Joanna K. Sax’s research while affiliated with California Western School of Law and other places

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to recommend Emergency Use Authorization (‘EUA’) of the COVID-19 vaccine for children ages 5–11. The results of the study demonstrate that most comments opposed EUA and these comments were associated with statements that indicated misperceptions of risk. Findings provide interesting insights regarding the role of public comments generally but also suggest that the public participation process in notice and comment can be modified to serve as an intervention to align individual perceptions of risk more closely with evidence-based assessment of risk. In addition, the findings provide opportunities to consider strategies for public health messaging.

Decreasing smoking initiation remains a public health priority. In 2016, California, in the United States, enacted the Tobacco 21 law, which raised the minimum age for the purchase of tobacco products from age 18 to age 21. This paper evaluates whether the enactment and implementation of the Tobacco 21 law changed how young adults perceive the risk(s) of smoking. Data were drawn from a cohort of emerging adults (n = 575) in California who were non-daily smokers at enrollment and followed quarterly for 3 years. Data were collected during 2015–2019. Piecewise multilevel regression models were used to test for changes in smoking status and perceived risks of cigarettes after Tobacco 21 enforcement began. Findings indicated that the prevalence of current smoking and perceived risks of smoking both declined following Tobacco 21 implementation (ps < 0.001). Post-hoc analyses suggested that post-implementation changes in perceived risk occurred primarily among ongoing smokers. Findings suggest that Tobacco 21 and associated public health measures have been effective, but additional research is needed to disentangle the effects of specific components. Understanding the impact and efficacy of tobacco laws provides great social value to research and implement policies that create intervention(s) on reducing tobacco use initiation.

This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow policymakers to understand individual misperception of risk as compared to evidence-based assessment of risk. Vaccine-hesitant individuals assign a high risk to the COVID-19 vaccine and a low risk to the disease—a perception that is disconnected from the science. The backbone of this Article is the timeline of the COVID-19 pandemic and the underlying science of the disease and vaccines. The timeline provides a factual background to demonstrate how vaccine hesitancy to the COVID-19 vaccine emerged. The instant pandemic also demonstrates changes in how individuals see themselves in society, receive information, and are persuaded by economic forces. This Article combines the individual’s decision-making process with modern day variables to suggest interventions that can undo anti-vaccine damage. While the novelty of the normative framework provided herein is instructive for current COVID-19 vaccine hesitancy issues, this framework can be applied to other areas in which individual’s perceptions of risk are disconnected from evidence-based assessment of risk.

Certain advances in biotechnology generate controversy, with consumer resistance derived from publicly expressed concerns about safety, despite scientific evidence of safety. The reasons for this discrepancy are not fully understood. This study aimed to understand how participants respond to biotechnology when some ambiguity about risk or uncertainty is presented. A sample of 318 adults completed a survey assessing aversion to ambiguous information in controversial areas such as food, vaccines, fluoridated water, and stem cell research. Participants responded to ambiguity assessments and 14 scenarios in these categories that contained a description of a benefit and either missing or conflicting information about an unknown risk or uncertainty. Participants who reported greater aversion to ambiguity tended to respond in a way that signals the assignment of high risk, and low benefit, when presented with some unknown or uncertain risk. The results of the present study can be used to develop methods to close the divide.

We live longer and healthier lives because advances in science create easier and better ways to sustain and survive. Society has an intricate relationship with biotechnology. Vaccines save lives. Fluoridated water decreases dental issues. Antibiotics treat bacterial infections. Nuclear power is a form of clean energy. With any emerging technology, the benefits do not exist in a vacuum, thus, negative consequences result as well. Our widespread uses of antibiotics are creating antibiotic-resistant strains of bacteria. Our research into nuclear energy also facilitated the creation of nuclear bombs. Perhaps it is human nature to use scientific advances for good and for bad. Acknowledging the reality that advances in science lead to both positive and negative consequences, we have to analyze the trade-offs in order to implement sound policy.Food from genetically modified organisms (GMOs) and genetically engineered (GE) food (collectively “GE”) provides a prime example where advances in biotechnology are available to address a variety of issues in our food supply. GE food is in a major cross-hair in the public debate—although much of the public debate fails to fully acknowledge the contours of issues facing our food supply and the environment, and so it is in a sense a misguided public debate. Disconnect between the public debate and scientific knowledge is not new; unfortunately, many examples exist to highlight the scientific community’s failure to fully educate the public. The GE debate appears to have an added layer of complexity: mass marketing to consumers suggesting that GE food is unsafe, harmful and bad for the planet. These marketing campaigns engage emotion, for example, that consumption of GE food will harm children. These anti-GE marketing campaigns prey on the emotions of the consumers, as many marketing campaigns do. This swelling of the emotional response to GE foods is very difficult to overcome. This Article attempts to provide context and scientific support for discussing the challenges to our food supply. Addressing the issues in our food supply is critical, but the discussion has to be based on facts—and these facts must inform our regulatory policies. To do this, this Article provides an overview of the scientific literature on conventional and GE food, attempts to understand the emotional response to GE food, and provides a frame of focus for regulatory policies.

