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Contents - AJLM - 2015 Volume 41: 2 & 3
Full Journal
  1. Full Download
Table of Contents
  1. Table of Contents
Symposium Articles
  1. Genetically Modified Foods at the Intersection of the Regulatory Landscape and Constitutional Jurisprudence
  2. Inappropriate Referral: The Use of Primary Jurisdiction in Food-Labeling Litigation
  3. The Implementation of the Food Safety Modernization Act and the Strength of the Sustainable Agriculture Movement
  4. The Illusion of Autonomy in "Food" Litigation
  5. Deregulation, Distrust, and Democracy: State and Local Action to Ensure Equitable Access to Healthy, Sustainably Produced Food
  6. Transparency for Food Consumers: Nutrition Labeling and Food Oppression
  7. What's in Store: A Vision for Healthier Retail Environments through Better Collaboration
  8. Addressing Consumer Confusion Surrounding "Natural" Food Claims
  9. Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer
  10. The Food Safety Modernization Act: Implications for U.S. Small Scale Farms
  11. The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role
  12. A Coordinated Approach to Food Safety and Land Use Law at the Urban Fringe
  13. Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation
  14. If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production
  15. Repositioning Generics: The Comparative Value of Liability in FDA's Proposed Rule on Labeling
Recent Court Decisions
  1. Recent Case Developments: First Circuit Certifies Class for Third Party Payors and Individual Consumers in Pharmaceutical "Pay-For-Delay" Case
  2. Recent Case Developments: Chickens and the Constitution: How California Hens are Ruffling Feathers
Full Journal
Full Download
AJLM - [PDF]


Table of Contents
Table of Contents
Symposium Articles
Genetically Modified Foods at the Intersection of the Regulatory Landscape and Constitutional Jurisprudence
Saby Ghoshray - [PDF]

Breakthrough advancement in genetic engineering has ushered in a new era. An era where, unbeknownst to us, our diets may contain food derived from genetically engineered ("GE") substances or genetically modified organisms ("GMOs"). Such genetically modified ("GM") foods have been introduced into the existing food distribution system without adequate warning to consumers. This inability to know about the foods consumers eat or the health risks they face is the stark reality of our contemporary food pyramid system. Within this system, the consumer resembles the participant in a blind experiment; the participant neither knows of nor consents to the participation. Emboldened by a two-prong transformation process, gene transfer between species and adapting bio-technological research into everyday application, modern agriculture manifests itself in a pervasive commoditization of GM foods. The resulting uncertainty faced by the consumers of such commoditization can be traced to two distinct legal inadequacies: the supervisory regulatory mechanism's inability to protect public interest and existing law's inadequacy to issue appropriate labeling information for GM foods.
Inappropriate Referral: The Use of Primary Jurisdiction in Food-Labeling Litigation
Diana R. H. Winters - [PDF]

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."
The Implementation of the Food Safety Modernization Act and the Strength of the Sustainable Agriculture Movement
Samuel R. Wiseman - [PDF]

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 Illusion of Autonomy in "Food" Litigation
Paul A. Diller - [PDF]

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.
Deregulation, Distrust, and Democracy: State and Local Action to Ensure Equitable Access to Healthy, Sustainably Produced Food
Lindsay F. Wiley - [PDF]

Our food system-the food that's available in stores, restaurants, schools, workplaces, and our homes; how it is produced and sold; how it is consumed and by whom-has crucial implications for our health and our environment. Converging food reform movements are fostering coalitions among environmental, public health, alternative food, and food justice advocates who share an interest in equitable access to healthy, sustainably-produced food. Working together, these groups are increasing access to fresh fruits and vegetables through incremental agricultural subsidy and nutrition assistance reforms.
Transparency for Food Consumers: Nutrition Labeling and Food Oppression
Andrea Freeman - [PDF]

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.
What's in Store: A Vision for Healthier Retail Environments through Better Collaboration
Christine Fry, Ian McLaughlin, Alexis Etow, and Rio Holaday - [PDF]

In 1903, the New York state legislature considered requiring grocers to close on Sundays in response to demands from religious groups. L.J. Callanan, a grocer in New York City, spoke out against this proposal in a letter to the editor of the New York Times, noting the importance of small grocers to communities and the challenges of running a low-margin business. Today, just as in 1903, small food retailers-corner stores, gas stations, and convenience stores-continue to operate on thin margins and play a substantial role in their communities. They include the place around the corner where one grabs a pack of cigarettes, the peddler of snacks to kids on the way home from school, and the one-stop shop for a six-pack and a few gallons of gas on the way home from work.
Addressing Consumer Confusion Surrounding "Natural" Food Claims
Efthimios Parasidis, Neal Hooker, and Christopher T. Simons - [PDF]

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 Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer
Joanna K. Sax - [PDF]

A lot of justifiable concern is spent on the quality and safety of our food supply. In 2011, the FDA Food Safety and Modernization Act (FSMA) was signed into law. The FSMA provides the Food and Drug Administration (FDA) with a legislative mandate to enforce preventative measures to shore-up our food system and improve safety. Under the FSMA, the FDA has the authority to act in the following key areas: to prevent contamination of foods, to respond to potential food safety issues, to improve food importation standards, and to create partnerships to ensure the safety of our food supply.
The Food Safety Modernization Act: Implications for U.S. Small Scale Farms
Kathryn A. Boys, Michael Ollinger, and Leon L. Geyer - [PDF]

