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FDA-2016-N-2938 a Proposed Rule: Reference Amount Customarily

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FDA-2016-N-2938 a Proposed Rule: Reference Amount Customarily specialtyfood.com FDA-2016-N-2938 A Proposed Rule: Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used to Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments COMMENTS OF THE SPECIALTY FOOD ASSOCIATION January 3, 2017 The Specialty Food Association (SFA) welcomes this opportunity to submit comments regarding the Proposed Rule, Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used to Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products. SFA is commenting on the appropriate food category and Reference Amount Customarily Consumed (RACC) for nut butter spreads and the related 2014 Citizen's Petition. The issue is important to many SFA member companies, the majority of which are small and very small food businesses producing high value, trend setting specialty food products. The nut butter spreads and products category encompasses many specialty foods. Several of them compete with the product referenced in the Citizen's Petition. The Position of the Specialty Food Association SFA believes that the current RACC and two (2) tablespoons serving size is appropriate for nut butter spreads and products. It is imperative that consumers be able to easily make comparisons of the macronutrient amounts in foods they use in similar ways, which in this case includes traditional peanut butter and almond butter, as well as cocoa, cookie, and coffee flavored spreads. Maintaining the current RACC of two tablespoons for flavored nut butter spreads accomplishes that. Regarding the Citizen's Petition filed on behalf of Ferrero, U.S.A., Inc. (Ferrero), the data provided does not meet the standards to support a change in food category as demanded by FDA rules. Legally, the data provided to support a change in product category from dessert topping with a RACC of two (2) tablespoons to a marmalades category with a RACC of one {1) tablespoon is insufficient. There is a major commercial reason for denying (or at least not acting on) the Citizen's Petition. The requested change would distort the market by categorizing the product described in the Citizen's Petition as a product with a one (1) tablespoon RACC, instead of its current two (2) tablespoons. This would give an advantage to products like Nutella® with a smaller serving size than competing spreads like peanut butter. Nutella is merchandised at retail with nut butters and particularly alongside peanut butter. If, as the Citizen's Petition asks, the two products were l ( Pag e 136 Madison Avenue, 12th Floor • New York, NY 10016 • 212.482.6440 on the same shelf but with different serving sizes, the nutrition information would give an unfair advantage to the Petition product. In the market, competing products would have different serving amounts within their product line. This would increase the cost of marketing such products and create a more complicated regulatory scheme for producers. There would also be an uneven playing field if producers of traditional nut butters and spreads had to compete with "cocoa nut spreads" labelled with a smaller serving size and lower calorie, fat and sugar nutrition levels. The same would occur if the product category for the Petition product were changed to marmalades, which have a one (1) tablespoon serving size, even though ounce for ounce, they contain more calories/fat/sugar. This is the commercial reason for maintaining the current serving size. The purpose of the two Ferrero submissions appears to be to place its product (Nutella®) in an existing or new food category (either marmalades or a new category) with a one (1) tablespoon serving size. SFA believes that public comments and the data do not support either req uest. 1 The NLEA, This Docket and Specialty Foods Through its November 2, 2016 request for information and comments, FDA is asking for information and data about two issues of interest to SFA: the appropriate reference amount customarily consumed and the product category for flavored nut butter spreads. Although it did not ask for specific comments, FDA noted the Citizen Petition, which requests that FDA issue guidance recognizing that nut cocoa based spreads should fall within the "Honey, jams, jellies, fruit butter, molasses" category for the purpose of RACC determination or establish a new category for "Nut Cocoa Based Spreads" with a one (1) tablespoon RACC. The narrow issue in this Docket is the proper RACC for nut butter spreads and products. However, a preliminary question underpinning it (and the Citizen Petition) is the proper food category for nut butter spreads and products and for the Citizen Petition product. The Nutrition Labeling and Education Act (NLEA) requires nutrition information on marketed foods, including a serving size that "reflects the amount of food customarily consumed" (the RACC) and is expressed in a common household measure that is "appropriate to the food". 