As we previously reported, the Food and Drug Administration (FDA) issued a Final Rule in May of this year updating, modifying and establishing several reference amounts customarily consumed (RACCs) for a number of foods based on new consumption data showing that the amount of food consumed by Americans has changed since 1993.  In that Final Rule, the Agency recognized the need for a RACC for hazelnut spreads “outside of the dessert product category” and agreed that the “primary usage of hazelnut spread is as a spread for bread instead of as a dessert topping.”[1]  At the time, because the proposed rule did not address this issue, and because the Agency intended to provide an opportunity for the public to comment, FDA noted that it intended to “consider whether to move hazelnut spread to a different appropriate product category in a future rulemaking.”[2]

Moving forward with that intent, on November 2, 2016, FDA started the rulemaking process by establishing a docket to receive comments, data, and other information on the appropriate RACC amount and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) and products that can be used to fill cupcakes and other desserts, such as cakes and pastries.  In the Federal Register Notice, FDA noted that it was taking this action for two reasons: (1) the Final Rule updating certain RACCs, and (2) a Citizen Petition asking the Agency to either “issue a guidance recognizing that “nut cocoa-based spreads” fall within the “Honey, jams, jellies, fruit butter, molasses” category for purposes of RACC determination; or amend the regulation to establish a new RACC category for “nut cocoa-based spreads’ with an RACC of 1 tablespoon (tbsp.).”[3]  FDA also took this action in response to a request to establish a RACC and product category for cupcake filling.[4]

In the Request for Comments, FDA discusses the Citizen Petition, which included data pertaining specifically to Nutella^®, including results from consumer usage surveys that found that “on average 74 percent of “Nutella” use was associated with spreading the product on bread, including toast and in making sandwiches and that two percent of use was as a topping for ice cream.”[5]  The Agency also discusses data that appears to support an RACC of 1 tablespoon for Nutella^® and other similar products.[6]

Finally, FDA is also seeking comments with regard to establishing a RACC for icing intended for use as cupcake filling. The Agency had previously recognized the “need for an RACC for this specific food product as well as for other types of cake or pastry fillings” in the May 2016 Final Rule, but wanted to provide the public with an opportunity to comment on this specific issue prior to addressing the issue in a future rulemaking.[7]

In addition to inviting persons to generally comment on the appropriate RACC and product category for flavored nut butter spreads and products used for cupcake fillings, the Agency is also seeking data and information in response to the following specific questions:[8]

• What additional data and information are available to determine the customary consumption amounts of and appropriate product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)?
• What is the major intended use of flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)?
• What other products on the market, if any, are similar to flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)? What product characteristics make these products similar? What dietary usage makes these products similar? Which product categories do flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) compete with or take market share and volume from? What data and information are available regarding the customary consumption amounts and product category for these similar products?
• What additional data and information are available regarding the customary consumption amounts and product category of products used as fillings for cupcakes and other desserts, such as cakes and pastries?
• What is the major intended use of fillings for cupcakes and other desserts, such as cakes and pastries?
• What other products on the market, if any, are similar to cupcake filling, such as cakes and pastries fillings? What product characteristics make these products similar? What dietary usage makes these products similar? Which product categories do fillings for cupcakes and other desserts, such as cakes and pastries, compete with or take market share and volume from? What data and information are available regarding the customary consumption amounts and product category for these similar products?

Comments must be submitted to FDA on or before January 3, 2017.  You may submit your comments here.

[1] See 81 Fed. Reg. 34,000 at 34,029 (May 27, 2016).

[2] Id.

[3] See 81 Fed. Reg. 76,323 (November 2, 2016).

[4] Id.

[5] Id. at 76,324.

[6] Id.

[7] Id. at 76,325.

[8] Id.