Regulating Functional Foods: Pre- and Post-Market Strategy

As best we understand the government, its first argument runs along the following lines: that health claims lacking significant scientific agreement are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous

Beyond Food or Drug: An Examination of Food and Drug Law Through a Study of Cannibalism

This paper attempts to explore some of the limitations within the Food, Drug and Cosmetics Act's definition of "food" and "drug". Much of the preexisting scholarly debate has focused on hybrids between foods and drugs, dietary supplements, vitamins, weight loss products and the like. This paper attempts to investigate our current problematic definitions of food and drug through the study of an unabashedly unorthodox subject: cannibalism. Our current regime attempts to classify a product by its “intended use.†However, many foods and drugs do not have a single intended use; they are ingested for a myriad of reasons, economic, cultural and religious. And because cannibalism has throughout history taken many different forms and has shown up on almost every continent, it acts as an excellent lens for focusing on what we might think the true limitations of the Act might be. Often times, the motivation that lay within the cannibals mind behind his consumption of human flesh was often one of simply eating a meal. In other tribes or other instances of history, some cannibals felt that eating people was the only way to treat illness, to prevent aging, cure leprosy or even blindness. However, not all instances of cannibalism fell into these simple acts of consuming a food, or administering a drug. Often times, cannibalism was an act of empowerment, of incorporation and self-realization; something that our FDCA doesn’t address. Arguably, a third category of comestible products must be recognized, one that is connected to our identity, our culture and ethnicity, our religion and our beliefs. Catholics who consume the Eucharist do not do so for its nutrition, nor for its medicinal effects. Native American Peyotists worship peyote and do not inhale it simply as a hallucinogenic drug. And arguably, when an American eats a hamburger or a hot dog or apple pie, he is not simply partaking of a meal, but of his own culture and identity. This paper argues that foods and drugs cannot be confined, limited or defined simply by their compositional, nutritional or medicinal value. There is cultural value to foods and drugs, and it seems reasonable to demand that the law recognize these values

Probiotics: Achieving a Better Regulatory Fit

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of microorganisms within and across individuals, they are also promoting interest in the development of probiotic products. NIH set aside a portion of HMP funds to study the Ethical, Legal, and Social Implications (ELSI) of the HMP’s scientific goals. Among the funded ELSI studies was an effort to look at the current regulatory framework for probiotics and to determine if it is a good fit for the range of probiotics that are on the market, under development, or that may be developed in the future as a result of the HMP. This article reports on the findings of a Working Group consisting of NIH-funded HMP scientists, physicians, legal academics, government regulators, industry and consumer representatives, bioethicists, food and drug lawyers, and health policymakers who were assembled to address the adequacy of the current regulatory framework for probiotics under the HMP ELSI funded project. Specifically, after discussion of the features of probiotics that are relevant to their regulation and an overview of FDA’s current regulation of probiotics, the article addresses the following questions: 1) Do current regulations adequately address the safety of new probiotic products? 2) Should probiotic foods and dietary supplements be classified as drugs and required to go through the drug approval process? 3) What types of product characterization requirements are appropriate for probiotics? 4) Are current claim regulations appropriate for probiotics and, if not, how might they be improved

Landing Preference and Reproduction of Rhopalosiphum padi (Hemiptera: Aphididae) in the Laboratory on Three Maize, Potato, and Wheat Cultivars

The bird cherry-oat aphid Rhopalosiphum padi (L.) transmits the nonpersistent Potato virus Y (PVY) to seed potatoes. Planting a nonvirus host plant around the main crop can reduce PVY incidence, because aphids tend to land in high numbers at the edge of a field and the crop border acts as a virus sink. This study determined R. padi landing and settling preferences and reproductive rates on three cultivars each of maize and wheat compared with potato in the laboratory as a basis for identifying an attractive crop border plant. Aphids were reared on maize and wheat to control for bias due to previous experience. Irrespective of origin, alates preferred to land almost exclusively on maize and wheat rather than on potato cultivars in choice experiments. Aphid settling on the maize and wheat cultivars depended on aphid origin. In no-choice experiments, R. padi produced the highest number of offspring on the wheat cultivars, irrespective of origin. Plant nitrogen content and trichome density did not influence R. padi reproduction. The study demonstrates that host plant preference of aphids may vary between plant cultivars and can therefore influence the effectiveness of a crop border. The high landing rate but low reproduction suggest that maize cultivars '6Q-121' and '78-15B' could be suitable crop border plants in regions where R. padi is abundant. Before testing potential crop border plants in the field, cultivars should be screened using aphid landing, settling and reproduction as selection criteria

