Labeling rDNA Biotechnology-Derived Foods:

Labeling requirements that apply to foods in general also apply to foods produced using rDNA biotechnology. Generally speaking, the Food and Drug Administration (FDA) has authority over food labeling, and the Federal Trade Commission (FTC) has authority over food advertising. The federal law governing labeling of foods, excluding meat and poultry, is the Federal Food Drug and Cosmetic Act (FFDCA). Under this statute, the FDA regulates food labeling through a series of requirements that are intended to assure that the information of significance about a food product is provided and that the food labeling is truthful and non-misleading.

Labeling Defined

Labeling is defined by the FFDCA as “written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Thus, labeling includes but is not limited to the label that is physically attached to the immediate container of foods in package form. Physical attachment or proximity of the material to the product is not required for the material to be considered labeling.

Certain information is required on the labels of almost all foods. This includes the common or usual name of the food; a net contents statement; an ingredient listing for products made from more than one ingredient; the name and place of business of the manufacturer, packer, or distributor; and nutrition labeling.

Beyond these fundamental label requirements, the food processor is generally at liberty to make use of the label or labeling space in the manner it deems fit, provided that the label or labeling is not false or misleading.

Truthful, Not Misleading

If a statement, picture, or other representation on the label or labeling of any food product is false or misleading, the food is misbranded regardless of the importance of the representation to the consumer. The Supreme Court has held that it is not necessary to show that anyone was actually misled or deceived, or that there was any intent to deceive, in order to find that a product is misbranded under the FFDCA. Other courts have stated that the test is not the effect of the label on a “reasonable consumer,” but on “the ignorant, the unthinking, and the credulous” consumer.

The prohibition on misleading labeling statements reaches far beyond patently false claims. Statements that are false by virtue of what they imply about counterpart food products are also prohibited as misleading. FFDCA explicitly prohibits a claim that states the absence of a nutrient unless the nutrient is usually present in the food. For example, “cholesterol-free broccoli” falsely suggests that ordinary broccoli contains cholesterol. Thus, the claim is misleading because ordinary broccoli does not have cholesterol. Alternatively, the claim “broccoli, a cholesterol-free food” would be considered truthful and not misleading.

Just as labeling statements may be misleading because of what they say or imply, they may be misleading by virtue of what they do not say. In determining whether a food labeling statement is misleading, the FDA and the courts take into account the extent to which the labeling fails to reveal any material facts. What constitutes a material fact remains undefined and therefore must be evaluated on a case-by-case basis. Generally, if a food is significantly different from its conventional counterpart in composition, nutritional value, or safety, the difference in the food would be considered a material fact. For example, if a new processing technique resulted in a significant decrease in the nutrient content or change in the flavor, color, or other valued characteristic of a food, a label statement would be required to inform consumers of that material fact. Absent a label statement disclosing a material fact about a food, the presentation of the food would be misleading. So, the FFDCA prohibition on false or misleading labeling may effectively require that a label bear a disclosure of the material fact.

While some FDA disclosure requirements are imposed to provide for safe use of food ingredients, or to provide consumer warnings, many disclosure requirements are imposed to clarify or explain an otherwise misleading label statement. For example, FDA decided that a statement of the percent reduction is necessary to clarify a claim like “reduced fat.”

Labeling in Special Cases

In evaluating the labeling framework for rDNA biotechnology- derived foods, consideration should be given to at least three analogous situations: irradiated foods, milk from rBST treated cows, and organic foods.

Food Irradiation. Irradiation entails the treatment of a food with an FDA-approved energy source that kills bacteria or pests, prevents sprouting of root vegetables, or extends shelf life in some foods. Irradiation is a process that triggers a label disclosure requirement because FDA determined that irradiation can render food materially different, in that it can alter the taste, smell, or texture— although the scientific information available today might support a different agency conclusion. Nonetheless, FDA has determined by regulation that the fact that a food is irradiated is material, justifying the labeling requirement of a logo and a phrase such as “treated with radiation.” The irradiation label disclosure requirements have been cited as at least one of the major reasons inhibiting the use of the technology.

