Dear Ms. McMurry and Members of the Dietary Guidelines Advisory Committee:

The Grocery Manufacturers of America (GMA) appreciates the opportunity to provide the 2005 Dietary Guidelines Advisory Committee with a final set of comments before the Committee concludes is work. GMA applauds the leadership of the Departments of Agriculture and Health and Human Services in their critical effort to help Americans lead healthier lives and to reduce the risk of chronic disease – especially at a time when there is a great deal of confusion about what constitutes a balanced diet, when Americans are more sedentary than ever, and when the problem of obesity is at the forefront of concern.

In these comments, we would like to address some specific concerns regarding trans fat, sugar sweetened beverages, whole grains, enriched grains and, in general, the need to achieve energy balance in order to maintain a healthy weight. We would also like to remind the Committee that the best way for Americans to make the revised Dietary Guidelines a part of their daily decisions is to make them achievable and relevant to their current lifestyle patterns and cultural needs.

Trans Fat
GMA’s member companies take the public concerns about trans fat seriously and are working diligently to address these concerns. In fact, the food industry has made great strides in its efforts to reformulate products to lower trans fatty acids levels by reducing or eliminating the partially hydrogenated vegetable oil content in the food supply. However, we believe strongly that any new or reformulated products need to be healthier than the products they replace, and that the call for mandatory “zero” trans fat in processed foods discussed at the May meeting of the Dietary Guidelines Advisory Committee could lead to unintended consequences.

Despite the intense public scrutiny regarding trans fat, saturated fat consumption remains a public health concern. Removing trans fat “at any cost” could lead to a return to oils with higher saturated fat content and products that have a less healthy, total fat profile than the products they are intended to replace. Therefore, GMA has called upon U.S. Food and Drug Administration (FDA) to adopt policies that foster the development of healthier products for American consumers and not to focus on only one element of the overall nutritional profile. Let me elaborate briefly with three simple points:

Point 1: The processed food industry is addressing trans fat in a serious way.
The processed food industry has always responded to new scientific evidence and the resultant regulatory policies. Since last summer, our member companies have been revising their nutrition labels to add quantitative labeling of trans fat in accordance with new FDA regulations. We also strongly support the Dietary Guidelines’ educational efforts to inform consumers about the role of trans fat, saturated fat and cholesterol in proper dietary management.

GMA members, working in tandem with the fats and oil industry, have also made considerable R&D investments in finding alternative ingredients that reduce or eliminate trans fat without increasing saturated fat in any significant way. These R&D efforts seek to merge the health benefits of alternative ingredients with necessary functional elements such as taste, texture, structure, and shelf stability. Equally important is evaluation of product performance differences in the reformulated products as is or as ingredients for recipe use applications in the home.

It should be noted that removing or reducing trans fat does not come without challenges. Some of these, such as reformulation to achieve the same taste, appearance, stability and performance, are widely known. Less understood are challenges in sourcing replacement ingredients, availability in commercial quantities, adjustments to equipment to receive, store and use alternative ingredients, and adjustments to cooking, handling and packaging, with resulting impacts on efficiency and productivity. Even if a promising substitute for a trans fat-containing ingredient is found, it must be assessed as part of a complex evaluation process that requires substantial investment of time and resources. The elements of this evaluation typically include, among other steps: research and development work; sensory evaluation, both initially and then throughout the product’s shelf life; in-plant modifications, adjustments, and scale-up efforts; product stability studies; potential packaging modifications; labeling revision; and potential distribution and warehousing modifications. Modification of distribution systems could include requirement for more refrigerated delivery systems, cooler warehousing, etc. GMA has prepared a preliminary summary of a “typical” product reformulation process (see Appendix A). If all goes well, a “typical” process can require several years, thousands of personnel hours and millions of dollars.

