| Comment Record|
Mrs. Alison Kretser ||
2002-12-16 17:04:27 |
Grocery Manufacturers of America |
| Comments for FDA General |
1. General Comments
December 16, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, Maryland 20852
RE: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Reopening of the Comment Period; 67 Fed. Reg. 69171 (Nov. 15, 2002) Docket No. 94P-0036
The Grocery Manufacturers of America (GMA) appreciates this opportunity to offer comments concerning the Food and Drug Administration (FDA) proposal to require that the footnote statement “Intake of trans fat should be as low as possible” be provided each time that trans fat is listed in the Nutrition Facts box.
GMA is the world’s largest association of food, beverage and consumer product companies. With U.S. sales of more than $460 billion, GMA members employ more than 2.5 million workers in all 50 states. The organization applies legal, scientific and political expertise from its member companies to vital food, nutrition and public policy issues affecting the industry. GMA speaks for food and consumer product manufacturers and sales agencies at the state, federal and international levels on legislative and regulatory issues. The association also leads efforts to increase productivity, efficiency and growth in the food, beverage and consumer products industry.
GMA strongly opposes the proposed use of the footnote statement “Intake of trans fat should be as low as possible”. The proposed use of the footnote statement is inconsistent with other nutrition fact elements. The precedent setting nature of requiring this type of language is of particular concern. GMA strongly opposes the proposed use of the footnote statement “Intake of trans fat should be as low as possible” for the following reasons:
TECHNICAL MERITS OF THE PROPOSED STATEMENT
The footnote statement “Intake of trans fat should be as low as possible” is alarming in tone, confusing, and ultimately will function as a de facto warning label. The footnote conveys a misleading negative impression as to the relative significance of trans fat as compared to saturated fats and other macronutrients on the nutrition label. Incorporated into the current Nutrition Facts panel format, the proposed footnote statement would indicate to consumers that trans fat should be avoided entirely, while there is a “safe level” for consumption of saturated fat. This could steer consumers to choose products with more saturated fat than trans fat. Thus, what the agency is proposing to do in the name of promoting public health will divert attention from saturated fat and may lead to less healthful food consumption patterns by driving higher saturated and total fat intake as consumers begin to disregard both saturated and total fat content.
The FDA has stated in its proposed rule that the footnote statement “is taken from the Institute of Medicine/National Academy of Sciences (IOM/NAS) Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids Report [the so-called “Macronutrient Report”] and is consistent with dietary guidance in other recent scientific reports referenced in this document.” Although the agency has based the footnote upon a statement that appears in this report, the agency has taken the IOM/NAS Panel’s statement out of context. Read as a whole, the Panel’s recommendations concerning trans fat include the following key ideas:
· A certain amount of trans fat is unavoidable in ordinary, non-vegan diets;
· Attempts to avoid trans fat entirely would require extreme measures and could result in nutritional risk;
· Trans fat consumption should be as low as possible while consuming a nutritionally adequate diet (i.e., consumers should focus first on nutritional adequacy, while avoiding trans fat to the extent that doing so does not compromise intake of essential nutrients).
A statement that conveys only a fraction of these messages oversimplifies the IOM/NAS Macronutrient Report and sends a false and misleading message to consumers.
The IOM/NAS Report did not establish a Dietary Reference Intake (DRI) upon which a Daily Reference Value (DRV) and Daily Value may be based, and FDA likewise states in the proposed rule that it has insufficient data to establish a reference value for trans fat. By characterizing the recommended trans fat intake as FDA has in their footnote statement (and thus acting, in effect, as a nutrient content claim), the proposed footnote establishes a de facto Daily Value and tolerable upper intake level (UL) of zero grams per day. The IOM/NAS report, however, indicates a UL of zero would be inappropriate:
“Because trans are unavoidable in ordinary, non-vegan diets, consuming zero percent of energy would require significant changes in patterns of dietary intake. Such
adjustments may introduce undesirable effects (e.g., elimination of commercially prepared foods, dairy products and meats that contain trans fatty acids, may result in inadequate intakes of protein and certain micronutrients) and unknown unquantifiable health risks” (1).
Clearly, the IOM/NAS Panel never intended for the American diet to strive towards a zero gram intake of trans fatty acids.