Recombinant Bovine Somatotropin. In the early 1990s, FDA approved treatment of dairy cows with recombinant bovine somatotropin (rBST), an rDNA biotechnologyderived version of a naturally occurring hormone that increases a cow’s milk production. FDA determined that milk produced by cows treated with rBST was not significantly different from conventional milk. Like biotechnology, significant controversy accompanied the introduction of rBST into the marketplace. Some manufacturers attempted to address consumer interest in avoiding milk from rBST-treated cows by labeling milk products as “rBST-free.” FDA discouraged “rBST-free” claims because they implied that there is some compositional difference, such as the presence of rBST, between milk from treated and untreated cows. Rather, FDA encouraged the use of claims that address the production procedure rather than the product. So, FDA announced that an appropriate way to phrase such a claim would be, “from cows not treated with rBST,” as long as the statement also provided a context that did not imply a difference between the milks. FDA’s example was to include with the claim, “No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows.”

The state of Vermont enacted a law requiring that milk from cows treated with rBST bear a mandatory label disclosure. Without a material fact that distinguishes the characteristics of milk from rBST-treated cows from other milk, however, the U.S. Court of Appeals for the Second Circuit declared Vermont’s disclosure requirement unconstitutional.

Organic Foods. The term “organic foods” has been used to describe foods grown by farmers committed to reduced chemical use, a healthier environment, more humane treatment of animals, greater worker safety, and enhanced food safety. To date, however, evidence does not demonstrate that organic foods have superior nutritional or food safety benefits over non-organic foods. Therefore, FDA has deemed some claims on organic foods misleading when the term “organic” has been used in a manner that implied the organic food is somehow superior to a similar non-organic food.

The Organic Food Production Act (OFPA) of 1990 required the U.S. Department of Agriculture (USDA) to develop national organic standards and establish an organic certification program based on recommendations from an expert panel. On March 13, 2000, USDA announced its National Organic Program (NOP), a comprehensive proposed rule that would set uniform national standards. USDA’s goal is to issue a final NOP rule by the end of 2000.

The NOP would create three categories of permissible label claims, each with its own criteria: (1) 100 percent organic; (2) organic; and (3) made with organic specified ingredients. Products labeled “100 percent organic” would have to be all organic product; products bearing the “organic” label would have to contain not less than 95% organically produced product; and products labeled “made with organic (specified ingredients)” would have to contain at least 50% organic ingredients.

Under the proposed rule, rDNA biotechnology-derived and irradiated foods are not considered “organic.” Any product made with what the proposed rule terms “excluded methods” (which include the use of rDNA biotechnology) could not be labeled as “organic.” Thus, it may be possible for consumers wishing to avoid rDNA biotechnology- derived foods to purchase foods bearing one of the three “organic” label claims on the principal display panel.

U.S. Labeling Policies for rDNA Biotechnology-Derived Foods

Mandatory Disclosures. FDA requires labeling of rDNA biotechnology-derived foods that differ significantly in composition, nutritional value, or safety from their conventional counterparts. If a safety or usage issue exists for the new food, a statement must be made on the label to describe the issue. For example, if a food produced using rDNA biotechnology has significantly different nutritional properties, its name must reflect the difference (e.g., “high oil corn”). Likewise, if a new food includes an allergen that consumers would not expect based on the name of the food, such as the hypothetical use of a peanut protein in a tomato, the presence of that allergen must be stated on the label.

Some have advocated that the mandatory labeling requirements reach beyond disclosure of material facts regarding the food. They have urged a blanket requirement for disclosure when a food is derived using rDNA biotechnology. FDA considered public comments and all available scientific evidence in connection with a possible blanket rDNA biotechnology disclosure requirement. FDA rejected such a blanket requirement because it was “not aware of any information showing that [rDNA biotechnology-derived foods] differ from other foods in any meaningful or uniform way, or present any different or greater safety concern than foods developed by traditional plant breeding.”

