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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. The consumer comments in the Docket are important but are not joined by formal surveys and data.

Nutrition Labels and Informed Consumers The U.S. nutrition label information is based on a serving size for a product. The serving size is intended to provide the basis for giving consumers nutrition information based on the reality of how much of a food we eat at each eating occasion. 6 If, for example, Nutella and peanut butter have the same major intended use, "similar dietary usage, product characteristics, and customarily consumed amounts", then they should have the same RACC and serving size for purposes of consumer information and comparison.

Dietary Usage Regarding dietary usage, the majority of consumer comments to this Docket say that nut butter spreads like Nutella® now are used as a spread. The product may still be used as a dessert topping, but apparently often with a larger than two {2) tablespoons RACC. Few consider nut butters in the same category as jams and preserves. These reports from consumers are reflected in the food categories used by the U.S. and several other countries, including those in the European Union and Canada? From consumer comments

6 The U.S. nutrition label does not include an additional numerical reference for serving size. This is different from the 100 gram and 100 milliliter reference amounts used in the European Union and Canada, for example. See, Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision offood information to consumers. Canadian nutrition labels list serving sizes in a common household measure, like the United States, and also lists serving sizes by grams or milliliters. Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), P.C. 2016-1080 December 2, 2016. The 100-gram reference amount adopted by other countries simplifies consumers' ability to compare how different but competing products fit into their daily diet. That reference amount is a constant basis for comparison, whatever the serving size. "Serving size is not necessarily the suggested quantity of food you should eat. The serving size tells you the quantity of food used to calculate the numbers in the nutrition facts table. By checking a product's serving size, you can: understand how much of a nutrient you are eating, compare calories and nutrients between 2 similar packaged food products, compare it to the amount you actually eat." Serving size, http://www.healthycanadians .gc .ca/eating-nutrition/label­ etiquetage/understanding-comprendre/serving-portion-eng.php

7 This consumer view is like that of international standards, which distinguish between spreads (in the confectionery category) and peanut butter (in the preserved vegetables category). Canadian regulations 41 Page included in the Docket nut butters are used as spreads like peanut butter or sometimes, in the case of Nutella®, like a dessert topping.

Product Characteristics In terms of product characteristics, nut butters like almond butter, hazelnut butter and cashew nut butter are more like peanut butter than like a dessert topping. They are very different from a jam or marmalade. The raw materials and appearance of nut butters and dessert toppings differ, although all may have a similar consistency. Nut butters and marmalades are the product of different production processes and often require different storage methods. They have different nutritional values. Consumers choose them for different purposes and for different eating occasions. These product characteristics influence the marketing of the products, not only the type of market but also placement in the market, thereby adding another level of differentiation.8

Customarily Consumed Amounts The customarily consumed amounts are key to important nutrition information for consumers and to a food's serving size. For this Docket an issue is whether the customarily consumed amount for nut butters is two (2) tablespoons. SFA believes that it is. If FDA continues to consider Nutella® as a dessert topping, no data has been presented to change the customarily consumed amount from two (2) tablespoons.

No Need for New Category The Citizen's Petition asked that FDA establish separate serving amounts for "nut cocoa spreads" and "other nut spreads (like peanut butter or almond butter)''. When a Citizen Petition is for a new subcategory of food with its own reference amount, the Petition must also address data (from the same survey data) that demonstrate that the new subcategory of food will be consumed in amounts that differ enough to warrant a separate reference amount, including mean, standard deviation, median and mode consumed per eating occasion for the product and other products in the category. There are other requirements about the supporting data. For example, the sample size should be large enough to give reliable estimates for customarily consumed amounts.

Conclusions

The Specialty Food Association, as the trade association for many small and very small food businesses that produce nut butters, jams and marmalades, and dessert toppings is greatly include a Nuts and Seeds category for "Peanut butter, nut butters and substitutes, such as coconut and soya butter" with a 15-gram Reference Amount, which is to be made into the appropriate number of tablespoons. The category Sugars includes Honey, molasses and bread spreads with a 20-gram Reference Amount (US) and Jams, jellies, marmalades, fruit butters and spreads with a 15 ml Reference Amount (U9). There is a separate sub-category for Syrups used as toppings, such as pancake syrups, maple syrup, fruit syrups and ice cream sundae syrups with a reference amount of 60 ml. http://www.healthycanadians.gc.ca/eating-nutrition/label­ etiquetage/regulatory-guidance-directives-reglementaires/reference-amounts-food-quantites-reference­ aliments/guide-eng.php#o

8 See, e.g .. , Product Characteristics and Idea Generation, http://www. nz ifst.org.nz/creati ngnewfoods/idea_generation 5. htm

S I P age interested in this Docket. Based on the information available, SFA believes that all flavored nut butter spreads should have the same reference amount and a two (2) tablespoons serving size.

Regarding the Citizen's Petition and consumer comments in this Docket, SFA recognizes that consumers' eating occasions for Nutella® have changed. However, because the data provided by Ferrero to verify the change and the appropriate RACC are insufficient, SFA supports keeping Nutella in the dessert toppings product category with a RACC of two (2) tablespoons. If FDA decides that a change is needed, it might consider including Nutella in the same category as peanut butter and other nut butters.

SFA would be pleased to provide additional information to FDA about this Docket, to meet and to answer questions.

Thank you.

Sincerely, PW~ Philip Kafarakis President, Specialty Food Association

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