Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852


Re:     Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (Docket No. 00D-1598)

Dear Sir or Madam,

The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration’s (FDA’s) request for comments on the agency’s draft guidance document entitled, “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering” (hereinafter Draft Guidance). See 66 Fed. Reg. 4839 (Jan. 18, 2001). As a signatory to a citizen’s petition submitted to the Agency last May, which asked FDA to establish voluntary labeling guidelines for claims related to food biotechnology, FMI strongly supports FDA’s decision to issue a guidance document explaining the lawful claims that may be made regarding the use or omission of biotechnology in the manufacture of food products. Once finalized, the Draft Guidance will assist food manufacturers and, more importantly, benefit consumers, both as a source of information and as a mechanism for achieving a consistent standard for labeling and claims throughout the marketplace.

     A.     Executive Summary

FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI’s domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $300 billion, which accounts for more than three-quarters of all grocery sales in the United States. FMI’s retail membership is composed of large multi-store chains, small regional firms, and independent supermarkets. Our international membership includes 200 members from 60 countries.

FMI and its members have a longstanding commitment to ensuring that consumers are offered high quality food and that consumers have confidence in the safety of the food that they purchase. We value the opportunity to work closely with FDA on important food safety issues such as the Partnership for Food Safety Education and the consumer brochure on irradiation.

With respect to biotechnology, FMI’s Board of Directors adopted a policy statement on bioengineered food on October 16, 1999. (copy enclosed) Our policy statement recommends that FDA establish guidelines for claims regarding biotechnology and food production. A copy of the statement, which was also adopted by the Grocery Manufacturers of America, was sent to FDA in advance of the Agency’s December 1999 hearings. FMI also developed a brochure for grocery stores to distribute to consumers to provide objective information on bioengineered foods. (copy enclosed) In light of FDA’s leadership role on this issue, our brochure cites the Agency’s website as a good source of information for consumers. We also responded to FDA’s request for comments on the Agency’s current policy and joined in a petition with other food industry trade associations asking FDA to develop food biotechnology labeling guidance.

Given our support for FDA’s development of voluntary labeling guidelines, both in our policy statement and in the citizens petition, FMI applauds the Agency for issuing a Draft Guidance on voluntary claims. Although our specific comments are discussed more fully below, we particularly wanted to call your attention to two issues.

First, we support FDA’s decision not to require a quality disclaimer on foods labeled that they were not produced through biotechnology. Specifically, FDA provided no evidence that a claim that biotechnology was not used in the production of a food product is inherently an unlawful implied superiority claim that must be cured with a disclaimer. Moreover, a consumer’s view of the relative value of different production methods with respect to the ultimate food product or its ingredients is based on the individual’s subjective values. Although, as FDA notes, the absence of biotechnology may not make the product safer or “of higher quality” in an absolute sense, people that hold certain moral or religious beliefs may prefer foods produced without biotechnology, in the same way, for example, that foods produced in accordance with Kosher law are preferred by some religious adherents or that organic foods are preferable to others. Neither foods labeled as Kosher nor organic are required to carry a disclaimer regarding their relative value to foods produced through conventional processing techniques. Similarly, FDA should not require foods that are labeled with lawful claims that biotechnology was not used in their production to bear a disclaimer.

Second, we urge FDA to amend the section on substantiation of claims to add information on the substantiation necessary for claims regarding the use or presence of bioengineering in the production of food. As currently written, the section only addresses substantiation for claims regarding the absence of biotechnology.

     B.     Legal Background

Section 403 of the FD&C Act sets forth the statutory standards and requirements for food labels and labeling. 21 U.S.C. § 343. In relevant part, food will be deemed misbranded if its label fails to bear information specified in the statute or if the labeling is false or misleading in any particular. In determining whether labeling is misleading, the statute directs the Agency to consider whether any facts that are material either in light of other representations made about the product or with respect to consequences that may result from the use of the product have been omitted. 21 U.S.C. § 321(n); see also, 21 C.F.R. § 1.21. FDA has interpreted information to be “material” within the meaning of the statutory standard if the absence of the information might pose a health risk or if its absence might mislead consumers about the food based on other contextual factors, such as other labeling statements or the food’s similarity to other foods. Draft Guidance at 2.

In 1992, FDA issued a notice entitled, “Statement of Policy: Foods Derived from New Plant Varieties” (hereinafter “1992 Policy Statement”), in which the Agency interpreted the foregoing legal requirements with respect to labeling for foods produced through biotechnology. 57 Fed. Reg. 22984 (May 29, 1992).   At the time, FDA found that it had no basis to conclude that bioengineered foods “differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.” 57 Fed. Reg. at 22991. Accordingly, the Agency declined to require foods produced through biotechnology to be labeled as such. The current Draft Guidance reaffirms the Agency’s decision not to require special labeling of all bioengineered foods because the Agency “is still not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact” that requires disclosure under the FD&C Act. Draft Guidance at 3.

