FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for November 2016

Posted on Tuesday, November 8 2016 at 7:55 pm by -

“Nutella” No Longer Just a Dessert Topping – FDA Seeks Comments on Appropriate Reference Amount Customarily Consumed (RACC) and Product Category for Flavored Nut Butter Spreads

By: Carolina M. Wirth

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]

8a17fd49-134d-408a-a1e4-668c1200a01bMoving 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]


Read the rest of the entry…