU, May 21, 1998; 94/63 / EU, December 20, 1994) to the quality of gasoline, diesel fuel and control of the emissions from the filling stations, and the national legislation of Ukraine (SHR №173-96)..

Regulating E-cigarettes in India: A conundrum for the global giant in tobacco production.

Electronic cigarettes which are termed as e-cigarettes, e-cigs or e-vaporizers are used by the people for creating the inhalable aerosol which carries nicotine in it. Also, commonly referred as vaping. E-cigarettes are used as an alternative to the regular cigarettes and aids in the cessation of smoking. However, there has been tough strife and debate regarding e-cigarettes that are accompanied in the media stories which bring different opinions among consumers, experts as well as regulators who are involved in making decisions from no regulation to regulating e-cigarettes to banning of e-cigarettes which will bring direct impact on public health. In this article, an overview about the controversy of e-cigarettes with respect to the device, its market, regulation norms of e-cigarettes at different platforms and amidst the debate over e-cigarettes banning in India has been portrayed. It is surveyed that India being a hub of around 110 million tobacco smokers and a global giant in tobacco production, where the Indian government is planning to bring a complete ban over e-cigarettes throughout the country propels an elementary question of banning safer alternatives and not regular cigarettes which makes no sense from the point of banning e-cigarettes until or unless regular cigarettes are banned. Varying point of views from experts, scientists, users with respect to e-cigarettes has been addressed which shares a mix opinion with the supporters promoting ban as well as the antagonist with the concept of regulating the e-cigarettes in India.

Changes in US mass shooting deaths associated with the 1994-2004 federal assault weapons ban: Analysis of open-source data.

BACKGROUND: A federal assault weapons ban has been proposed as a way to reduce mass shootings in the United States. The Federal Assault Weapons Ban of 1994 made the manufacture and civilian use of a defined set of automatic and semiautomatic weapons and large capacity magazines illegal. The ban expired in 2004. The period from 1994 to 2004 serves as a single-arm pre-post observational study to assess the effectiveness of this policy intervention. METHODS: Mass shooting data for 1981 to 2017 were obtained from three well-documented, referenced, and open-source sets of data, based on media reports. We calculated the yearly rates of mass shooting fatalities as a proportion of total firearm homicide deaths and per US population. We compared the 1994 to 2004 federal ban period to non-ban periods, using simple linear regression models for rates and a Poison model for counts with a year variable to control for trend. The relative effects of the ban period were estimated with odds ratios. RESULTS: Assault rifles accounted for 430 or 85.8% of the total 501 mass-shooting fatalities reported (95% confidence interval, 82.8-88.9) in 44 mass-shooting incidents. Mass shootings in the United States accounted for an increasing proportion of all firearm-related homicides (coefficient for year, 0.7; p = 0.0003), with increment in year alone capturing over a third of the overall variance in the data (adjusted R = 0.3). In a linear regression model controlling for yearly trend, the federal ban period was associated with a statistically significant 9 fewer mass shooting related deaths per 10,000 firearm homicides (p = 0.03). Mass-shooting fatalities were 70% less likely to occur during the federal ban period (relative rate, 0.30; 95% confidence interval, 0.22-0.39). CONCLUSION: Mass-shooting related homicides in the United States were reduced during the years of the federal assault weapons ban of 1994 to 2004. LEVEL OF EVIDENCE: Observational, level II/IV.

Academic Influence and Its Relationship to Industry Payments in Orthopaedic Surgery.