Point 2: The food industry’s guiding principle for reformulation is that any new or reformulated products should try to be as healthy, if not healthier, than the product it replaces.
It is a cardinal principle that we always want to be taking a step forward, not a step back. Accordingly, whenever possible, we believe that any new or reformulated products need to have improved fatty acid profiles compared to the products they replace. As GMA learned in consumer research conducted on our behalf by the International Food Information Council, overemphasizing a particular type of fat led consumers to disregard other components of the nutrition label such as saturated fat, cholesterol and total fat content. This means we must look at the total amount of fats, and the total amount of saturated plus trans fat in the product, and not focus exclusively on trans fat content. The goal should be that any decreased levels of trans fat should be replaced with no increase or with as small an increase in saturated fat as possible, and at most by an equivalent increase in saturated fat, in as many product categories as technologically feasible.

It is also essential that food companies take the time needed to “get it right” so that product evolution is responsible and responsive to today’s health concerns. Our members have been vigorously pursuing this goal, and have already made significant progress in a short period of time. Some of these examples were submitted to the Committee in earlier comments. Given the industry commitment, we will see an increase in the introduction of products with more favorable fatty acid profiles. Examples of proposed product re-formulations currently undergoing product performance and stability testing can be found in Appendix B.

Point 3: Care is needed to avoid unintended consequences.
As we move forward, it is absolutely essential that we take great care to avoid unintended consequences. Finding appropriate substitute ingredients to replace those that contain trans fat presents significant technological challenges that need to be overcome. That takes time, dedication, and patience. If companies are compelled to eliminate trans fat before a better substitute is developed – so that significantly higher levels of saturated fat such as tropical oils are used instead – it would be a major step back for public health and an enormous disservice to American consumers. Part of the Dietary Guidelines educational efforts about trans fat should include a cautionary note that it is overly simplistic to rely upon the word “hydrogenated” in the ingredients list as an indication of whether trans fat is present in the food at dietarily significant levels. Many products that contain partially hydrogenated oils contain these ingredients at extremely low levels that do not rise to nutritional significance; other products contain fully hydrogenated oils (e.g., high stearate soybean oils) that not only do not contain trans fat, but also contain saturated fat in the form of stearic acid, which a substantial body of evidence suggests is cholesterol neutral . GMA also recommends that information on stearic acid be included in dietary guidelines educational materials.

There is the distinct possibility of being confronted with the unintended consequence of companies removing trace amounts of partially hydrogenated oils (<0.5 g) and substituting an alternative ingredients that have higher levels of saturated fats than the original formulation simply to prevent the term “partially hydrogenated oils” from appearing in the ingredient listing.

In conclusion, we urge the Dietary Guidelines Advisory Committee to develop and support policies that promote improved total fat profiles and not to pursue directions that single-mindedly target trans fat.

Sugar-Sweetened Beverages
GMA is concerned with the Committee’s approval of the conclusive statement: “There is evidence that sugar sweetened beverages are not as well regulated as calories in solid form.” Consumers may interpret this statement to mean that they should avoid all beverages if they are to effectively regulate their total caloric intake. However, there is significant evidence regarding the health benefits of sugar sweetened beverages such as tea, flavored milk and cranberry juice. A recent study has shown no satiety deficit after consumption of a beverage relative to a solid food. There was no evidence for differential energy compensation after a beverage relative to solid food . Cranberry drinks and other commonly sweetened beverages such as teas provide rich sources of antioxidants in the form of flavonoids and other phenolics. Epidemiological research suggests that diets rich in flavonoids may reduce risk of various diseases such as cardiovascular diseases and some cancers. Flavonoid-rich beverages are inherently astringent due to their tannin content and require sweetening for palatability. In the proceedings of the National Academy of Sciences, it was found that tea boosts the immune system five-fold against disease. Two flavonoids in green tea – epigallocatechingallate (EGCG) and epigallocatechin (EGC) – are known to help prevent cancer. Green tea also helps in lowering cholesterol.

Flavored milk, widely enjoyed by children, provides a powerhouse of nutrients such as calcium and vitamin D that are difficult to match in other foods .

