USCA White Paper, August 11, 2004

Executive Summary

Congress enacted protection for consumers as part of the Nutrition Labeling and Education Act of 1990 (NLEA) that required the U.S. Food and Drug Administration (FDA) to mandate disclosures by manufacturers about the nutritional value of purchased foods. The mandatory disclosures include specific statements about the amount of each essential or well-established nutrient in each serving size of an offered product in a Nutrition Facts part of the label. Thus, there is mandatory disclosure of the exact amount and percentage in relationship to a daily diet of each healthy or required nutrient with the solitary exception of cis-polyunsaturated fat.[1] Alternatively, if the food product does not contain a required nutrient, there must be a specific disclosure of that absence. The required information on a food label also includes mandatory disclosures about the presence, in a purchased food, of substances generally viewed as unhealthy when consumed in excess amounts, such as saturated fat, cholesterol, sodium, and recently, trans-unsaturated fat. In sum, the consumer reading the Nutrition Facts panel is entitled to know the amount per serving and percent Daily Value of each essential or beneficial nutrient and also each potentially unhealthy substance in a food product.

However, in implementing this mandate, FDA made one omission. There is no required disclosure about healthy or essential fatty acids in the Nutrition Facts panel. All current declarations about the amount or percentage of minimum daily needs of cis-unsaturated fat are voluntary. Thus, the consumer is deprived of important nutritional information mandated by the NLEA: the amount of healthy cis-unsaturated fat and the percentage of this fat as a part of known daily needs or, as with other essential nutrients, a specific declaration that the product is not a significant source of this essential nutrient. Cis-polyunsaturated fatty acids (PUFAs) are essential nutrients for all humans. This omission is striking and should be corrected. We suspect that at the time of the initial promulgation of the regulations, a contingent within the nutrition community contended that the healthiest fat consumption was the lowest possible and mistakenly applied this thinking to all fats, including essential fats, possibly based on the generally high fat consumption in the American diet. We now know this to be untrue. First, as recognized by worldwide health authorities and the medical community, healthy fats are an essential and necessary part of the human diet. Maintenance of good health is not possible without the consumption of a diet containing a minimum of the essential fats linoleic acid (LA) and alpha-linolenic acid (ALA). Second, growing evidence also suggests that healthy fat consumption is necessary to reduce obesity or, consequently, that healthy fat consumption may displace unhealthy fat consumption. Recent studies have shown that weight loss diets with substantial amounts of essential cis-unsaturated fats and proteins, but reduced levels of carbohydrates, and without imposed caloric restriction, are at least equally effective as intensive caloric restriction in inducing weight loss. These studies suggest that the low fat, high carbohydrate diets implicit in the current nutrition label may not induce satiety without calorie counting and, thus, could contribute to obesity. Third, healthy cis-unsaturated fats, whether poly- or monounsaturated, are not associated with risk for heart disease, stroke, cancer, or other medical condition. Indeed, healthy cis-unsaturated fats, especially omega-3 fatty acids, may reduce the incidence of acute and chronic heart disease. The declaration and acknowledgement of the necessity of essential fatty acids as a mandatory minimum component in the diet should be a prime consideration in the upcoming revision of federal nutrition guidance and regulations. Fourth, restrictions on the use of health claims for products composed of healthy unsaturated fats, based solely on their unsaturated fatty acid content, should be revised or clarified to reflect the absence of any risk from appropriate necessary amounts of unsaturated fat in the diet.[2] Finally, the absence of recognition of the need for healthy fats in the diet in the Nutrition Facts panel and under other U.S. guidance and regulations should be corrected. The absence of any recommendation about necessary minimum unsaturated fat consumption by FDA stands apart from the recommendations of major international and national public health nutritional guidance, including the National Institutes of Health.