BACKGROUND: The Hirsch index (h-index) quantifies research publication productivity for an individual, and has widely been considered a valuable measure of academic influence. In 2010, the Physician Payments Sunshine Act (PPSA) was introduced as a way to increase transparency regarding U.S. physician-industry relationships. The purpose of this study was to investigate the relationship between industry payments and academic influence as measured by the h-index and number of publications among orthopaedic surgeons. We also examined the relationship of the h-index to National Institutes of Health (NIH) funding. METHODS: The h-indices of faculty members at academic orthopaedic surgery residency programs were obtained using the Scopus database. The PPSA web site was used to abstract their 2014 industry payments. NIH funding data were obtained from the NIH web site. Mann-Whitney U testing and Spearman correlations were used to explore the relationships. RESULTS: Of 3,501 surgeons, 78.3% received nonresearch payments, 9.2% received research payments, and 0.9% received NIH support. Nonresearch payments ranged from $6 to $4,538,501, whereas research payments ranged from $16 to $517,007. Surgeons receiving NIH or industry research funding had a significantly higher mean h-index and number of publications than those not receiving such funding. Surgeons receiving nonresearch industry payments had a slightly higher mean h-index and number of publications than those not receiving these kinds of payments. Both the h-index and the number of publications had weak positive correlations with industry nonresearch payment amount, industry research payment amount, and total number of industry payments. CONCLUSIONS: There are large differences in industry payment size and distribution among academic surgeons. The small percentage of academic surgeons who receive industry research support or NIH funding tend to have higher h-indices. For the overall population of orthopaedic surgery faculty, the h-index correlates poorly with the dollar amount and the total number of industry research payments. Regarding nonresearch industry payments, the h-index also appears to correlate poorly with the number and the dollar amount of payments. These results are encouraging because they suggest that industry bias may play a smaller role in the orthopaedic literature than previously thought.

Regulating Cannabis Manufacturing: Applying Public Health Best Practices from Tobacco Control.

State legalization and regulation of cannabis, despite continued federal illegality, is a massive shift in regulatory approach. Manufactured cannabis, including concentrates, extracts, edibles, tinctures, topicals and other products, has received less attention than more commonly used dried flower, but represents emerging regulatory challenges due to additives, potency, consumption methods, and abuse and misuse potential. In November 2017, the California Department of Public Health (CDPH) released initial cannabis manufacturing regulations as part of a new state regulatory structure. As the largest U.S. medical cannabis market (and largest legal adult use market in the world beginning in 2018), California's regulatory approach will potentially influence national and global policy. Comparing CDPH's initial regulations to tobacco control best practices reveals that, while the regulations recognize the need to protect public health, prioritizing public health over business interests requires stronger approaches to labeling, packaging, and product formulations. Based on tobacco best practices, we recommend that cannabis regulations incorporate large and proportionately sized informational labels, a prominent universal cannabis symbol, rotating and pictorial health warnings, mandatory plain packaging, a comprehensive ban on characterizing flavors and addictive additives, and strict limits on the potency of inhalable products and those easily confused with non-cannabis products.

DNA labelling of varieties covered by patent protection: a new solution for managing intellectual property rights in the seed industry.

Plant breeders' rights are undergoing dramatic changes due to changes in patent rights in terms of plant variety rights protection. Although differences in the interpretation of ¼breeder's exemption«, termed research exemption in the 1991 UPOV, did exist in the past in some countries, allowing breeders to use protected varieties as parents in the creation of new varieties of plants, current developments brought about by patenting conventionally bred varieties with the European Patent Office (such as EP2140023B1) have opened new challenges. Legal restrictions on germplasm availability are therefore imposed on breeders while, at the same time, no practical information on how to distinguish protected from non-protected varieties is given. We propose here a novel approach that would solve this problem by the insertion of short DNA stretches (labels) into protected plant varieties by genetic transformation. This information will then be available to breeders by a simple and standardized procedure. We propose that such a procedure should consist of using a pair of universal primers that will generate a sequence in a PCR reaction, which can be read and translated into ordinary text by a computer application. To demonstrate the feasibility of such approach, we conducted a case study. Using the Agrobacterium tumefaciens transformation protocol, we inserted a stretch of DNA code into Nicotiana benthamiana. We also developed an on-line application that enables coding of any text message into DNA nucleotide code and, on sequencing, decoding it back into text. In the presented case study, a short command line coding the phrase ¼Hello world« was transformed into a DNA sequence that was inserted in the plant genome. The encoded message was reconstructed from the resulting T1 seedlings with 100 % accuracy. The feasibility and possible other applications of this approach are discussed.

Criminality and Asbestos in Industry.