The 1992 Policy Statement did, however, set forth circumstances under which bioengineered food would be required to bear a label containing specific information about the finished food product. For example, labeling will be required if a food derived from a new plant variety differs from its traditional counterpart such that the common or usual name no longer applies or if a safety or usage issue exists to which consumers must be alerted. 57 Fed. Reg. at 22991. The examples chosen to illustrate the policy are the presence of an unexpected allergen or a nutrient profile that differs from the food’s traditional counterparts. In these situations, the labeling would be required to advise consumers of the allergen or the change in nutrients, but would not be required to specify that the food was produced via biotechnology. The Draft Guidance confirms the statutory interpretations set forth in the 1992 Policy Statement and adds to them guidance to assist manufacturers who wish to label their foods as being made with or without the use of bioengineered ingredients on a voluntary basis. The Draft Guidance was developed in part based on the results of four focus groups conducted by FDA and documented in the Agency’s “Report on Consumer Focus Groups on Biotechnology (October 20, 2000) (hereinafter Focus Group Report).


     C.     Comments on Draft Guidance

FMI’s policy statement supports the consumers’ basic right to know the relevant information about the products that they buy. In this regard, FMI supports the use of labeling that will provide descriptive information to consumers that they can use. Clearly, the presence of an unexpected allergen or a significant difference in composition is relevant information about which consumers must be advised and such disclosure is required by FDA’s interpretation of the FD&C Act. We support FDA’s policy in this regard.

Furthermore, we agree with the general approach underlying FDA’s Draft Guidance, which favors informative labeling or claims. Although statements beyond the disclosures required in accordance with the 1992 Policy Statement cannot be required, by providing examples and explaining the circumstances under which additional claims are lawful, FDA has paved the way to allow manufacturers to provide more useful information to consumers.

We should also note that the discussion in the Focus Group Report regarding participants’ responses to claims regarding the use of biotechnology supports our policy statement’s recommendation that FDA engage in further consumer education. Specifically, the Report indicates that, as participants considered the various examples of bioengineered foods, they began to see the value of having more information than mere disclosure of whether products are produced by food biotechnology. Focus Group Report at 5. Accordingly, as set forth in our policy statement, we continue to recommend that the Agency engage in activities to educate consumers further on this issue. As further provided in our policy statement, common understanding of elements as basic as the nomenclature (such as FDA’s carefully developed distinction between “genetic modification” and “biotechnology”) would greatly help consumers and facilitate reasoned discussion of the issue.

     1.     Statements about foods developed using bioengineering

FDA’s Draft Guidance includes discussion and examples of permissible claims that may be used to inform consumers that biotechnology was used to produce a food or the ingredients used in the food. Draft Guidance at 4-5. In general, the examples provided tend to be informative in nature; that is, the sample statements explain the goal of the technology and its ultimate result, e.g., “This product contains high oleic acid soybean oil from soybeans developed using biotechnology to decrease the amount of saturated fat.” Id. at 4.

The approach outlined by FDA is supported by the results of the focus group testing that the Agency conducted from which it is apparent that consumers prefer labeling that explains the purpose and result of the biotechnology process. Specifically, the report concludes that the participants “preferred label statements that give them more information about how and why a product was bioengineered.” Focus Group Report at 5.

FMI believes the approach outlined in the Draft Guidance is a good model for voluntary claims regarding the use of biotechnology because it is informative for consumers; accordingly, we support the approach extended by FDA in the Draft Guidance for statements regarding the use of biotechnology in the manufacture of food or ingredients.1   Informational labeling will assist consumers in making educated choices about the foods that they eat. As noted in the Focus Group Report, participants rejected the option of warning-type labeling for products of biotechnology because a caution statement was seen as overly negative and too prescriptive. Focus Group Report at 5.

      2.     Statements about foods that are not bioengineered or that do not contain ingredients produced from bioengineered foods
     
In addition to the section on claims regarding the use of biotechnology, the Draft Guidance includes information on statements that may be made regarding the absence of biotechnology in the production of a food product or its ingredients. (For simplicity, statements or claims of this nature are referred to as “absence” claims in this section.) The Draft Guidance provides examples of acceptable absence claims and discusses the bases for these statements.

Our policy statement recommends that FDA establish clear standards for the use of absence claims. As with statements regarding the use of biotechnology discussed above, FMI believes that descriptive claims that provide consumers with information about the absence of biotechnology – such as “Our tomato growers do not plant seeds developed using biotechnology” – are generally more useful than non-descriptive claims. Accordingly, FMI generally supports the positions expressed in the Draft Guidance section on absence claims.