The Nutrition Facts panel is further flawed because the regulations require the manufacturer to misleadingly inform consumers that there is no lower limit of healthy fat content in the diet below which the consumer should not go. In contrast to every other healthy and required nutrient, the consumer is advised that any level of fat consumption below 65 grams in a 2,000- calorie diet is satisfactory. This is simply not true since there is an essential need for certain unsaturated fats in the diet. In contrast, minimum recommendations are set for all other essential nutrients: protein, carbohydrates, dietary fiber, vitamins, and minerals.

The omission of a required declaration for cis-unsaturated fats contrasts with other areas of voluntary federal nutrition regulations. For instance, FDA has promulgated a health claim that acknowledges that a diet low in saturated fat and cholesterol may reduce the risk of heart disease. Such a diet, given the essential dietary need for cis-unsaturated fats, must of course preferentially include these fats. It must also authorize manufacturers of healthy fats or oils that are sold as meal preparation ingredients to label their product with a statement that when consumed as part of a daily diet, the product may reduce the risk of heart disease and stroke.[3] Nutrition content claims are permitted that tout the benefits of cis-unsaturated fat, an increase in cis-unsaturated fat relative to other comparable oils, or the relative absence of saturated fat relative to other oils. The agency has recently promulgated new regulations for trans-unsaturated fats that would similarly permit manufacturers of cis-unsaturated oils to make comparative nutritional content statements relative to these unhealthy fats. Additionally, as newer research has shown the potential benefits of omega-3 unsaturated fat, the agency has recently permitted statements about this healthy fat. The agency has permitted the touting of potential cardiovascular benefits of consuming oils containing omega-3 fatty acids. Finally, agency action or inaction in response to submitted claims related to structural or functional activities for dietary supplements also permit touting omega-3 fatty acid nutrient content. These permissible claims provide further support for the need to amend mandatory labeling requirements to require disclosure of cis-unsaturated fatty acid content in amount per serving and percent Daily Value. In addition, the FDA should clarify the applicability of health claims to healthful fats and oils.

The U.S. Canola Association believes that the time has come for mandatory recognition of the need for healthy fats in the diet and clarification of any voluntary labeling conditions that might restrict consumer information about the healthfulness of dietary unsaturated fatty acids. Canola oil itself serves as a prototype of an ideal healthy oil with its commercial availability, high content of cis-PUFAs (ALA and LA), its almost negligible content of saturated fat (7%), especially in contrast to all other commercial oils, and its relatively high content of the omega-3 unsaturated fat ALA (11%). Canola oil is also a good source of vitamins E and K. Among commercially useful oils, canola is nutritionally the best. However, all healthy oils should be recognized by a required disclosure of quality. The declaration of the need for healthy fats on food labels should be mandatory.

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[1] See Section I for chemical classification and terminology applicable to fats.

[2] See, e.g., 21 C.F.R. ยงยง 101.73, 101.75 and discussion, infra, section V.

[3] The regulation clearly permits a health claim for the reduced risk of heart disease for prepared foods comprised of healthy fats based on the fact that they use an alternative to saturated and trans fats. While the regulation is not clear on its face that the same health claim would necessarily apply to the ingredients themselves, for those making their own baked goods or salad dressings, a common sense application recognizes that oil is never customarily consumed alone and thus, the health claim is available to pure canola oil. See, infra, Section VII.

USCA White Paper.PDF

I. ESSENTIAL FATTY ACIDS AND FAT NOMENCLATURE

II. CANOLA OIL

III. RECOMMENDED HEALTHY FAT INTAKE BY PUBLIC HEALTH AUTHORITIES

IV. CONSUMER INFORMATION ABOUT DIET AND HEALTH

V. FDA SYSTEM FOR MAKING FOOD HEALTH CLAIMS

VI. NUTRIENT CONTENT CLAIMS

VII. HEALTH CLAIMS

VIII. STRUCTURE/FUNCTION CLAIMS APPLICABLE TO CANOLA OIL

IX. SUMMARY OF PERMISSIBLE CLAIMS APPLICABLE TO CANOLA OIL

REFERENCES

GLOSSARY

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