Criminal prosecutions of individuals in the asbestos industry are reviewed, particularly the case of asbestos owner-executive Stephan Schmidheiny. Italian courts sentenced Schmidheiny to sixteen to eighteen years in jail for creating an environmental disaster causing three thousand deaths. The convictions were overturned on a technicality, and a murder case against Schmidheiny has started. His firm, Eternit, made asbestos-cement building products in many countries. Schmidheiny directed a cover-up that the Italian Court of Appeal blamed for delaying the ban of asbestos in Italy by ten years. Today, the asbestos industry is a criminal industry, profiting only by minimizing its costs for the prevention and compensation of occupational and environmental illness. The asbestos industry should only be consulted by governments for the purpose of closing it and dealing with the legacy of in-place asbestos.

Mechanisms of influence: Alcohol industry submissions to the inquiry into fetal alcohol spectrum disorders.

INTRODUCTION AND AIMS: Industry groups with vested interests in policy regularly work to protect their profits via the endorsement of ineffective voluntary regulation and interventions, extensive lobbying activity and minimising the health impact of consumption behaviours. This study aims to examine all alcohol industry submissions to the Australian House of Representatives Standing Committee on Social Policy and Legal Affairs into Fetal Alcohol Spectrum Disorders (FASD), to assist in understanding how those with vested interests contribute to policy development. The analysis aims to document the strategies and arguments used by alcohol industry bodies in their submissions and to compare these with known strategies of vested-interest groups. DESIGN AND METHODS: All 92 submissions to the Inquiry were screened to include only those submitted by alcohol industry bodies (five submissions). Content domains were derived based on the major themes emerging from the industry submissions and on common vested-interest behaviours identified in previous literature. RESULTS: The following content categories were identified: Concerns about FASD; Current industry activities and FASD prevention; Value of mandatory warning labels; and Credibility of independent public health researchers and organisations. DISCUSSION AND CONCLUSIONS: Alcohol industry submissions sought to undermine community concern, debate the evidence, promote ineffective measure which are no threat to the profit margins and attack independent health professionals and researchers. In doing so, their behaviour is entirely consistent with their responses to other issues, such as violence and chronic health, and copies the tactics employed by the tobacco industry. [Avery MR, Droste N, Giorgi C, Ferguson A, Martino F, Coomber K, Miller P. Mechanisms of influence: Alcohol industry submissions to the inquiry into fetal alcohol spectrum disorders. Drug Alcohol Rev 2016;35:665-672].

Underbanked: Cooperative Banking as a Potential Solution to the Marijuana-Banking Problem.

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this "underbanking" problem is a financial cooperative approach such as a cannabis-only financial cooperative. Even in light of federal anti-money laundering laws, this Note contends that the Federal Reserve is legally authorized to grant some cannabis-only financial cooperatives access to its payment system services under the Monetary Control Act of 1980.

Education versus regulation: The case for regulating the indoor tanning industry.

We examine marketing strategies for indoor tanning services that often target young adult females. Evidence of the addictive nature of indoor tanning suggests that young adults may be vulnerable to the promotion of indoor tanning and as a result deserve greater protection from the marketing of these services. As public awareness of the rising numbers of skin cancers linked to indoor tanning grows, we believe that the public will support increased regulation of this industry.

"Unleashed on an Unsuspecting World": The Asbestos Information Association and Its Role in Perpetuating a National Epidemic.

Examining previously underused corporate documents, we revisit the story of the Asbestos Information Association/North America, an industry trade group that sought in the early 1970s to counteract the growing public attention to, and government regulation of, asbestos as a serious threat to workers and consumers. From the mid-1960s through the early 1970s, according to its own spokesperson, asbestos was exposed as "probably the most hazardous industrial material ever unleashed on an unsuspecting world." In retrospect, thousands of lives may have been saved if the Asbestos Information Association had publicly acknowledged this earlier.

How does the alcohol industry attempt to influence marketing regulations? A systematic review.

