Cultivating Evidence-Based Pathways for Cannabis Product Development: Implications for Consumer Protection†

Disparities between federal and state cannabis regulation, coupled with protracted federal enforcement, have facilitated the proliferation of a multi–billion dollar cannabis industry that generally evades compliance with federal consumer protection laws. The Federal Food, Drug and Cosmetic Act (FDCA) established regulatory pathways for the lawful development of products such as food, drugs, and dietary supplements. The FDCA uses a science-based approach to protect consumers from harmful products, but early inconsistencies between state and federal cannabis regulation prevented and/or discouraged the cannabis industry from complying with FDCA requirements. Cannabis products are promoted as safe and attributed with providing effective therapeutic treatment for numerous medical conditions, yet the claims often lack the rigorous evidence-based support typically expected by regulators and the medical community. The Food and Drug Administration (FDA) has announced its expectation that cannabidiol (CBD) products comply with the FDCA and follow a science-based approach to product development. The FDA is addressing violations involving unsubstantiated CBD health claims and is working to clarify the future regulatory pathway for CBD products. Meanwhile, the state-approved cannabis market continues to operate, selling numerous products that have circumvented the FDCA consumer protections. This article examines the need for strengthening consumer protections in the cannabis market. We use evidence-based medicine as a model to address the importance of science-based product development and to contextualize a science-based comparison of regulatory pathways for cannabis drugs, food, and dietary supplements.     

补强证据的论证可视化工具

本文研究了如何以图形很好地展示补强证据时出现的几个问题。不同的可视化软件系统在展示此类证据时所采用的方法各不一样，从这个角度对它们进行比较具有积极意义。通过把补强证据图形化，可以更清晰地看到这些问题，以帮助解决如何避免重复计算错误之类的问题。     

Reviews

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Political development and economic development: A regional assessment of contemporary theories

Conclusion This paper has been devoted to an assessment of contemporary theories of political and economic development. Specifically, it operationalized and evaluated the hypotheses of the most influential current approach referred to as developmental theory. A comparative study of four regional areas in Latin America concluded that this theory was conceptually and empirically inadequate to the task of explaining the results. Although the theory of structured underdevelopment was not specifically addressed by the research design, it did conform better to the results and suggested an alternative theoretical statement. The hypothesis put forward for subsequent evaluation stresses structural factors related to comprehensive and coordinated organizational forms which, in turn, are explicitly related to varieties of economic development.     

Defining Corruption Where the State is Weak: The Case of Papua New Guinea

Corruption is often defined as the abuse of public office for private gain. This article suggests that this is inadequate for understanding corruption in weak states and presents two broader definitions of the concept. It discusses findings from qualitative and quantitative research conducted in Papua New Guinea in light of these definitions. Respondents – particularly the poor and marginalised – saw corruption as tied to the actions of public officials as well as non-state actors. It is argued that applying broader definitions of corruption could help researchers and policy makers better understand citizens’ concerns about corruption, particularly where the state is weak.     

Nanomanipulation‐Coupled Nanospray Mass Spectrometry Applied to the Extraction and Analysis of Trace Analytes Found on Fibers*

Abstract: This article presents the novel instrumentation of nanomanipulation coupled to nanospray ionization‐mass spectrometry, which is used to directly probe trace analytes found on individual fibers. The low detection limits and sample volumes associated with nanospray ionization‐mass spectrometry make it the ideal instrument to implement for trace analysis. Nanospray ionization‐mass spectrometry, coupled with the nanomanipulator, allows for the direct probing of trace particulates on fibers. The technique is demonstrated by dissolving an electrostatic particle of cocaine from a fiber, collecting the analyte solution in a nanospray tip, and transferring the tip directly to the mass spectrometer to complete analysis. The utility of this technique is evident through the minimal sample preparation and short analysis time. The use of nanomanipulation coupled to nanospray ionization‐mass spectrometry could improve on current trace particulate analysis by reducing both detection limits and sample size required to complete analysis.