Food system regulation must negotiate intensely individual and hyper-local preferences with the national and collective implications of food production and consumption. The regulatory scheme permits the coincidence of multiple sets of regulators, and there is an active interchange between federal and state authorities. This kind of “dynamic” or “polyphonic” federalism entails “the interaction of multiple independent voices” and “the dynamic interaction among states and the national government.”

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents.

The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the “sustainable agriculture” or “small farm” movement), to three aspects of the FDA's proposed rules—involving manure application, on-farm packing activities, and exemptions for very small farms—to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here—exemptions for very small farms—the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations, and yet prevailed. This suggests that the high salience of locavore and “slow food” issues might have allowed relatively small, dispersed interests to overcome traditional obstacles to political organization, and that the sustainable agriculture movement has indeed become an effective political force.

Behavioral scientists have understood for decades that when it comes to food, we are anything but fully autonomous. One's choice of what and how much to eat is strongly influenced by environment and context. Give someone a larger bowl and serving spoon, and he will unwittingly eat more ice cream than if he used a smaller bowl and spoon. A person will eat more if out with friends, and may eat less if eating at a leisurely pace. The food industry has been fully aware of this science for decades; indeed, its scientists have been among the leading researchers in the area. Using this science to its advantage, the industry has manipulated the appearance, smell, taste, texture, and packaging of food to get Americans to eat more of the foods the industry sells, with often devastating consequences for the public health.

Environmental, public health, alternative food, and food justice advocates are working together to achieve incremental agricultural subsidy and nutrition assistance reforms that increase access to fresh fruits and vegetables. When it comes to targeting food and beverage products for increased regulation and decreased consumption, however, the priorities of various food reform movements diverge. This article argues that foundational legal issues, including preemption of state and local authority to protect the public's health and welfare, increasing First Amendment protection for commercial speech, and eroding judicial deference to legislative policy judgments, present a more promising avenue for collaboration across movements than discrete food reform priorities around issues like sugary drinks, genetic modification, or organics. Using the Vermont Genetically Modified Organism (GMO) Labeling Act litigation, the Kauai GMO Cultivation Ordinance litigation, the New York City Sugary Drinks Portion Rule litigation, and the Cleveland Trans Fat Ban litigation as case studies, I discuss the foundational legal challenges faced by diverse food reformers, even when their discrete reform priorities diverge. I also explore the broader implications of cooperation among groups that respond differently to the “irrationalities” (from the public health perspective) or “values” (from the environmental and alternative food perspective) that permeate public risk perception for democratic governance in the face of scientific uncertainty.

Transparency for consumers through nutrition labeling should be the last, not the first, step in a transformative food policy that would reduce dramatic health disparities and raise the United States to the health standards of other nations with similar resources. Nonetheless, transparency in the food system is a key focal point of efforts to improve health by providing consumers with necessary information to make good nutritional choices, as well as to achieve sustainable food chains and ensure food safety and quality. In fact, nutrition labeling on packaging and in restaurants is the centerpiece of policy designed to decrease obesity, a condition many health advocates consider to be the most urgent public health crisis of the twenty-first century. The resulting increased transparency about food ingredients has led to some changes in industry practices and allowed many middle- and upper-income consumers to make informed choices about the products they purchase and consume. Unfortunately, however, research reveals that increased nutritional information does not improve health.

Use of “natural” and “all natural” claims on food and beverage products has increased exponentially over the last decade. Studies have consistently found that the claims influence consumer behavior—consumers seek out and are willing to pay a premium for products that make Natural claims. Not surprisingly, the Natural market has grown significantly, surpassing $40 billion in annual revenues. Despite strong consumer demand for Natural products, a majority of consumers have mistaken beliefs about the meaning of Natural claims.

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.

The Food Safety Modernization Act (FSMA) reforms law governing the safety of human and animal foods produced for consumption in the United States. Recognizing the challenges that the proposed regulations would impose on small farms, Congress included an amendment to exempt small farms from the full scope of FSMA requirements. This special treatment and other issues left unaddressed by FSMA, however, present challenges for buyers of small farm products and is inducing a private sector response to these regulatory gaps. This Article reviews the current treatment of small farms under FSMA and explores some key impacts and implications of FSMA on these organizations. Particular consideration is given to the unintended consequences of the Tester-Hagan Amendment and the unaddressed issue of liability for foodborne illness.

The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

Much has been written about the rise of the local food movement in urban and suburban areas. This essay tackles an emerging outgrowth of that movement: the growing desire of urban and suburban dwellers to engage rural areas where food is produced not only to obtain food but also as a means of tourism and cultural activity. This represents a potentially much-needed means of economic development for rural areas and small farmers who are increasingly dependent on non-farm income for survival. The problem, however, is that food safety and land use laws struggle to keep up with these changes, waffling between over-regulation and de-regulation. This essay posits a legal path forward to steer clear of regulatory extremes and to help the local food movement grow and prosper at the urban fringe. We must cultivate our garden.

— Candide, or Optimism

With respect to addressing food safety—and food system issues in a more general sense—coordination in regulatory approaches can be critical. As a recent Washington Post article stated,

Approximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness. A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat. The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as “largely preventable.” It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks. Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States under-regulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.

Generic drugs occupy a unique position in the U.S. pharmaceuticals market. On one hand, generics are a product of basic free-market economic reasoning. Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) based on the uncontroversial assumption that inexpensive generic competition would reduce prescription drug costs. On the other hand, the generic drug industry is primarily a regulatory creation; Hatch-Waxman facilitates generic competition by permitting generic manufacturers to rely heavily on prior expenditures of pioneer drug manufacturers, including those required to convince the Food and Drug Administration (FDA) that a drug is safe and efficacious. Propelled by federal law, generics have evolved from their minority market position as cheap alternatives to a “dominant” market position—today, they fill about 80% of prescriptions nationwide.