2 1 The 2016 Codex Alimentarius General Standard for Food Additives contains separate categories for processed fruit (including jams, jellies and marmalades), and confectionery (including cocoa-based spreads, including fillings) The product definition is "Jams, preserves and conserves are thick, spreadable products prepared by boiling whole fruit or pieces of fruit, fruit pulp or puree, with or without fruit juice or concentrated fruit juice, and sugar to thicken, and to which pectin and fruit pieces may be added. Jelly is a clear spreadable product prepared similarly to jam, except that it is has a smoother consistency and does not contain fruit pieces. Marmalade is a thick spreadable fruit slurry prepared from whole fruit, fruit pulp or puree (usually citrus), and boiled with sugar to thicken, to which pectin and fruit pieces and fruit peel pieces may be added.38,40 Includes dietetic counterparts made with non-nutritive high-intensity sweeteners. Examples include: orange marmalade, grape jelly, and strawberry jam. CODEX STAN 192-1995 (rev. 2016) 2 The FDA regulations governing nutrition labeling are at 21 C.F.R. 101.9. 21P a g e "The reference amount is based on the major intended use of the food", giving a common reference amount to foods with "similar dietary usage, product characteristics, and customarily consumed amounts". 3 The RACC is the basis for determining a serving size. It is undisputed that the appropriate household measure for nut butter spreads and products is "tablespoon". To comply with the NLEA, FDA issued a rule in 1993 defining RACCs for specific product categories. 4 Regarding the proper food category for the product in the Citizen's Petition, FDA determined that it and other nut cocoa based spreads were not commonly consumed in the U.S. and were not included in the food consumption data consulted by FDA. FDA placed it in the category "Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow cream, nuts, dairy and non-dairy whipped toppings with a RACC of 2 tablespoons".5 The recent 2016 FDA list of RACCs leaves Nutella® in the dessert topping category with a two (2) tablespoon RACC, in spite of Ferrero's 1994 Citizen Petition requesting a change and its 2014 comments in this Docket. Insufficient Data for a Change in RACCs SFA believes that there is insufficient data on the record to support a change in the RACC for flavored nut butter spreads and products or to change the product category and serving size for the product in the Citizen's Petition. RACCs are based on scientifically grounded data, including consumer surveys and consumption data. Regarding product category, the Citizen's Petition and Ferrero's August 1, 2014 comments to this Docket ask FDA to recognize that the consumption of Nutella® has changed and justifies changing the category and reference amount customarily consumed. The company's new "data" indicate that the product use has changed substantially. However, only 43 persons were in the referenced consumer survey which is barely above the 40-139 in FDA's intermediate range. The data presented by Ferrero is not based on a large enough sample size to give reliable estimates about new use and customarily consumed amounts. Previous studies also do not justify shifting nut butters like Nutella from the dessert toppings category. Additionally, the consumption data submitted are not comparable. The small cohort of consumers surveyed ate different amounts of the product. Some ate half tablespoon 3 The principles and factors used by FDA to determine RACC are at 21 CFR 101.12. The RACC values are listed in Table 2 of 21 CFR 101.12(b). 4+ The principles and factors used by FDA to determine RACC are at 21 CFR 101.12. The RACC values are listed in Table 2 of 21 CFR 101.12(b). 5 At that time Ferrero, which was then a member of the Specialty Food Association, had relied on its 1991 consumption survey and concluded that its product Nutella4'> is like chocolate syrup- a dessert topping with a RACC of 2 tablespoons. chocolate syrup- a dessert topping with a RACC of 2 tablespoons. This was based on Ferrero's survey that showed consumers used the product as a dessert topping. 3IPage measures while others ate full tablespoon measures. The data do not state how many persons were in each group. In short, the data submitted are unclear about requirements spelled out in FDA's rules: the suggested reference amount with full description of the methodology and procedures used, the intended dietary uses of the products and the names of the most closely related products. The information on the record in this Docket does not adequately support a new product category or RACC for flavored nut butter spreads and products or for the product in the Citizen's Petition, as even a brief review of the regulatory requirements illustrates.
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