AIM: To systematically review, using a qualitative, narrative synthesis approach, papers examining alcohol industry efforts to influence alcohol marketing policy, and compare with those used by the tobacco industry. METHODS: Literature searches were conducted between April and July 2011, and updated in March 2013. Papers were included if they: made reference to alcohol industry efforts to influence (a) policy debates concerning marketing regulations, (b) new specific marketing policies or (c) broad alcohol policy which included marketing regulations; were written in English; and concerned the period 1990-2013. Alcohol industry political activity was categorized into strategies/tactics and frames/arguments. Data extraction was undertaken by the lead author and 100% of the papers were fully second-reviewed. Seventeen papers met the review criteria. RESULTS: Five main political strategies and five main frames were identified. The alcohol industry argues against marketing regulation by emphasizing industry responsibility and the effectiveness of self-regulation, questioning the effectiveness of statutory regulation and by focusing on individual responsibility. Arguments relating to industry responsibility are often reinforced through corporate social responsibility activities. The industry primarily conveys its arguments through manipulating the evidence base and by promoting ineffective voluntary codes and non-regulatory initiatives. CONCLUSIONS: The alcohol industry's political activity is more varied than existing models of corporate political activity suggest. The industry's opposition to marketing regulation centres on claims that the industry is responsible and that self regulation is effective. There are considerable commonalities between tobacco and alcohol industry political activity, with differences due potentially to differences in policy contexts and perceived industry legitimacy.

First Amendment Limits on Compulsory Speech.

Government-mandated labeling requirements have a long history, and are used extensively by FDA in regulating the industries under its jurisdiction. All such requirements can be characterized as a form of "compelled speech," opening the door to First Amendment challenges. And some of these challenges, depending on the nature of the labeling requirement, have even been successful. Under Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, regulations that compel disclosure of information will, in many cases, merit only very limited First Amendment scrutiny­less, even, than most other regulations of commercial speech, which receive a type of "intermediate scrutiny." The labeling requirement that can best avoid or overcome a First Amendment challenge, therefore, will follow the example of the regulation described in Zauderer. For example, Zauderer applied its lower scrutiny by noting that the compelled speech at issue was a disclosure of "purely factual and uncontroversial information." Conversely, a successful First Amendment challenge to a labeling requirement will often involve an argument that the labeling requirement is outside the scope of what the Zauderer Court contemplated: so, for example, one may argue that a compelled disclosure is either "not factual" or else "controversial," putting it beyond Zauderer's reach. After briefly reviewing the major Supreme Court cases that establish the levels of scrutiny for commercial speech and compelled disclosures, the paper will discuss how the various elements of Zauderer have been analyzed by several lower courts, and how some courts have distinguished Zauderer in the context of labeling and other mandatory disclosure laws. In particular, the paper will focus on cases involving First Amendment challenges to food, tobacco, and drug labeling requirements­some successful, some not, and some ongoing­including cases challenging FDA, USDA, and state-level labeling requirements. The decided cases do not all agree on how to understand the elements of Zauderer­for example, must a disclosure be factually controversial to fall outside of Zauderer's limited review, or may it be factually unquestionable but relating to a controversial topic? What role, if any, should public acceptance, knowledge, and history play? What sorts of interests may the government invoke to justify a labeling requirement? Although some courts have taken (or at least hinted at) strict limits on the meaning of Zauderer, most courts have read Zauderer as applying somewhat more expansively to circumstances beyond its facts. The paper concludes that generally, courts have read Zauderer more expansively in part because such a reading is consistent with existing, familiar labeling requirements, and a narrow reading of Zauderer limited to its facts would rest on a slippery slope to abolishing many accepted and historically unquestioned labeling requirements. Any future attempts to expand judicial review of labeling requirements would do well to highlight limiting principles that address such concerns.

On Corporate Accountability: Lead, Asbestos, and Fossil Fuel Lawsuits.

This paper examines the use of lawsuits against three industries that were eventually found to be selling products damaging to human heath and the environment: lead paint, asbestos, and fossil fuels. These industries are similar in that some companies tried to hide or distort information showing their products were harmful. Common law claims were eventually filed to hold the corporations accountable and compensate the injured. This paper considers the important role the lawsuits played in helping establish some accountability for the industries while also noting the limitations of the lawsuits. It will be argued that the lawsuits helped create pressure for government regulation of the industries' products but were less successful at securing compensation for the injured. Thus, the common law claims strengthened and supported administrative regulation and the adoption of industry alternatives more than they provided a means of legal redress.