Food and drug law journal最新文献

A prominent feature of statistical reasoning for nearly a century, the p-value plays an especially vital role in the clinical testing of new drugs. Over the last fifty years, the U.S. Food and Drug Administration (FDA) has relied on p-values and significance testing to demonstrate the efficacy of new drugs in the premarket approval process. This article seeks to illuminate the history of this statistic and explain how the statistical significance threshold of 0.05, commonly decried as an arbitrary cutoff, is a useful tool that came to be the cornerstone of FDA decision-making.

In a world where food allergy is still an incurable disease, law and regulation stand as necessary mechanisms to provide food-allergic consumers with the information they need to protect their health. The Food Allergen Labeling and Consumer Protection Act of 2004 provided specific labeling requirements for the “Top Eight” allergens in the U.S.: milk, soy, gluten, egg, tree nut, peanut, fish, and Crustacean shellfish. Since then, sesame has become more prevalent as an allergen and remains just as dangerous, inducing anaphylactic shock in some sesame-allergic individuals. Yet sesame remains unregulated, despite advocates and congressional members arguing for its inclusion. This note entertains one solution to this problem by exploring the most strategic way to bring a sesame allergy class action against a private food company under California’s consumer protection statutes. Because this kind of class action does not have much, if any, precedent, this note analyzes the basic, preliminary issues that any litigant would have to navigate around to certify a class, including preemption, standing, and the claim itself, by focusing on how courts have examined these issues in the recent “natural” class action litigation. It also analyzes the legal, moral, and practical aspects of choosing a type of relief, as well as whom to include in the class. Finally, this note briefly considers how FDA itself can ensure sesame is regulated on the labels of food products, given that some of the legal issues may well be insurmountable for this particular class action. This note explores the potential solutions to difficult legal hurdles in constructing a sesame allergy class action, arguing that litigating a sesame allergy class action—even if it is not ultimately successful—could start a productive conversation that might lead Congress or FDA to provide greater public health and consumer protection for those with sesame allergy.

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) requires tobacco companies to disclose information about the harmful chemicals in their products to the U.S. Food and Drug Administration (FDA). The law requires the FDA, in turn, to communicate this information to the public "in a format that is understandable and not misleading to a lay person." But how should the FDA comply with this requirement? What does it mean for information about complex chemicals to be "understandable and not misleading to a lay person"? These questions are not easy ones to answer. Disclosures about the amount of harmful chemicals (constituents) in different tobacco products may help to inform consumers, but may also conversely prompt consumers to reach incorrect or unsupported conclusions about products' relative health risks. This paper first analyzes the FDA's legal obligation to publish tobacco constituent information so that it is "understandable and not misleading to a layperson." Second, it discusses how that legal analysis has guided scientific research examining how members of the public interpret messages regarding tobacco constituents. Lastly, this paper concludes with policy recommendations for the FDA as it considers how to comply with the law's constituent disclosure requirement while still furthering its overall objective of promoting public health.

Food branded with a Natural label can be found in any grocery store across the United States. Consumers consider this label to be an important attribute when making a purchasing decision and billions of dollars are spent annually on these products. While many consumers believe Natural foods are healthier, heavy reliance on that assumption is misguided as “Natural” has no formal legal definition—it’s merely defined pursuant to an FDA approved informal policy. Another important health attribute in a consumer’s purchasing decision is the presence of natural flavors in food. However, unlike the term Natural, FDA has promulgated legally binding regulations for natural flavors. These flavors are currently the fourth most common food ingredient listed on food labels. In reality, “natural flavors” are a far cry from what consumers might expect, as they can contain both artificial and synthetic chemicals (often used as processing aids). Nonetheless, without a legally binding Natural regulation, there has been little opportunity to contest the naturalness of natural flavors in the past. Recently, FDA has initiated a notification of request for comments on use of the term Natural, so an attempt to promulgate regulations may be underway. Thus, it is appropriate to consider where natural flavors will fall if binding regulations are set forth. This article looks at the Natural debate, its history, and model regulatory standards worth considering. Within that context, it also provides a critical discussion concerning a misunderstood, yet federally regulated, ingredient that our society so heavily consumes: natural flavors.

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization jointly run by the Food and Agricultural Organization and the World Health Organization and GlobalG.A.P., a farm assurance program created in the late 1990s by supermarket chains and their major suppliers which has now expanded into a global certifying coalition. While Codex standards are adopted, often as written, by national food safety regulators who are principal drivers of the standard setting process, customers for agricultural products in many countries now demand evidence of GlobalG.A.P. certification as a prerequisite for doing business This article tests not only the durability and strength of private sector standard setting in the food safety system, but also the desirability of that system as an alternative to formal, governmental processes embodied, for our purposes, in the standards adopted by Codex. In many cases, official standards and GlobalG.A.P. standards clash in ways that implicate not only food safety but the flow of agricultural products in the global trading system. The article analyzes current weaknesses in both regimes and possibilities for change that will better reconcile the two competing systems.

We face a global antibiotics resistance crisis. Antibiotic drugs are rapidly losing their effectiveness, potentially propelling us toward a post-antibiotic world. The largest use of antibiotics in the world is in food-producing animals. Food producers administer these drugs in routine, low doses—the types of doses that are incidentally the most conducive to breeding antibiotic resistance. In general, individual countries have been too slow to act in regulating misuse and overuse of antibiotics in foodproducing animals. This problem will only worsen with the significant projected growth in meat consumption and production expected in emerging economies in the near future. Although individual countries regulating antibiotics can have important effects, one country alone cannot insulate itself entirely from the effects of antibiotic resistance, nor can one country solve the crisis for itself or for the world. The global nature of the food system and the urgency of the problem require immediate global solutions. Adapting a democratic experimentalist approach at the international level can help achieve this goal. Using an international democratic experimentalist framework in conjunction with the World Organization for Animal Health (OIE) would provide for increased systematized data collection and lead to heightened, scientifically informed OIE standards, enforceable by the World Trade Organization (WTO), which could have a significant impact on the reduction of subtherapeutic use of antibiotics internationally. International democratic experimentalism addresses the global intricacy, time sensitivity, context- and culture-specificity, and knowledgeintensiveness of this problem. By encouraging more countries to experiment to solve this problem, the democratic experimentalist model would help develop a larger database of solutions to enable more meaningful cross-country comparisons across a wider range of contexts. This approach maintains democratic governance and legitimacy while maximizing data collection, efficiency, translatability, transparency, and information-sharing. Adapting democratic experimentalism internationally can enable the kind of concerted international effort required to address the pressing problem of antibiotic resistance.