The proposed statement is also troubling because the premise upon which it is based—that virtually any level of trans fat intake can be linked to increased risk—is being called into question. An article referenced by the IOM/NAS Panel on Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids for its assessment of the effect of trans fatty acids was a sounding board article that was not peer-reviewed (2). The article included a figure that had not been previously published elsewhere, information that may not be considered under IOM/NAS policy, which requires strict reliance on published data only. The regression line in this figure was extrapolated to force the data point to zero intake of trans fats. Such a manipulation is beyond the threshold of sensitivity of the data, which are unreliable once trans fat intake falls below three percent of total caloric intake. Thus, the validity of some of the conclusions in the final IOM/NAS report are in question.
CONSUMER ACCEPTANCE AND UNDERSTANDING
To ensure consumer acceptance and comprehension of nutrition labeling, the current Nutrition Facts format was adopted following careful consideration of consumer perception research. Any fundamental change to this established format likewise requires careful consideration of the impact that any such change will have on consumer acceptance and understanding. To date, there is no consumer education campaign for trans fatty acids in the United States. FDA is urged, therefore, to proceed with extreme caution before adopting any novel type of labeling (e.g., descriptive footnotes that characterize recommended intake levels) for trans fatty acids.
The basis for requiring quantitative information is well established for a recognized nutrient of nutritional significance, including trans fatty acids. Where sufficient information is available, the basis for establishing a reference value (i.e., Daily Reference Value or Reference Daily Intake) is similarly well established. A textual footnote of the type FDA is proposing, however, is not as simple, clear, or useful as a statement of percent Daily Value, nor is it at all clear that consumers will react to the proposed footnote in the manner that FDA anticipates.
Indeed, as suggested by Dr. Penny Kris-Etherton at the Georgetown University Ceres Forum, “Fat in the American Diet-The Science and Policy,” there is a very real risk that consumers may misinterpret trans fat labeling, and will require considerable education to ensure that the role of trans fat is not inappropriately over-emphasized relative to other nutrients, especially saturated fat:
“We absolutely have to provide some education about the context in which the recommendation is made and how consumers should follow that recommendation. This is why we have big problems with our recommendations. If we recommend decreasing trans fatty acids that is all they (the consumers) are going to do. If it is a separate line item on the nutrition label, they are going to forget all about saturated fat and as we have been saying, decreasing saturated fat is more important because we are eating a lot more of it (saturated fats)”(3).
Meaningful education of the type proposed by Dr. Kris-Etherton, a member of the IOM/NAS Panel on Dietary Reference Intakes for macronutrients, is not readily provided in a footnote.
Also at the same Ceres Forum, FDA Director of Consumer Research Dr. Alan Levy similarly made clear the challenge of conveying information regarding fatty acid nutrition to consumers in a meaningful fashion:
“I have some trouble with putting it (trans fat) on the label simply because the effects of putting something on the label that people have not heard of are quite uncertain. We have learned from our experience with saturated fat . . . that it is very hard to teach people the intricacies of fatty acid chemistry. In fact, I think that it is not a realistic goal. You are not going to have people appreciate some of these distinctions, and it really has not been only a failure in our messages or a lack of effort. There is a level of complexity that people will just not comprehend. People do not want to be burdened by making all these distinctions.”
GMA strongly opposes the use of a footnote statement that has not been tested through consumer research. To the best of GMA’s knowledge, we are unaware that any consumer testing has been conducted to evaluate the proposed footnote statement.
A simple, consistent, and uncluttered format is the best way for nutrition information to be observed and comprehended (4). For the following reasons, GMA believes the proposed footnote statement will be confusing to consumers by hindering comprehensive consumer understanding of the Nutrition Facts panel information.
First, information of several types and forms (e.g., quantitative declarations, Daily Values, cautionary footnotes, etc.) could confuse or frustrate consumers to the point that they avoid using the any of the provided information because they do not understand the differences or why multiple forms of information are used.
Second, the terminology used in the footnote statement is open to variable interpretation. The terminology “as low as possible” does not provide useful quantitative information to the consumer, particularly in the context of a nutrition panel where there will likely be much higher numbers listed for other nutrients, such as total fat and carbohydrates. For example, a product may contain 12 g of fat, 4 g of saturated fat, 3 g of trans fat, 40 g of carbohydrate and 30 g of sugar among the other nutrients listed in the Nutrition Facts
panel. It is not clear how consumers will interpret a footnote statement linked with trans fat and not the other nutrients when they observe such varying numbers.