In the absence of a material fact to distinguish an rDNA biotechnology-derived food from its conventional counterpart, the imposition of a blanket disclosure requirement would be constitutionally suspect. As with the Vermont rBST label disclosure requirement that was ruled unconstitutional, the absence of a distinguishing characteristic of the rDNA biotechnology-derived food requires the government to demonstrate a substantial government interest to justify a label disclosure requirement. “Consumer curiosity” alone, the court ruled, is insufficient.

Voluntary Claims. Foods that are not rDNA biotechnology- derived may be labeled as such in a truthful and nonmisleading manner. A processor asserting that a product includes no rDNA biotechnology-derived ingredients must be able to substantiate that claim to provide reasonable assurance of its accuracy. Before a processor undertakes that risk, it may consult with FDA on potential options for substantiating the claim. The answer may have significant economic effects that can greatly influence the availability of such claims.

Methods of substantiation can vary in reliability and cost. For example, supplier certifications are generally regarded as less accurate and less expensive than product testing. FDA would seek accuracy, but be reluctant to require an excessively expensive substantiation method since its costs could discourage the undertaking.

The degree of purity is a complex issue that must be resolved with careful consideration of what such a claim is likely to mean to the consumer. For example, a claim like “These ingredients were not genetically modified,” which addressed the process by which the food was produced, would not imply the same degree of purity as a “Free of GM ingredients” claim.

Processors making voluntary claims would also need to be mindful of the potential of such a claim to inaccurately imply superiority of the food over its conventional counterpart, and, as in claims of rBST-free, to be deemed misleading. As with organic foods, clear guidance as to the government’s expectations regarding voluntary claims can eliminate the regulatory uncertainty that may discourage investment in a new product line of foods that are to be marketed as free of rDNA biotechnology-derived ingredients.

Some voluntary claims regarding rDNA biotechnologyderived foods are not claims that the food is free of rDNA biotechnology-derived ingredients. One of the first rDNA biotechnology-derived foods introduced to the market was the FlavrSavrTM tomato, which bore a voluntary claim indicating that the tomato was developed through rDNA biotechnology. The issues regarding such claims are far more straightforward. As discussed above, these claims also must be truthful and non-misleading.

Food Labeling and the First Amendment

All food labeling requirements must satisfy requirements of the U.S Constitution.

The First Amendment of the Constitution states that “Congress shall make no law ... abridging the freedom of speech.” Commercial speech, which includes food labeling, is protected under the First Amendment, but can be subject to more stringent government regulation than other kinds of speech, such as political commentary. The government may restrict commercial speech:

• If the speech is either misleading or concerns an unlawful activity;

• If the asserted governmental interest in support of the restriction is substantial;

• If the restriction directly advances the government’s substantial interest; and

• If the regulation is not more extensive than is necessary to serve that interest.

The First Amendment protects the right not only to speak, but also the right not to speak. The constitutionally protected right not to speak is called the compelled speech doctrine. While no commercial compelled speech doctrine has been articulated, the Supreme Court has suggested that compelling someone to speak voluntarily is an even more serious constitutional matter than preventing speech. Such constitutional considerations may come into play in the debate over labeling and rDNA biotechnology.

--- PAGE BREAK ---

International Policies

The regulation of rDNA biotechnology-derived foods differs widely in other countries. Some countries do not allow them to be imported at all, on the basis that not enough is known about the long-term effects of consuming rDNA biotechnology-derived foods. Other countries permit such foods, with requirements that each food disclose on the label that it was produced using rDNA biotechnology. Such policies require foods at each stage of production, from raw agricultural product to finished consumer package, to bear a statement like “Contains GMO.” Still other countries, like the United States, compare the new plant variety to varieties produced using conventional breeding to identify differences for safety evaluation and to determine whether the differences need to be described on the food label. These countries do not require statements that the food was derived using rDNA biotechnology.

