From: Joan C Dobbs [dobbs@hawaii.edu] Sent: Friday, June 03, 2005 6:30 PM To: Dockets, FDA Cc: dobbs@hawaii.edu Subject: Docket No. 2001N-0548 - opposition to changes Importance: High Reference: Docket No. [2001N-0548] PROPOSED RULE CFR Citation: 21 CFR 101 Published: April 04, 2005 [FR Doc. 05-06475] Federal Register Vol. 70, No. 63 To whom this may concern: The following is submitted in response to the Federal Register notice requesting interested parties to comment on FDA's proposal to amend its voluntary nutrition labeling regulations for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. I appreciate the opportunity to provide these comments in opposition to the proposed changes to the voluntary nutrition labeling regulations. As a nutritionist of 30 years, who has conducted nutrient analysis, worked as a food industry consultant, and as a nutrition educator, I oppose the presently proposed changes because: 1) these changes inadvertently mislead the public by giving an unwarranted impression of accuracy 2) are not consumer-friendly 3) will result in unnecessary reprinting costs to industry and those producing nutrition education materials. IMPRESSION OF UNWARRANTED ACCURACY Listing the weight of any fruit or vegetable in un-rounded numbers (e.g. honeydew melon 134 grams or 4.8 oz or lemon at 58 grams and 2.1 oz) gives an impression of an unwarranted level of accuracy. This in turn gives consumers two wrong impressions: 1)nutrient content for all varieties of a specific produce type is exactly the same and does not vary and 2)as a consumer they should be concerned at this level of detail for all of the nutrients listed. Based on two (2) previously published FDA comments, using un-rounded numbers is not in the public’s best interest. FDA comments to Restaurants listed at http://www.cfsan.fda.gov/label.html, U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition August, 1995; Revised February, 1996 “Questions and Answers VOLUME II A Guide for Restaurants and Other Retail Establishments; U.S. Department of Health and Human Services; Public Health Service Food and Drug Administration “R81. Question: Data base analysis indicates that a food contains 277 calories, 464 mg sodium, 39.22 g protein, and 5.81 g fat per serving. Can a restaurant use the same numbers that are generated by data base analysis (or provided in a cookbook or other source of nutrient content information) directly in its nutrition labeling? Answer: Yes. However, labeling that declares nutrient values in a way that implies an unwarranted degree of accuracy could be misleading. To avoid the impression of unwarranted accuracy, as well as to make nutrition labeling easier for consumers to review and understand, restaurants are strongly encouraged to follow the rounding rules set out in # 101.9(c) (see attachment A). To be consistent with these rules, the above values should be declared as 280 calories, 460 mg sodium, 39 g protein, and 6 g fat.” Directions to the food industry from FDA in terms of Reference amounts customarily consumed per eating occasion also indicates that in all cases except for very small serving sizes, information should be presented in a rounded weight form (Code of Federal Regulations 21CFR101.12 - Page 52-61 Revised as of April 1, 2004). In addition to these publications, it is well documented that soil nutrients (N,P, K) and growing conditions, level of ripeness and storage can make a large difference in nutrient concentrations in fruits and vegetables. Implying that these nutrient concentrations are exact takes these numbers out of the realm of science. NOT CONSUMER FRIENDLY Values presented are for “Edible Portion”. Consumers buy foods in “As Purchased” quantities. Especially in a fruit with a large amount of inedible content (i.e. cantaloupe or peach), a consumer would likely believe that they are getting more nutrients than they are. Having yield conversion factors would be necessary to make the nutrient information truly usable to the consumer. For example, an updated potassium value is of little worth if there is a large quantity of refuse and the consumer is not aware of this – even if the concentration of a nutrient is absolute per 100 grams of edible portion. UNNECESSARY REPRINTING COSTS Although computers have made printing educational materials easier, there is still a significant cost (money and resources) to reprinting materials that have minor changes. Therefore it would be both beneficial to those producing nutrient value information and to those using nutrient education materials to wait for a set of nutrient values that are based on rounded fruit weights and that also include yield information. Please feel free to contact me at dobbs@hawaii.edu or (808)956-3845. Respectfully, Joannie Dobbs, Ph.D., C.N.S. Assistant Specialist in Food Composition Human Nutrition, Food and Animal Sciences Department University of Hawaii at Manoa 1955 East West Road #216 Honolulu, HI 95822 The comments above are based on my experience and judgment and do not reflect any position or opinion of the University of Hawaii in general