Third, there is potential for consumer confusion regarding the significance of various nutrients. Consumers may be confused because saturated fat, cholesterol, sodium or other nutrients perceived as “undesirable” do not carry similar footnote statements advising that consumption or intake should be as low as possible. It simply is not feasible or realistic to provide characterizing nutritional advice, in the form of a textual statement, on the nutrition label for trans fat or any other nutrient for which dietary guidance would be beneficial for consumers.
Fourth, consumers may misinterpret the statement to mean that they should completely avoid any food with a trans fat content of more than zero and over-react by eliminating all foods with trans fat from their diets. There are many foods that contain trans fat that public health organizations would not recommend excluding from the diet such as commercially prepared foods, dairy products and meats. The IOM/NAS Report, as previously cited in GMA’s comments, noted that eliminating trans fat from the diet would potentially lead to extraordinary changes in patterns of dietary intake that “may result in inadequate intake of protein and certain micronutrients and unknown and unquantifiable health risks”. The footnote statement may lead to those undesirable effects and risks.
As it has for other nutrients that lack a DRV or RDI, FDA should require declaration of the amount of trans fat but leave the Percent Daily Value declaration blank. This approach is sound from both a legal and a policy standpoint because FDA historically has not required a Percent Daily Value declaration where there exist insufficient data to establish a DRV (e.g., monounsaturated fat, sugars) or other reasons make such a declaration unnecessary in certain circumstances (i.e., protein). Regardless of the chosen approach, prior to amending current labeling policy, the agency should ensure that any contemplated amendments do not interfere with the consumer’s understanding of information that is already required on the nutrition label.
GMA supports mandatory declaration of trans fat in the Nutrition Facts box. FDA should proceed to require manufacturers to label trans fat as a separate line entry in the Nutrition Facts panel. The quantitative amount of trans fat will be available to consumers, and provide consumers with the opportunity to compare the trans fat content in one product to that of another. There should be no DV or footnote statement in the present rule-making.
FDA has commissioned another committee of the IOM/NAS to prepare recommendations on how to apply the dietary reference intakes to labeling. This committee is the Committee on Use of Dietary Reference Intakes (DRIs) in Nutrition Labeling. The committee is just over half way through its deliberations and a final report is not expected
until October 2003. FDA should wait until all the DRIs have been issued and review the DRI recommendations as a whole before singling out one nutrient and, worse yet, presenting that information in a manner that uses only a portion of the committee’s recommendations in the macronutrient report. GMA believes a narrow focus on one nutrient will detract consumers from focusing on consuming a wide variety of foods while watching portion sizes and total caloric intake.
The nutrition label cannot, by itself, provide all the information important to maintaining healthy dietary practices. The role of the nutrition label should be to provide factual, product-specific information; broader dietary guidance should be provided through off-label activities of public and private health and nutrition education programs. In some cases, individuals should seek dietary counseling by a professional registered dietitian.
INDUSTRY ISSUES AND INCENTIVES
Due to limited space on many packaged food labels, compliance with labeling regulations presents a continuing challenge. Based on the proposal, it is unclear how the footnote statement will be reconciled with the existing abbreviated and simplified nutrition labeling formats. Will the agency change the criteria for use of the simplified format (i.e., will the threshold be increased from seven to eight nutrients)? The agency is urged to consider the need to accommodate differing package sizes, as well as the need to avoid labeling variations that are likely to perpetuate confusion. GMA is concerned that space limitations present yet another reason why the proposed footnote will be unworkable.
FDA has expressed a hope that trans fat labeling will prompt product reformulation to reduce trans fat levels. The proposed footnote statement, however, provides disincentive for manufacturers to make incremental changes in formulation to lower trans fat content (e.g., from 3 grams to 1 gram). Should a manufacturer choose to reformulate a product to lower the trans content of that product—the footnote statement will still be required. Unless a product reaches 0 grams of trans, the product will be judged as unacceptable by consumers if it contains the footnote language FDA is proposing. In certain food products, it is not technologically feasible to reduce the trans fat level below 0.5 grams. New fats/oils are not currently available in sufficient commercial quantities.
Also of concern, the footnote may prompt industry to reformulate in a manner that increases saturated fat content, in an effort to mitigate the impact of the dramatic footnote language. As requested by the agency during our December 13 meeting, we are including for the agency’s consideration labels for two reformulated products—one for margarine and one for cookie dough. As is evident from a side-by-side comparison of the labels prior to and following reformulation, levels of saturated fat in both products increased significantly as a result of reformulation to reduce trans fat content.