The United States Centers for Disease Control and Prevention (CDC) estimates that 48 million instances of foodborne illnesses occur each year resulting in 128,000 hospitalizations and 3,000 deaths. The value of medical costs, productivity losses, long-term mental and other health impacts, and the costs of premature deaths stemming from these events are substantial. Illnesses attributable to the fourteen pathogens that account for a majority of foodborne illness have recently been estimated to cost the United State economy $14 billion and cause of loss of 61,000 quality-adjusted life years (QALY) annually.
The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role
Sam F. Halabi - [PDF]

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." Part of its plan for fulfilling its Section 305 obligation is actual presence: FDA has established overseas offices in China, India, Costa Rica, Chile, Mexico, Belgium, the UK, Italy, South Africa, and Jordan (closed). A separate aim is to incorporate the work and insights from international organizations ranging from the Food and Agriculture Organization to the World Health Organization to the World Bank to the OECD. The FSMA statute specifies one particular international organization for FDA attention with respect to its global activities: the Codex Alimentarius Commission ("Codex").
A Coordinated Approach to Food Safety and Land Use Law at the Urban Fringe
Stephen R. Miller - [PDF]

Over the past several decades, a resurgent interest in food has brought agricultural production into American cities. Just as in Voltaire's classic work, Candide, where the namesake character travels the world over only to decide it is best to be at home "cultivat[ing] our garden," so, too, have many urban and suburban dwellers found great interest in locally grown food. Manifestations of this boom include the rise of farmer's markets and community gardens, as well as the proliferation of urban agriculture ordinances. Such ordinances typically include provisions allowing urbanites to keep chickens, grow gardens in their front yards, and engage in micro-scale agricultural production, ordinarily for personal use and, occasionally, for sale at farmer's markets and neighborhood use. What has received less attention is an emergent boomerang effect of this movement: while the first wave of urban agriculture has brought agriculture to the cities, city dwellers increasingly want to go to rural areas to visit agriculture in its native habitat. Wine drinkers want to visit the vineyards of their favorite wine; raw milk purchasers want to visit the farmer and the cows that made their milk; organic produce lovers want to have farm-to-table dinners in barns just feet from where the food was grown; meat lovers want to purchase beef directly from the rancher who raised-and slaughtered-the animal. Different names have been given to the movement, such as agritourism or, sticking with the contemporary movement's Italian antecedents, agriturismo. Those who take to the movement had been called the "new agrarians" and "urbanistas." But none of these names capture the essence of the exploding, but nascent, movement at the rural urban fringe. Indeed, the very rise of the movement is as if today's modern Candides had decided not simply that the best of all possible worlds was in the tending of gardens, but in the tending of foodsheds. As such, the regulatory structures that need revisiting are not just those of urban and suburban areas, but the rural areas to which the local food movement now turns.
Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation
Stephanie Tai - [PDF]

The current federal food regulatory system is highly fragmented. In 2007, the U.S. Government Accountability Office published a comprehensive report on fragmentation in food safety governance, entitled "Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System." The report highlighted a number of areas of food safety fragmentation, drawing attention to the fifteen federal agencies administering thirty laws related to food. For example, differences in agency jurisdiction can arise from something as arbitrary as packaging, with open-faced sandwiches being regulated by the U.S. Department of Agriculture (USDA), and packaged sandwiches being regulated by the Food and Drug Administration (FDA). Moreover, the report pointed out that differences in agency jurisdiction can result in different regulatory and enforcement authority, with foods under FDA authority being marketable without prior approval, but foods under USDA authority requiring continuous inspection. Finally, these agencies have overlapping activities but do not share resources for conducting those activities; for example, the USDA and the FDA do not share resources even though they both inspect imported food shipments at eighteen ports of entry.
If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production
Christine Donovan - [PDF]

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 underregulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.
Repositioning Generics: The Comparative Value of Liability in FDA's Proposed Rule on Labeling
Nicholas Falcone - [PDF]

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 4—today, they fill about 80% of prescriptions nationwide.
Recent Court Decisions
Recent Case Developments: First Circuit Certifies Class for Third Party Payors and Individual Consumers in Pharmaceutical "Pay-For-Delay" Case
Sudeshna Trivedi - [PDF]

In re Nexium Antitrust Litigation - On January 21, 2015, the U.S. Court of Appeals for the First Circuit certified a class action brought by third party payors ("TPPs") and individual consumers against pharmaceutical companies engaging in reverse payment settlement agreements. Under a reverse payment settlement agreement, a patentee compensates an alleged infringing party for refraining from entering the patentee's market.3 In re Nexium is the first reverse-payment-settlement-agreement class action that has been certified and has survived on appeal since the landmark Supreme Court decision in FTC v. Actavis, Inc.
Recent Case Developments: Chickens and the Constitution: How California Hens are Ruffling Feathers
Portia S. Keady - [PDF]

The Attorneys General of Iowa, Nebraska, Oklahoma, Kentucky and Alabama ("Plaintiffs") are currently fighting the validity of a California law requiring all whole eggs sold in California to come from hens housed in cages that allow the hens to stand up, fully extend their limbs and turn around freely. Plaintiffs allege that the California law violates the U.S. Constitution under the Commerce and Supremacy Clauses. To date, Plaintiffs' substantive claims have not been addressed because the U.S. District Court for the Eastern District of California granted Defendant State of California's motion to dismiss for lack of standing. The district court held that the relevant parties to this action were the egg farmers, not the citizens of each state, and that this was an issue for private action. However, Plaintiffs appealed the decision on March 11, 2015 and the case is now pending before the U.S. Court of Appeals for the Ninth Circuit.