Pure cranberry juice is quite different from other juices. It is much higher in acid and lower in sugars than other fruit juices and is similar to lemon and lime juices. These low-sugar, high-acid juices require sweetening to be palatable. For example, the most popular cranberry beverage today is cranberry juice cocktail, a sweetened beverage of approximately 27 percent cranberry juice . A growing body of clinical and mechanistic research has shown that cranberry beverages, including cranberry juice cocktail, can significantly reduce the incidence of urinary tract infections (UTIs) , . UTIs are a serious health problem affecting millions of people each year and are second only to respiratory infections in frequency of occurrence.

We believe that it is important to note the positive role that, in the context of an energy-balanced diet, nutrient-dense sugar-sweetened beverages can provide important nutrients and health benefits. The benefits may be derived from traditional micronutrients as in the case of calcium and vitamin D in flavored and sweetened dairy beverages, or from phytonutrients in fruits such as cranberry and teas.

Whole Grains and Enriched Grains
Whole grains are or can be a dietarily significant component of a broad category of foods including breads, ready-to-eat and hot cereals, crackers, grain snacks and bars, pasta, rice dishes, grain side dishes, and main meals and dinners. The many different types of food that can incorporate significant quantities of whole grain provide an excellent opportunity to increase whole grain consumption that is consistent with public health recommendations.

Research has shown that there are numerous health benefits associated with regular consumption of whole grains. For example, information was presented to the Committee on January 28, 2004 that included findings about the health benefits of whole grain. Dr. Joanne Slavin of the University of Minnesota presented data and testified that the benefits of whole grain are not limited to its fiber content, as whole grains also provide antioxidants, phytoestrogens, oligosaccharides, vitamins, minerals, and resistant starch. Dr. Slavin also presented studies that showed whole grains contribute to weight loss as well as contain protective properties against cardiovascular disease, cancer, diabetes and obesity . In light of the favorable scientific evidence that points to the health benefits of whole grain, the 2005 Dietary Guidelines will recommend that consumers increase their consumption of whole grains.

However, studies have shown that Americans fail to consume the recommended servings of whole grains for a variety of reasons, including their inability to correctly identify whole grain foods. For example, ingredient lists often include “rolled oats,” which does not immediately convey to the consumer that it is a whole grain ingredient.

As a way to facilitate increased consumption of whole grains as part of the total diet, one of GMA’s member companies has petitioned FDA to allow the use of whole grain descriptor claims, including “excellent source” and “good source.” Adoption of whole grain claims would encourage consumption of whole grain foods, help to eliminate consumer confusion about whole grain products, provide an incentive for manufacturers to increase the whole grain content of their products and, thus, provide a substantial benefit to public health. By providing consumers with increased information about good nutrition and health benefits, consumers are better equipped to combat chronic disease and obesity.

Additionally, we believe it is important to emphasize the positive role that enriched, fortified grains can play in the total diet. As GMA explained in comments submitted to this committee on April 26, 2004, one of the most significant contributions of enriched grains to the diet is the delivery folic acid for women of child-bearing age. Scientific research supports the important nutrient contributions made by refined, enriched grains in the diet. Recent reports indicate that grains enriched with folic acid have contributed to 31,000 fewer deaths from stroke and 17,000 from heart disease each year from 1998 to 2001. In addition, another report has shown a 23 percent drop of neural tube defects in live births, which is attributed to the FDA-mandated folic acid fortification of enriched grains and cereals. Additionally, since fortification was mandated in 1998 in both the United States and Canada, infant neuroblastoma has dropped 60 percent in Canada.

Energy Balance
Last September, when the Dietary Guidelines Advisory Committee began the important process of drafting the new Guidelines, GMA submitted comments calling on Americans to moderate their food intake based on their level of physical activity. On this point, GMA is aligned with the positions of leading health associations, researchers, and fitness experts that maintaining a healthy weight is best achieved by balancing a caloric intake with daily physical activity – or energy balance. Additionally, the U.S. Centers for Disease Control and Prevention has stated that creating an environment that supports this balance is essential to reducing the country’s obesity epidemic.

GMA’s philosophy is to encourage a comprehensive approach to energy intake and energy expenditure, and believes it is vital to educate Americans on the best way to achieve energy balance. GMA continues to recommend that the Committee emphasize the importance of maintaining a balance between the number of calories consumed and calories burned through daily activities and regular exercise.