Food, Drugs, and Droods: A Historical Consideration of Definitions and Categories in American Food and Drug Law

This article explores the development and interaction of the legal and cultural categories food and drug from the late nineteenth century to the present. It is based not only on legal and historical research, but also on theories of category formation from the fields of linguistics and psychology.The scope of the Food and Drug Administration\u27s power is defined primarily by the list of product categories over which it has jurisdiction. The statutory definitions of these categories (food, drug, cosmetic, device, and human biological product) thus delineate the outer boundaries of the arena within which the agency operates. The definitions are also important because the FDA has different degrees of power over different categories of products. The category to which the FDA assigns a product thus largely controls the shape of the regulatory regime the agency will impose on it.The statutory definitions of these product categories are, for the most part, ambiguous and plastic, providing the agency with great regulatory flexibility. But while Congress and the courts have granted the FDA wide discretion, it does not follow that the agency is free to interpret the definitions however it chooses. The effective power of lawmakers to establish legal categories is significantly constrained by preexisting cultural understandings of these categories. Food and drug, the categories whose development and interaction I explore in this article, are not only the oldest defined product classes in federal food and drug law, but also fundamental cultural concepts. I demonstrate that FDA, as well as Congress and the courts, have operated within a constraining cultural matrix that has limited their freedom to impose their preferred understandings of these categories on American society.Nonetheless, my research also provides ample evidence that lawmakers have had substantial power to mold the legal categories of food and drug so as to advance their desired policies. One explanation for this regulatory flexibility in the face of deep-seated cultural conceptions is the indeterminate nature of extralegal notions of food and drug. The terms, as commonly understood, embrace nebulous, overlapping, and constantly evolving realms. Moreover, the relationship between culture and law has not been a one-way street with respect to these categories. Although the regulatory apparatus has always had to take into account the extralegal understandings of food and drug, the law in turn has exerted significant influence over their meaning in broader culture

English is not Enough: The Language of Food and Drug Labels

Food and drug labels must respond to the needs of the increasing linguistic minority population in the United States. Currently, the FDA only requires that food and drug labels be in English. Due to the growing segment of the population that cannot understand English, the FDA is not able to satisfy its goals of communicating valuable information to consumers through food and drug labels. The majority of the non-English speaking population speaks Spanish, suggesting that the FDA must target this specific linguistic minority with any policy response. The paper poses the question of whether the FDA should require food and drug labels in another language in addition to English. The paper is divided into five chapters. The first chapter covers the history of the FDA's approach to food and drug labels. The California Supreme Court's decision in Ramirez v. Plough is analyzed in the second chapter. The third chapter examines the Canadian model of bilingual French/English food and drug labels. Six possible policy options are covered in chapter four. Chapter five, the policy recommendation, concludes that the FDA should ask for comment on a proposal for bilingual English/Spanish warnings and directions on over-the-counter drugs combined with a foreign language patient package insert program for prescription drugs. The paper concludes that a mandate of bilingual over-the-counter drug labels combined with a foreign language patient package insert program is an appropriate and proportionate FDA response to the increasing needs of linguistic minorities

Scientific Opinion on the energy conversion factor of d‐tagatose for labelling purposes

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutritionand Allergies (NDA) was asked to deliver a scienti\ufb01c opinion on the energy conversion factor ofD-tagatose to be used for calculating the energy value of foods to be declared in nutrition labelling.Energy conversion factors for nutrients for the purpose of nutrition labelling have been set based onthe concept of metabolisable energy (ME). The same methodology has been applied to calculate theenergy conversion factor forD-taga tose in this opinion. The assessment is based on a dossier preparedfor Nutrilab NV and submitted by Bioresco Ltd. At present, data are insuf\ufb01cient to derive an accurateME value forD-tagatose. Relying on the human data indicating a mean absorption rate of 80% (range69\u201388%) and a urinary excretion of either 1% or 5%, the corresponding energy values forD-tagatosewould be 2.8 kcal/g (11.8 kJ/g) and 2.96 kcal/g (12.4 kJ/g), respectively. Taking into account that theremaining 20% ofD-tagatose which is not absorbed in the sma ll intestine is fermented in the colonand may deliver at least some energy, e.g. in form of short-chain fatty acids, the Panel concludes thata rounded estimate of the energy conversion factor forD-tagatose based on the available data andcalculated as ME would be 3 kcal/g (12.5 kJ/g). The Panel considers that additional data on theabsorption, distribution, metabolism and excretion ofD-tagatose in humans w ould help in thecalculation of a more accurate energy conversion factor forD-tagatose based on the concept of ME