III. FDA, FDCA & OFPA-Jurisdiction and Authority

A. FDA-Building the regulatory bridge between science & law 43

The Food and Drug Administration (FDA) is a unique organization in that it functions as an interface between food, science, and the law.44 Although the name “Food and Drug Administration” did not appear until 1930,45 the Agency has always sought, among other things, to promote food safety and public health.46 The FDA's Mission Statement reads:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of . . . our nation's food supply . . . . The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. 47

Among its responsibilities, the FDA is entrusted with the duty to ensure that foods are “safe, wholesome, and properly labeled.”48 To accomplish fully the FDA's dual-purpose of promoting food safety and consumer protection, the FDA must focus on the food product rather than the process by which the food is made.49 While consumers may feel a greater sense of protection in knowing how a food was made, the FDA has no authority to require mandatory labeling of the process.50 Rather, the “key factors in determining food safety should be the characteristics of the food itself.”51 Consequently, in its effort to ensure foods consumed by the American public are safe and nutritious, the FDA endeavors to “base regulatory decisions on a strong scientific and analytical base and the law[, and to] understand, conduct and apply excellent science and research.”52 The FDA's policy of basing regulatory decisions upon scientific foundation is key to understanding the FDA's ultimate authority to regulate only the safety of the food product, and not the process by which the food is made.

While there are many historical examples of food safety regulation,53 modern history of food regulation in the United States began in 1862 when President Lincoln established the Bureau of Chemistry within the United States Department of Agriculture.54 At the turn of the twentieth century, the Pure Food and Drug Act (“PFDA”) was passed, “prohibit[ing] interstate commerce in misbranded and adulterated foods, drinks, and drugs.”55 Dr. Harvey W. Wiley, championed as the “Father of the Pure Food and Drugs Act,” is credited for his research into, and response to, the growing concerns of food safety and adulteration within the food industry.56 While the PFDA was a great first step, several defects in the PFDA ultimately led to the enactment of the Federal Food, Drug, and Cosmetic Act57 (“FDCA”) in 1938.58 Although amended multiple times since 1938, the FDCA continues to serve as the most important food regulation law the FDA administers today.59

B. FDCA-Introducing a “materially misleading” requirement for misbranded food items

The primary purpose of the FDCA is to protect the health and safety of the consuming public.60 The enactment of the FDCA gave the FDA authority to regulate better the placement of “adulterated” and “misbranded” food products in the stream of interstate commerce.61 The term “food” is defined to include any “articles used for food or drink for man or other animals.”62 Generally, a food is considered “adulterated” if it is unsafe, harmful, poisonous, or is in any way “injurious to health.”63 “Misbranded” foods are falsely or misleadingly labeled.64

One of the most significant ways the FDA regulates food and drugs is by supervising product labeling.65 The FDCA prohibits, among other things, manufacture, introduction into interstate commerce, or receipt of any misbranded or adulterated food products.66 Penalties for violations include injunctions,67 fines,68 imprisonment,69 and seizure.70

The vast majority of the FDCA's labeling requirements deal with information regarding the food product's identity, manufacturer, quantity, ingredients, and nutritional value.71 However, a general prohibition against misbranded foods remains.72 The definition section of the FDCA provides additional insight as to what is considered false and misleading, stating:

If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the articles to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. 73

Thus, a materiality standard is present in determining whether a label is false or misleading.74 Based on this definition, the materiality standard applies both to information affirmatively stated and to omitted information that is relevant in light of the other information provided.75 Rather than focusing on the hypothetical material value, the FDA has been more pragmatic, generally focusing on the characteristics of the food itself.76 Thus, in order to determine the FDA's regulatory jurisdiction, one must ask whether the fact that beef is cloned is material within the FDA's definition.

C. OFPA-Regulating “Organic” Labels by Process, not Product

In contrast to the authority granted to the FDA and the FDCA, Congress granted to the United States Department of Agriculture (USDA), under the Organic Foods Production Act of 199077 (“OFPA”), the authority to regulate the process by which organic foods are grown.78 As the statute illustrates, the purpose of the OFPA is “to establish national standards governing the marketing of certain agricultural products as organically produced products [and] to assure consumers that organically produced products meet a consistent standard . . . .”79 Thus, the OFPA is concerned with the process by which organic foods are created and not the qualities of the food product itself.80

“Organic foods” are generally thought to include foods grown without the use of conventional pesticides, herbicides, or fertilizer.81 Farmers use environmentally friendly techniques for growing organic foods, including “the use of renewable resources and the conservation of soil and water.”82 In regards to animal products, livestock must be raised on an organic farm, consuming only organic foods, and producers “shall not use growth promoters and hormones on such livestock, whether implanted, ingested, or injected . . . .”83 Using the label “organic” on a food product subsequently has the effect of assuring the consumer that a food was produced and handled in a particular way; “organic” is a process claim.84 Moreover, the label “organic” does not address the safety or the nutritional value of a food product; “organic” is not a product claim.85

The National Organic Program (“NOP”), a program established under the Agricultural Market Service branch of the USDA,86 has developed regulations to “ensure that organically labeled products meet consistent national standards.”87 Using the standards set forth by Congress in the OFPA, the NOP established rules defining what is considered “organic,” establishing organic production and handling requirements, permitting voluntary labeling of organic foods, and explaining certification and accreditation of certifying agents.88 In addition to signifying that a food was not produced using synthetic pesticides, herbicides and fertilizers, an “organic” label also means that it was not produced or handled using “excluded methods.”89 Excluded methods include:

A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. 90

Of particular importance to this Comment are whether meat and dairy products resulting from the cloning process could be considered an organic food, and whether the definition of “excluded methods” would include cloned food products.