The food supply is complicated and consumers are increasingly calling for labeling on food to be more informative. In particular, consumers are asking for the labeling of food derived from genetically modified organisms (GMO) based on health, safety, and environmental concerns. At issue is whether the labels that are sought would accurately provide the information desired. The present study examined consumer (n = 181) perceptions of health, safety and the environment for foods labeled organic, natural, fat free or low fat, GMO, or non-GMO. Findings indicated that respondents consistently believed that foods labeled GMO are less healthy, safe and environmentally-friendly compared to all other labels (ps <.05). These results suggest that labels mean something to consumers, but that a disconnect may exist between the meaning associated with the label and the scientific consensus for GMO food. These findings may provide insight for the development of labels that provide information that consumers seek.

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as ‘natural.’ This leads many consumers to fail to question the supplements' safety, and some consumers even equate ‘natural’ with safe. But, ‘natural’ does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco—a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Law has a unique interaction with the advancement of biomedical science. Our society depends on advances in science in many different ways. This article focuses on biomedical science, or the science related to the study of disease. Our ability to treat and fight human ailments benefits society. In general, we live longer and healthier lives and this is due, in large part, to advances in biomedical research and medicine. Each year, Congress allocates money to various departments to fund biomedical research; the National Institutes of Health (NIH) receives the bulk of the money. In 2012, the NIH’s budget was $30.9 Billion. The NIH then allocates this money to researchers throughout the country via a competitive grant process. In general, the money given to the NIH is non-allocated, which means that the NIH decides how the money is spent. Congress and the President, however, may include directives as to how they would like the money spent or even limit or eliminate certain research questions. Studies have shown that these directives have a large impact in how the NIH allocates its budget. It is these directives, which may be politically motivated that can interfere with the scientific process of determining which questions need to be answered. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains empirical studies to support the hypothesis that political activity in framing scientific inquiry can negatively impact scientific progress and integrity in biomedical research. This article utilizes the data from the empirical studies and then analyzes contemporary law and economics models to demonstrate that there are process defects in the interaction of law and science. Using public choice theory as the basis, this model helps to explain the process defect but cannot be used to resolve it. Instead, this article articulates reasons why scientific inquiry should have an autonomous zone and that the government should play a limited role in oversight. This article proposes solutions to balance the roles of elected officials with the expertise of scientists.

Little is known about adverse reactions to dietary supplements because these events are underreported. The Food and Drug Administration’s ability to regulate dietary supplements has a long and complicated history and the battle over regulation continues. On a simple level, the debate over regulation of dietary supplements boils down to manufacturers’ desire not to be regulated and personal autonomy to make decisions about what supplements to take versus the FDA’s charge to protect the public from harmful drugs and devices. At present, dietary supplements are regulated as food, not drugs. The arguments surrounding this debate fall along a spectrum. These arguments, however, are reminiscent of the debates surrounding the regulation of tobacco. The tobacco companies fought hard to keep the FDA out of regulation, some members of the public argued that they should be allowed to take personal responsibility, and the FDA fought to bring tobacco within its regulatory authority. This article seeks to re-examine the debate over dietary supplement regulation through the lens of lessons learned from the tobacco industry. This article proposes new approaches and concerns regarding the future of the FDA and its role in regulating the dietary supplement industry.