Codex Alimentarius Commission. The primary international forum for discussion of labeling of biotechnology- derived foods is the Codex Alimentarius Commission (Codex). The Codex Committee on Food Labelling (CCFL) has been discussing how rDNA biotechnology-derived foods should be labeled for several years. The goal is to have a single approach to labeling requirements.

Two basic approaches to labeling are being considered by the CCFL. One, based on the principle of comparing new varieties of foods to those produced by conventional means, would require the description of any differences on the label. That is, where the rDNA biotechnology-derived food differs significantly from the conventional version of the food in nutritional value, in physical or handling properties, or by the presence of an allergen not indicated by the name of the food, this difference would have to be disclosed on the label.

The other approach to labeling involves the conclusion that the use of rDNA biotechnology, either in the food or to produce the food, is itself a difference that requires disclosure. The United States, Canada, and several other countries support the approach that only the differences need to be disclosed, while the European countries and others favor what is called the “mandatory labeling” approach. A number of countries are currently developing national policies, and several of them are likely to require mandatory labeling.

The European Union (EU), Japan, South Korea, Australia, and New Zealand have all passed, or are considering, laws requiring that food containing rDNA biotechnologyderived ingredients be labeled. Any labeling program would need to include a level of inadvertent rDNA biotechnology-derived crop contamination above which labeling would be required. There is currently no consensus on what such a regulatory level should be.

Several agencies in Europe and the United States, including the European Commission’s Joint Research Centre, the U.S. National Institute of Standards and Technology, and USDA’s Grain Inspection, Packers, and Stockyards Administration, are working on reference standards and validation programs for rDNA testing methods. Validation and standardization of sampling and testing methods are essential to resolving disputes regarding the status of food ingredients, and for regulatory authorities responsible for enforcing mandatory labeling laws.

Cartagena Protocol on Biosafety. While Codex is the major forum for discussion of international food labeling requirements, more than 130 countries adopted the Cartagena Protocol on Biosafety at the Convention on Biodiversity (CBD) in January 2000. The protocol calls for “living modified organisms” (LMO) intended for “food, feed, or processing” to be identified as LMO. According to the U.S. Department of State, the protocol requires international shipments of bulk LMO commodities to be accompanied by documentation stating “May contain LMOs” but does not impose a consumer product labeling requirement. The protocol awaits ratification by the U.S. Senate and therefore has no legal effect in the United States at this time.

Impact of Market Segmentation for Biotechnology-Derived Crops

Labeling of rDNA biotechnology-derived foods, whether mandatory or voluntary, must be premised on discrete distribution channels for the underlying commodities, such as soybeans and corn. The world markets for corn and soybeans are already undergoing a process of segmentation in response to concerns in the EU and elsewhere. There are three methods to verify the segregation of non-rDNA biotechnology-derived foods: final product testing, producer validation and market segregation, and third-party certification. Each has its advantages and limitations, but all come with an economic cost.

Final Product Testing. This approach provides assurance that the sample selected for testing meets the standards of the buyer. It focuses on the attributes of the product rather than on the process by which it was produced and delivered. The disadvantages are the costs and uncertainties of sampling and testing. Current sampling methods provide a low level of confidence that a large bulk shipment is adequately represented by the sample analyzed.

Producer Validation and Market Segregation. In this strategy, the producer validates that the plants were not developed using rDNA techniques. If the product is shipped in small containers dedicated to non-biotechnology-derived grain, guaranteeing the process will also address the final product. Although producers may know the variety and the extent of potential cross-pollination at the time of harvest, much commercial grain is delivered by commercial haulers who do not have this information. Without prior contracts or arrangements with the producer, producer validation and affidavits have questionable reliability.

This strategy also requires grain handling establishments to maintain separate facilities, as it is not feasible to clean facilities of all rDNA biotechnology-derived grain between loads. Some establishments designate one of their facilities for handling non-rDNA biotechnology-derived grain, thus simplifying the problem of identification at the time of delivery. Yet a major obstacle to maintaining purity through the rest of the market channel still exists, because trucks, rail cars, barges, and port equipment must also use dedicated equipment to guarantee that all biotechnologyderived grain has been excluded.

