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The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power?Reputation and Powertraces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Powerdemonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

The American diet has changed dramatically since 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in food. Since then, thousands of chemicals have entered the food system. Yet their long-term, chronic effects have been woefully understudied, their health risks inadequately assessed. The FDA has been sluggish in considering scientific knowledge about the impact of exposures-particularly at low levels and during susceptible developmental stages. The agency's failure to adequately account for the risks of perchlorate-a well-characterized endocrine-disrupting chemical-to vulnerable populations is representative of systemic problems plaguing the regulation of chemicals in food. Today, we are faced with a regulatory system that, weakened by decades of limited resources, has fallen short of fully enforcing its mandates. The FDA's inability to effectively manage the safety of hundreds of chemicals is putting our children's health at risk.

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.

For both student food scientists and experienced professionals, a knowledge of U.S. food law is the foundation that supports an understanding of all industry regulation. Based on a popular internet course, Guide to Food Laws and Regulations, 2nd Edition informs students on the significance, range, and background of food laws and gives tools for finding current regulations.  This compact resource outlines major U.S. food laws, factors that led to their passage, and explains the role of key agencies like the FDA and FSIS in regulation and enforcement. Students are directed to internet sites as well as to indexes and resources available from the Federal government. Other topics include religious dietary law, Occupational Safety and Health Administration regulations, environmental regulations, HACCP and GMPs, laws governing health claims, and the regulation of biotechnology.  New to this edition are six chapters on subjects that have risen to prominence during the last few years: * Poultry Processing Regulations * Federal Trade Commission * Animal Welfare Regulations and Food Production * Egg Laws and Regulations * Catfish Regulations * Locating Laws and Regulations Guide to Food Laws and Regulations, 2nd Edition is an ideal sourcebook for students and professionals in food science and technology, chemistry, biosystems engineering, food animal production and medicine, agribusiness, and other closely related fields.

Both the National Institute of Environmental Health Sciences (NIEHS) and the U.S. Food and Drug Administration (FDA) work to promote and protect public health. The NIEHS achieves this mission by conducting research, including toxicological studies, on agents of public health concern through its intramural laboratories, the National Toxicology Program (NTP), grants and contracts to research labs across the country, and interagency agreements. The FDA, in turn, reviews and uses information from these and other studies and, where needed, performs studies of its own to develop standards to ensure that the products it regulates meet its requirements, maximizing product benefits while protecting the public from unacceptable risks.

In the United States, the Food and Drug Administration (FDA) provides public oversight of the safety and efficacy of drugs; medical devices; biologics like vaccines and blood products; cosmetics; radiation-emitting electronic products; veterinary products; and all foods, except meat and poultry (which are regulated by the Department of Agriculture). According to the FDA, the products it regulates account for more than one-fifth of U.S. consumer spending. In the area of medical products, the FDA is responsible for determining whether marketed products are both safe and effective before and after they have been marketed. In this paper, we will explore whether the policies of the agency itself are safe and effective. We stress two issues, one static and one dynamic. The static issue concerns the potential duplication inefficiency when product safety is protected not only by the FDA but also by the private sector through product liability law. Put another way, what is the rationale for using product liability and the FDA to regulate drug safety? While intuitively it may seem that two systems must be better than one in ensuring drug safety, each system comes with costs. We then turn to the dynamic issue, the speed–safety trade off, and consider the extent to which higher safety is achieved at a cost of later market entry of effective and even life-saving products. We assess the Prescription Drug User Fee Acts (PDUFAs), which increased the speed of the agency's regulatory process starting in 1992, although according to some, at the cost of reducing drug safety. We conclude by suggesting a research agenda for future work on the Food and Drug Administration.

Salmon and sunscreen may seem far removed from the world of cutting-edge drugs and medical devices. Yet both have been, at one time or another, part of the deal-making as the US Congress hashed out the details of the proposed Food and Drug Administration Safety and Innovation Act, currently making its way to the presidents desk for final approval. The legislation will renew a version of the Prescription Drug User Fee Act (PDUFA), which requires makers of new therapies to pay fees to support swift completion of the FDA approval process.

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode allows application of the Bootlegger and Baptist theory of regulation. Groups with divergent interests have aligned in support of cartelizing regulation of electronic cigarettes. As with other episodes of Bootlegger and Baptist coalitions, it is unclear whether the resulting policies will serve the public interest. There is evidence that electronic cigarettes pose substantially lower health risks than traditional cigarettes and may help smokers quit or reduce their tobacco consumption. Therefore, insofar as regulation restricts electronic cigarettes, it may undermine public health.

Legislation exists regulating adolescents' use of tanning beds; however, the rate at which adolescents use these devices has not been reduced. The purpose of this study was to provide an analysis of indoor tanning bed legislation in the United States specifically related to legal issues and parental consent along with enforcement of current laws. The investigators collected data via review of state health department websites or telephone interviews of identified contacts for all 50 states. Findings reveal wide variation in legislation related to adolescents' access to tanning devices and enforcement of violation of legal statutes. Nurses and other health care professionals can play key roles in educating families and adolescents to the dangers from the use of tanning beds along with being role models for proper skin protective behaviors. In addition, nurses should become advocates by supporting legislative efforts that ban tanning salons for all minors, with the long-term goal of reducing skin cancer caused by ultraviolet radiation (UVR) exposure from the use of tanning salons today.