Stick Margarine-Current Formula Stick Margarine-New Formula
Refrigerated Cookie Dough Refrigerated Cookie Dough
Current Formula New Formula
In another example, in reformulation of fats to obtain the melt profile needed for compound coatings, the melt ranges of the trans components cannot be replaced with unsaturated fat, but can be more closely matched with shorter chain saturated fatty acids. Preliminary formulations have required an equal or greater amount of shorter chain components in place of the trans to duplicate the solids profiles.
GMA is concerned that the footnote statement violates the First Amendment. To satisfy First Amendment requirements, FDA must show that the footnote statement materially advances a significant governmental interest, and it must be narrowly tailored to
accomplish that purpose. The footnote statement, however, fails to advance a government interest because it is misleading.
Indeed, the footnote statement is contrary to one of the key goals in this rulemaking. In the 1999 trans fat proposal (6), FDA stated that, because the average intake of saturated fat exceeds that of trans fat by five fold, it is important that trans fat labeling not divert consumer attention away from risks associated with saturated fat. GMA believes the footnote will do just that – driving an increase in intake of saturated fat as consumers scurry away from all foods that contain trans fatty acids. Furthermore, this footnote statement will, in essence, suggest that total fat is not at issue – only the kind of fat. This message clearly flies in the face of sound dietary advice.
The revised FDA label may also violate international obligations of the United States in the World Trade Organization (WTO). The WTO Agreement on Sanitary and Phytosanitary Measures (SPS) requires that SPS measures be based upon sound science. The proposed footnote statement mischaracterizes the underlying science because it implies it is beneficial for consumers to aspire to a daily intake of zero grams of trans fat when the IOM/NAS has specifically advised that eliminating trans fats entirely in the diet would lead to greater harm by impeding dietary intake of essential nutrients. It is possible, therefore, to claim that the proposed FDA footnote statement represents a warning label that unfairly discriminates against a particular class of products, those that contain trans fats, without full consideration of all the scientific evidence on the macronutrients within the IOM/NAS Report.
GMA believes that the proposed footnote statement would be classified as an SPS measure because it is a requirement that is intended to protect human health. Even if it were not found to be an SPS measure, however, the statement would violate the WTO Agreement on Technical Barriers to Trade (TBT), which requires that “technical” regulations fulfill a legitimate purpose and be no more trade restrictive than necessary. As described above, the proposed footnote does not fulfill a legitimate purpose because it oversimplifies and misrepresents the scientific report on which it is based, the IOM/NAS report on DRIs for macronutrients. It is more trade restrictive than necessary because alternatives to characterizing footnote statements, notably consumer education, are available to assist consumers in understanding quantitative trans fat labeling in the absence of a reliable Daily Value.
Finally, GMA is concerned that the proposed footnote will raise yet another barrier to harmonization of FDA requirements for nutrition labeling with those of the U.S. Department of Agriculture (USDA). Harmonization with USDA requirements is of concern because the potential for disparate labeling and confusion is great when similarly
situated products are labeled in a different manner depending solely upon agency jurisdiction.
· GMA supports mandatory declaration of trans fat as a separate line entry in the Nutrition Facts box.
· GMA believes consumers would view the proposed footnote statement as a de facto warning label.
· GMA recommends that the proposed footnote statement be deleted and trans fats be identified only in regard to quantitative amount in the Nutrition Facts panel.
Alison J. Kretser MS, RD
Director of Scientific and Nutrition Policy
(1) Report of the Institute of Medicine of the National Academies: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids 2002 p. 8-2
(2) Ascherio A, Katan MB, Zock PL, Stampfer MJ, Willett WC 1999 Sounding Board -Trans fatty acids and coronary heart disease. N Engl J Med 340:1994-1998.
(3) Ceres Forum: Fat in the American Diet, The Science and the Policy, Proceedings, Georgetown University Center for Food and Nutrition Policy which today is known as the Virginia Tech Center for Food and Nutrition Policy.
(4) 58 Fed. Reg. 2122 (Jan. 6, 1993)
(5) Report of the Institute of Medicine of the National Academies: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids 2002 p. 11-47
(6) 64 Fed. Reg. 62746, 62755 (Nov. 17, 1999)