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.