U.S. FOOD AND DRUG ADMINISTRATION DOCKET NO. FDA-2009-D-0430

Transcription

1 U.S. FOOD AND DRUG ADMINISTRATION DOCKET NO. FDA-2009-D-0430 JOINT COMMENT ON DRAFT GUIDANCE FOR INDUSTRY: INGREDIENT DECLARED AS EVAPORATED CANE JUICE MAY 5, 2014

2 May 5, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD Re: Docket No. FDA-2009-D-0430; Draft Guidance for Industry on Ingredients Declared as Evaporated Cane Juice Dear Sir or Madam: The entities and associations supporting this joint comment very much appreciate the opportunity to respond to the questions relating to the ingredient evaporated cane juice that were raised by FDA in the Notice published in the Federal Register on March 5, 2014 (the Notice ). In an effort to provide a single comprehensive response to the Notice as well as to the underlying Draft Guidance published on October 7, 2009 this joint comment is being submitted by the following eleven stakeholders spanning across several relevant industries, including (i) sweetener manufacturers and suppliers (i.e., Domino Foods, Inc., Florida Crystals Food Corporation and Wholesome Sweeteners, Inc.), (ii) food manufacturers (i.e., Amy s Kitchen, Inc., Chobani, LLC, Clover-Stornetta Farms, Inc., KIND LLC, Late July Snacks LLC, and Pacific Foods of Oregon, Inc.), and (iii) trade associations representing hundreds of other entities (i.e., the Grocery Manufacturers Association (GMA) and International Dairy Foods Association (IDFA)). At the outset, we wish to make clear that we understand the primary basis for FDA s issuing the 2009 draft guidance: a documented concern about misrepresentations in juice labeling regarding the percentage of juice in a given product (an area of labeling governed by 21 CFR 101.3). We agree completely that the terminology evaporated cane juice does not identify an ingredient that can lawfully be declared comprising, in whole or in part, a percentage of juice in a given beverage product. Our concern, however, is that in seizing upon the term dried cane syrup as a substitute common or usual name, the agency was unaware of the long history in the sweetener industry of the words evaporated, juice, and cane and the fact that, together, the words serve to clearly and accurately communicate the basic nature of an ingredient that is distinguishable from other ingredients derived from cane. As will be clear after review of the attached comment and supporting statements and documentation, while the term dried cane syrup has no history of use in the industry and virtually no recognition among consumers, the term evaporated cane juice is wholly consistent with a product produced from a stage of the manufacturing process and has characteristics that differ from a substance such as dried cane syrup (if such a substance in reality existed) as well as other forms of cane-based sweeteners ranging from sugar to turbinado sugar, to demerara sugar, to molasses. The companies have no question that FDA arrived at its suggested alternative common or usual name (i.e., dried cane syrup) in a good faith effort to help ensure truthful percentage juice declarations on the labeling of beverage products. That said, however, by failing to recognize the history of the use of the terms evaporated, juice, and cane in the sugar industry and the fact that those terms serve to describe the basic nature of the ingredient in a manner consistent with over 100 years of cane processing, FDA created the potential for a significant degree of chaos among sweetener providers, food manufacturers, retailers and consumers. The catalyst for creating the chaos that now affects the industry was not any enforcement action by the agency but, rather, aggressive litigation by the class action bar to use and rely upon the 2009 guidance as

3 Division of Dockets Management (HFA-305) Food and Drug Administration May 5, 2014 Page 2 a tool to privately enforce a tentative, non-binding agency assessment that, as we show in this comment, is regardless of how well-intentioned, flawed. As described in detail in the joint comment, the name evaporated cane juice finds its root in industry practices followed as early as the mid-19th century and over the last 25 years has been used by manufacturers to describe the ingredient. The sweetener manufacturers and suppliers have sold millions of tons of evaporated cane juice to food manufacturers, and thousands of different products listing evaporated cane juice as an ingredient were sold to consumers. In all, we estimate that well over 1 billion products listing evaporated cane juice on the label have been sold to consumers, and consumers have also purchased millions of pounds of evaporated cane juice directly from the sweetener suppliers and retailers. FDA s March 5, 2014 Notice reopening the comment period on the 2009 draft guidance provides the welcomed opportunity to bring an orderly resolution to the evaporated cane juice labeling issue. Some courts have already dismissed or stayed pending litigation, deferring to FDA s authority over this food labeling question. Unfortunately, not all courts have done so, and plaintiffs counsel in the dismissed and stayed actions are waiting for FDA to act before deciding whether to revive their lawsuits on this issue. In light of the importance of this issue to the group submitting this joint comment and to the industry as a whole the companies supporting this comment have accumulated a substantial amount of data and information showing that evaporated cane juice is the common or usual name of the ingredient under 21 C.F.R For example, we have asked a leading consumer survey expert (who has worked with both FDA and FTC in the past) to design and implement a consumer survey; we have collected thousands of product labels identifying the evaporated cane juice ingredient; we have asked other experts to submit statements about the process for manufacturing cane-based sweeteners and the usage of the terms evaporated cane juice and dried cane syrup ; we have obtained statements from individuals with relevant knowledge about the matters underlying FDA s review of this labeling issue; and we have collected substantial amounts of other data and information, including product samples, for FDA s review and analysis. For the reasons set forth herein and as supported by all of the exhibits submitted concurrently with this joint comment we respectfully request that: (1) FDA issue final guidance declaring evaporated cane juice as the common or usual name of the ingredient, (2) regardless of the chosen name (including if it is evaporated cane juice ), FDA set an effective date of no earlier than one year from the date of the final guidance to permit time for companies to conform their labels, and critically (3) FDA confirm that until the effective date, FDA will not consider products to be misbranded if they identify the ingredient on product labels as a form of cane juice (including evaporated cane juice ), cane sirup (including dried cane syrup ), or cane sugar.

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