Communicating Nutrition & Activity Messages to Consumers
Consumers today are clamoring for information about how they can improve their overall lifestyles through the foods they eat and the activities in which they participate. It will be up to the collective efforts of the government, industry and other stakeholders to ensure consumers receive the valuable information provided in the guidelines that will be understandable and achievable on leading healthful lives.

It is clear that the Committee has a powerful opportunity to draft guidelines that help consumers lead healthy and active lives by giving them information about the critical roles of both nutrition and physical activity as part of a healthy lifestyle. There is little doubt that today’s consumer wants this kind of information, and communicating information about the 2005 Dietary Guidelines to Americans must be a key part of the final product.

We look forward to working with this Committee, USDA and HHS in the disseminations of the 2005 Dietary Guidelines for Americans, and are happy to answer any questions you may have.

Sincerely,
Alison Kretser, MS, RD

APPENDIX A

Select Steps in the Development of Food Productswith No or Reduced Trans Fat

I. Concept/Strategy Phase (3-6 months if suitable alternative available, 2-3 years if not)

• Identify suitable alternatives to fats and oils with trans fatty acids.
• Suitable alternatives to trans fat may be limited in some product categories. For example, for confectionery, the only currently available options that are suitable from a technological perspective are tropical oils. Development of new technologies requires a longer timeframe, especially if coupled with use of oilseeds with modified fatty acid composition.
• Confirm availability of supply at appropriate volumes.
• Time needed for reformulation will vary depending upon the availability of suitable alternatives at necessary volumes. For example, modified soybeans that produce oil that does not require hydrogenation are in development, and could be of interest for many products, but significant production volume could be 2-3 years away, at best.
• Availability of modified agricultural oilseeds and their products requires use of identity preservation programs at all stages of development (i.e., seed company, farmer, grain elevator, seed processor, ingredient manufacturer, and finished food company).
• Ingredient suppliers may themselves undergo substantial production and other modifications in order to supply new or modified ingredients, which adds time and expense to the process.
• Develop product reformulation design and plan.
• Assess pertinent regulatory requirements, including global ramifications.

II. Research and Development/Preliminary Sensory Evaluation (6-12 months)

• Use bench-top testing to identify key product variables for current products (i.e., a gold standard or control).
• Schedule promising substitute products for preliminary sensory evaluation using professional testing panels (in-house and/or external).
• Conduct preliminary consumer testing.
• Conduct analytical testing of proposed formulations as necessary to examine nutritional, compositional stability and other properties.
• If differences between the control and proposed substitute are found, additional research may be conducted to identify process and other changes to reduce differences.
• Desired changes may extend to modifications of ingredients by suppliers, which initiates another R&D cycle to modify and produce ingredients with desired properties.

III. Pilot Plant Production and Scale-Up to Commercial Operations (6-18 months)

• Assess necessary adjustments to equipment that receives, stores, and uses alternative ingredients.
• Evaluate necessary adjustments to holding, mixing, cooking, processing, cooling, handling, and packaging processes in light of efficiency and productivity targets.
• Develop revised raw material specifications and acceptance criteria.
• Evaluate consumer preferences.
• If product is unacceptable, product development process must begin anew, which may extend back to the level of the ingredient manufacturer.
• Plan for scale-up of production (i.e., production at commercial quantities), including capital equipment modifications and adjusted processing parameters.
• Conduct shelf-life studies (can be particularly important and challenging when modifications to fat content are involved).
• Make final contractual and other arrangements for supply of new ingredients and materials, as needed.
• Note: with certain bulk system designs, it may not be possible to change only some of the products a plant produces without manufacturing plant re-design.

IV. Packaging and Labeling (3-6 months)

• Assess need for changes in packaging materials (may include improved barrier and/or modified atmosphere packaging).
• Conduct analytical work for revised nutrition labeling.
• Develop revised Nutrition Facts Panels and ingredient lines.
• Evaluate revised labels for regulatory compliance.
• Conduct consumer testing of revised packaging and labels.
• Make plans for label transitions and use of old labels.
• Align package/label transitions with implementation of product changes or plant conversions.

