VI. Analysis

A. Regulatory Interpretation

If meat or dairy products from cloned cattle fall under the definition of either “misbranded” or “adulterated,” the FDA would be able to regulate these products, perhaps insisting upon a labeling requirement. The FDCA would consider a food to be misbranded if the labeling was false or misleading in any manner.185 This raises a question of whether a 16-ounce rib-eye steak not labeled as originating from a cloned cow would be considered misbranded on the grounds that the label is false or misleading. Given how the FDCA defines what is misleading, an inquiry into materiality is required to determine whether a label is misleading.186 This raises another question: what is considered material?

In the Federal Register, the FDA made two comments that appear to address this question; however, the two statements seem to be in conflict with one another. The first statement, that “[h]istorically, [the] FDA has generally limited the scope of the materiality concept in section [321(n)] of the [FDCA] to information about the attributes of the food itself,”187 implies that a label would be misleading if the cloned food product itself was materially different from a non-cloned food product. However, the second comment complicates this analysis. The FDA also commented that it generally sought to determine materiality on the basis of “whether consumers view such information as important and whether the omission of label information may mislead a customer.”188 Under this reading of the materiality standard, a food label could be misleading from the viewpoint of a purchaser. However, because the consuming public is generally uninformed about animal biotechnology and the safety of cloned food products, the “consumer interest alone [should] not [be] enough to justify requiring [what] information [should be] included in food labels.”189 Since the FDA's authority to regulate food is based on the safety of the food product itself, a standard based on scientific evidence about the food would be more reliable.190 Therefore, if a food product derived from a cloned cow is “materially” different, meaning the FDA determined that the food qualities are significantly unlike those of non-cloned beef, the FDA could regulate the distribution throughout the market and insist upon a labeling requirement. On the other hand, if meat from a cloned animal is not “materially” different from non-cloned beef, the food product is outside of the FDA's authority to impose a mandatory labeling requirement alerting consumers to this fact.

The materiality element was addressed by the FDA in the DRA, which analyzed vast amounts of data from published reports on the potential risks that cloning may have on animal and human health.191 The FDA concluded there was no increased risk associated with consumption of cloned beef-“[A]nalysis of the composition of meat . . . and milk from bovine clones consistently indicates that there is no biologically relevant difference between the composition of food from clones . . . [and] food commonly consumed from these species on a daily basis.”192 Preliminary evidence shows there is no significant difference in the quality of the meat, whether it is from a cloned cow or from a cow bred by some other technique.193 According to the available data, the fact that the meat comes from a cloned cow, or its offspring, is immaterial for the purposes of misleading labels.194 While the possibility remains that future scientific experiments may find that cloned beef is not safe for human consumption, currently there is no evidence that cloned meat satisfies the materiality test of the FDCA. Therefore, a mandatory labeling requirement for cloned beef is not warranted.

Instead of a mandatory labeling requirement for cloned beef, suppose producers of non-cloned beef choose to voluntarily label their products as, for example, “clone-free,” “non-cloned,” or “from cows not produced using cloning technology.” Assuming the surveys are true that over 60% of the population would not purchase food products from cloned animals, consumers might be receptive to producers voluntarily labeling their products as “non-cloned.”195 While such a label might provide truthful, non-deceptive information to the consumer, the voluntary label could mislead the consumer by suggesting that the non-cloned food possesses superior qualities as compared to the cloned food.196 Just as in the context of the bovine growth hormone197 or genetically modified foods,198 voluntarily labeling a food product as “non-cloned” would misleadingly imply that non-cloned beef was safer or of better quality than cloned beef and that cloning “adversely affects the character, quality, or nature of the food.”199 Thus, a “non-cloned” voluntary label would be materially misleading and misbranded under the FDCA and cannot be used by producers desiring to meet consumers' concerns and desires regarding cloned beef.

It should be reiterated that the DRA was peer-reviewed for accuracy and the FDA reached this conclusion only after reviewing scientific data from hundreds of experiments and reports.200 For example, the FDA relied on the study conducted by the University of Connecticut in conjunction with the Kagoshima Prefectural Cattle Breeding Development Institute in Japan.201 The study found strong evidence to support the conclusion that meat and milk from cloned cattle is safe for human consumption and that there were no significant differences in quality as compared to the comparator cows.202 As to the cloned milk experiment, over 1,000 samples were tested according to monitoring parameters commonly used in the dairy industry.203 No significant difference in the milk composition was found.204 The study also compared the quality of cloned meat as compared to non-cloned meat using over 100 different parameters.205 The results indicated that “no significant difference was detected in [over] 90% of all parameters examined,” and the variance in the remaining ten percent was not of public concern.206