Third-party Certification. This strategy is based on the premise that it is more effective to guarantee the process than to guarantee the product. No shipper can assure that a very small amount of biotechnology-derived product will not be introduced into a shipment from any of many sources, including the storage facility in the destination country. Instead of guaranteeing 100 percent purity, this approach provides assurances that the grain has been handled in such a way as to minimize the possibility of contamination.

Consumer Opinion

Labels are a valuable source of information for consumers. Some surveys indicate that the majority of consumers want foods derived by rDNA biotechnology to be labeled; however, consumers frequently respond affirmatively when asked if they want additional information. In 1993, Thomas J. Hoban of North Carolina State University and Patricia Kendall of Colorado State University conducted a survey of consumer perspectives on labeling. When asked if labels should contain a variety of information, 85 percent of consumers desired disclosure that rDNA biotechnology was used. Fewer consumers expressed interest in labeling if rDNA biotechnology was used to produce ingredients or processing aids, such as chymosin for cheese making. Other information, such as use of pesticides or country of production, was desired by 94 percent and 80 percent, respectively.

In a 2000 survey by the Wirthlin Group, FDA labeling policy was explained as follows: “The U.S. Food and Drug Administration requires special labeling when a food is produced under certain conditions: when rDNA biotechnology’s use introduces an allergen or when it substantially changes the food’s nutritional content, like vitamins or fat, or its composition. Otherwise special labeling is not required.” The majority of consumers supported the policy, with 42 percent indicating strong support; and 28 percent opposed the policy, with 18 percent strongly opposed. When presented with an alternative view, that all rDNA biotechnology-derived products should be labeled, 52 percent continued to support FDA’s policy, 43 percent supported labeling all products, and 5 percent did not know. General consumer research has shown that label statements should be clear and not misleading and should provide salient facts to the consumer. Consumers indicated that labeling should be in laymen’s terms, use consistent terminology, and follow a standard format.


The IFT Labeling Panel concludes that the following facts are fundamental to resolving issues regarding the labeling of rDNA biotechnology-derived foods in the United States:

  • Within the constitutional framework, the FFDCA provides for a food labeling regulatory regime that is intended to ensure that information about food products is presented to consumers in a truthful, non-misleading manner. This regulatory system requires disclosure of any significant difference in the characteristics of an rDNA biotechnology-derived food when compared with its conventional counterpart. In addition, voluntary label statements must be substantiated and not misleading, either overtly, by implication, or by omission.
  • Mandatory label disclosure requirements may not reach beyond addressing material facts about a food. If rDNA biotechnology were used in the development of a plant variety but the rDNA biotechnology-derived food was not significantly different from the conventional counterpart, there would be no material fact regarding the food to disclose. Thus, absent significant differences, the fact that a food is rDNA biotechnology-derived is not by itself a material fact.
  • Voluntary labeling has been used to establish markets for niche categories of foods desired by consumers.
  • Any labeling requirements or policies to distinguish rDNA biotechnology-derived foods from other foods would require definitions and monitoring tools sufficiently precise to meet the objectives of the requirement or policy.
  • Labeling initiatives for rDNA biotechnology-derived foods are likely to have substantial effects on the production, distribution, and cost of food to consumers.
  • If a voluntary labeling initiative to distinguish rDNA biotechnology-derived foods is pursued, broad stakeholder agreement should be achieved regarding appropriate substantiation of claims.
  • Terminology used in labeling should convey information to the public in an understandable, accurate, and non-misleading manner.

In an effort to contribute to a meaningful dialogue on scientific issues and consumer concerns about rDNA biotechnology, the Institute of Food Technologists, a non-profit society for food science and technology, conducted a comprehensive review of biotechnology. IFT convened three panels of experts, consisting of IFT members and other prominent biotechnology authorities, to evaluate the scientific evidence and write a report divided into four sections: Introduction, Safety, Labeling, and Benefits and Concerns.