V. Product Development Summary (Total time 18 months-6 years)

• Industry segments affected by change in vegetable fats and oils: All segments, from seed companies, to elevators, to seed processors, to ingredient manufacturers, to finished product manufacturers. For new ingredients created from current commodity oilseeds, ingredient manufacturers and finished product manufacturers bear the greatest burden. However, if a new ingredient is derived from a minor oilseed or a new oilseed with a modified fatty acid profile, then from an agronomic production standpoint, all segments could be impacted.
• Number of plants per manufacturer affected: Varies, but changes to a single product or group of products can affect numerous plants simultaneously, adding substantially to complexity and cost.
• Analytical testing: Can be extensive, requiring analysis of modified nutrition profiles, organoleptic properties, and other factors. One company reported more than 240 analytical tests associated with a reformulation effort.
• Consumer testing: A typical change may require dozens of consumer testing panels.
• Capitol expenditures: Can approach tens of millions of dollars per company.
• Personnel hours: One company reported 7000+ personnel hours.
• Total time for new product development that may be required: Varies, but can easily approach one-and-one-half to six years.

References
See, e.g., Transcript of Food Advisory Committee, Nutrition Subcommittee Meeting, Total Fat and Trans fat (Apr. 27-28, 2004) (statements of A. Lichtenstein).
Drewnowski, A., et al.; “No satiety deficit after consumption of a beverage relative to a solid food,” Abstract # 3530; Experimental Biology Annual Meeting, April 2004.
Lagiou P, Samoli E, Lagiou A, Tzonou A, Kalandidi A, Peterson J, Dwyer J, Trichopoulos D. Intake of specific flavonoid classes and coronary heart disease – a case-control study in Greece. Eur J Clin Nutr. 2004 June 30 [Epub ahead of print].
Mennen LI, Sapinho D, de Bree A, Arnault N, Bertrais S, Galan P, Hercberg S. Consumption of foods rich in flavonoids is related to a decreased cardiovascular risk in apparently healthy French women. J Nutr. 2004 Apr; 134(4):923-6.
Knekt P, Kumpulainen J, Jarvinen R, Rissanen H, Heliovaara M, Reunanen A, Hakulinen T, Aromaa A. Flavonoid intake and risk of chronic diseases. Am J Clin Nutr. 2002 Sep; 76(3):560-8.
Arts IC, Jacobs DR Jr, Gross M, Harnack LF, Folsom AR. Dietary catechins and cancer incidence among postmenopausal women: the Iowa Women’s Health Study (United States). Cancer Causes Control. 2002 May; 13(4):373-82.
Palermo CM, Hernando JI, Dertinger SD, Kende AS, Gasiewicz TA. Identification of Potential aryl Hydrocarbon Receptor Antagonists in Green Tea. Chem Res Toxicol. 20003, Jul 21;16(7): 865-72.
Frary CD, Johnson RK, Wang MQ. Children and adolescents’ choices of foods and beverages high in added sugars are associated with intakes of key nutrients and food groups. J Adolesc Health. 2004 Jan; 34(1):56-63.
Leahy, MM, Roderick R, Brilliant K. The cranberry – promising health benefits, old and new. Nutrition Today 2001; 36:254-265.
Raz R, Chazan B, Dan M. Cranberry juice and urinary tract infection. Clin Infect Dis. 2004 May 15; 38(10):1413-19.
Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.
Presentation of Dr. Joanne Slavin, University of Minnesota to the Dietary Guidelines Advisory Committee, January 28-29, 2004. (Attachment)
Yang, Q, Buxton, W.; “Improvement in stroke and ischemic heart disease mortality after flour fortification with folic acid in the United States”. Paper [unpublished] presentation, American Heart Association Annual Conference on Cardiovascular Disease, Epidemiology and Prevention, March 5, 2004.
French AE, Grant R, Weitzman S, Ray JG, Vermeulen MJ, Sung L, Greenberg M, Koren G. Folic acid food fortification is associated with a decline in neuroblastoma. Clin Pharmacol Ther. 2003 Sep;74(3):288-94.

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