From a jurisdictional perspective, the FDA is not the proper forum to bring non-scientific concerns about cloned food products. It is important to remember that the FDA's analysis in the DRA is limited to the scientific evidence about the safety of the food product, and that “consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement . . . .”207 The FDA's mission is to “base regulatory decisions on a strong scientific and analytical base and the law; and understand, conduct and apply excellent science and research.”208 Currently, the scientific evidence shows that cloned beef is not materially different from non-cloned beef. If the public ultimately shows a preference for having cloned foods labeled, the food industry may choose to self-regulate in order to avoid alienating consumers.209 Nevertheless, producers cannot voluntarily label non-cloned beef as such on account of the misleading nature of such a label. Along the same lines, consumers would be better served going to Congress and requesting a change in the U.S. food labeling policy.210 However, in recognition of all of the concerns, the FDA does propose to continue to evaluate the scientific evidence, to support dialogue, and to educate the public so that these fears and concerns may either be abated or addressed in some other fashion.211

B. Analogy to Genetically Modified Foods

Assuming the decision not to require mandatory labeling for genetically modified foods is correct, one can draw an analogy between genetically modified foods and cloned beef and conclude that the lack of a U.S. labeling requirement for genetically modified foods can serve as a basis for not implementing a labeling requirement for cloned beef. Both are technological advancements designed to increase the quality of the food product delivered to the consumer by enhancing the traits of the underlying organism, whether it be plant or animal. Whereas genetically modified foods involve manipulating and altering the genetic code of plants, cloning involves copying the genetic code in an effort to reproduce the desired characteristics of the parent animal.

Critics of genetically modified foods argue that the U.S. should join the international community by adopting a mandatory labeling requirement for genetically modified foods, such as the European Union's (EU) regulation.212 The EU's position is that any future harmful effects of genetically modified foods, and cloned meat for that matter, are currently unknown. To protect the health of both humans and animals adequately, such foods should be labeled so as to give people the right to choose for themselves.213 The regulation of genetically modified food in the EU is focused on the process of how the food is made, while the United States focuses on the safety of the food product itself. Therefore, in the U.S., the need for genetically modified foods to be labeled as such follows the same materiality analysis under section 321(n) of the FDCA. Except for differences in nutrition or allergens, there were no data or evidence to suggest that genetically modified foods were significantly different from, or lead to any greater safety risk than, other naturally grown foods.214 Based on the FDA's regulatory authority, the fact that a food had been genetically modified was not material and did not necessitate label requirements.215 Likewise, since the FDA found there were no significant differences in health risks between the consumption of either cloned beef or meat from conventionally bred animals, the fact that a cut of meat comes from a cloned cow is not material and, thus, does not necessitate labeling requirements. If the foods are not materially different, a label is not misleading if it fails to state that the meat comes from a cloned animal. Therefore, the FDA has no authority to require such a label.

While the FDA's authority under the FDCA does not require mandatory labeling requirements for cloned beef, wary consumers may find that they can avoid purchasing cloned beef if they so choose. Just as with genetically modified foods, consumers may soon nonetheless know they are not buying cloned beef when they purchase organic foods. According to current regulations, “excluded methods” does not include cloning techniques as a form of genetic modification.216 Additionally, in order to be labeled “organic,” livestock must remain under continuous organic management,217 which includes “a total feed ration composed of agricultural products . . . that are organically produced . . . , and the producer of an organic operation must not use animal drugs, including hormones, to promote growth.”218 These regulations do not appear to exclude cloned beef from potential organic labeling. However, soon after the FDA released the DRA, the National Organic Program (“NOP”) released an announcement clarifying its position “regarding cloning and animals produced using cloning technology for organic livestock production.”219 The NOP ultimately concludes that cloned beef cannot be labeled “organic.”220 Concurring with the NOP's conclusion, the National Organic Standards Board goes one step further and recommends that the “excluded methods” regulation be amended to include cloning as follows:

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. Some methods include cell fusion, microencapsulation and macroencapsulation, somatic cell nuclear transfer (or other methods of animal cloning) , and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the position of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, artificial insemination , conjunction, fermentation, hybridization, in vitro fertilization, or tissue culture. 221

Thus, after these amendments are made, a consumer can be assured of consuming non-cloned beef when he or she purchases “organic beef.” As with genetically modified foods, organic food labeling becomes the next best alternative to mandatory labeling of cloned beef.