In addition to comments on the Draft Guidance’s treatment of absence claims generally, FDA specifically requested comments on whether absence claims are inherently implied superiority claims and, if so, whether such claims should be accompanied by “a clarifying statement . . . that the absence of the use of bioengineering does not make the food superior to food not so labeled.” 66 Fed. Reg. at 4840. Although not specifically stated, FDA seems to be alluding to the Agency’s “Interim Guidance on the Voluntary Labeling of Milk and Milk Products from Cows That Have Not Been Treated with Recombinant Bovine Somatotropin [rbST].” 59 Fed. Reg. 6279 (Feb. 10, 1994). In that case, FDA concluded that milk labels that bear a statement that the FDA-approved animal drug rbST had not been used to treat the cows that produced the milk should also bear additional information, such as the disclaimer that “No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”

FMI does not believe it is appropriate to follow the rbST example for statements that biotechnology was not used in the production of a specific food product and supports the treatment of absence claims expressed in the current Draft Guidance.

Claims that biotechnology was not used in the production of a specific food product are not inherently express or implied superiority claims in an absolute sense such that a disclaimer should be required in all instances. Rather, as FDA indicates in the Draft Guidance, the totality of the circumstances should be considered to determine whether a given “absence” claim includes an unlawful implication of superiority. A simple statement of fact – without graphics or other packaging elements that imply that food produced without biotechnology is safer or of a higher quality than food or ingredients produced with biotechnology – should not require a disclaimer.

In our opinion, factual statements regarding the production process – in this case, the absence of biotechnology – are comparable to labeling indicating that food was produced in accordance with Kosher law or organic methods. Each consumer’s view of the relative value of different production methods with respect to the ultimate food product is inherently based on the individual’s subjective values. Although, as FDA notes, the absence of biotechnology may not make the product safer or “of higher quality” in an absolute sense, people that hold certain moral or religious beliefs may prefer foods produced without biotechnology, in the same way, for example that foods produced in accordance with Kosher law are preferred by some religious adherents or that organic foods are preferred by others. A consumer’s view, though, that a given production practice is preferable should not require all statements that advise consumers of the production process to bear a disclaimer. Neither foods labeled as Kosher nor organic foods are required to carry a disclaimer regarding their relative value to foods produced through conventional processing techniques. Similarly, FDA should not suggest or require that foods that are labeled with lawful, factual claims that biotechnology was not used in their production to bear a disclaimer.

Indeed, focus group participants saw “little value in requiring disclaimers to disavow health or safety implications” of absence claims. Focus Group Report at 6. The focus group participants considered a disclaimer for absence claims as “forced and unnecessary” and often interpreted the idea of a disclaimer as a partisan stance that is pro-food biotechnology.” Id. Given this perception, a disclaimer is unwarranted and the recommendation that a disclaimer should be used might impact FDA’s credibility.

      3.     Substantiation of label statements

FDA’s Draft Guidance includes a section on the substantiation of label statements. Draft Guidance at 7. Specifically, FDA states that a manufacturer who claims that a food or its ingredients, including foods such as raw agricultural commodities, is not bioengineered should be able to substantiate that the claim is truthful and not misleading. Id. The Agency continues by noting that, if reliable validated testing is available, it will generally serve as the most reliable way to substantiate a claim that the resulting food product was not produced through biotechnology. Id. However, if reliable methods are not available, FDA recommends that procedural safeguards, such as special handling, recordkeeping to document segregation, and certifications from farmers, processors and others in the food distribution chain may be adequate to document that foods are obtained from the use of traditional methods. Furthermore, the Agency notes that the practices and recordkeeping that substantiate the “certified organic” statement would be sufficient to substantiate a claim that a food was not produced using bioengineering.

Although we generally agree with the approach FDA outlined, we have two comments. First, the section only addresses the substantiation necessary for claims made regarding the absence of biotechnology in the production of food. We strongly recommend that the Agency add information on the substantiation that is necessary to support claims regarding the presence or use of biotechnology. For example, FDA’s guidance should explain the information necessary to support claims such as lower saturated fat or improved texture, which are two of the examples given in the “Statements about foods developed using bioengineering” section of the Draft Guidance.

Second, we recommend that the Agency amend the Draft Guidance to emphasize the direct relationship between the substantiation that is necessary and the nature of the claim. The Draft Guidance alludes to this issue in the statement that “it would be easier to document handling practices and procedures to substantiate a claim about how the food was processed than to substantiate a ‘free’ claim.” Draft Guidance at 7. However, we believe that the guidance would be more helpful if FDA developed this concept more fully.

*          *          *


We appreciate your consideration of our comments. If we may provide further information on this matter or if we may be of assistance in any other way, please do not hesitate to call on us.

Sincerely,

Tim Hammonds
President and CEO

Enclosures
          

cc:     Mr. Joseph Levitt, Director
     Center for Food Safety and Applied
       Nutrition

1   We do have some reservations about the Agency’s suggestion that “genetically engineered” might be an appropriate label for use on a voluntary basis. Given the results set forth in the Focus Group Report, a generic “genetically engineered” statement might be misleadingly vague or misconstrued as “warning-type” labeling.