jueves, 9 de marzo de 2017

FDA Law Blog: How to Name that Food: The Good Food Institute Petitions FDA for Clarity

FDA Law Blog: How to Name that Food: The Good Food Institute Petitions FDA for Clarity



Posted: 08 Mar 2017 05:55 PM PST
By Riëtte van Laack & Ricardo Carvajal –

With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue.

Although the issue is not limited to non-dairy “milks,” the debate has focused on these foods (e.g. soymilk, almond milk, etc.). In fact, for more than two decades, there has been a debate about including the word “milk” in the name of plant-based non-dairy products. About twenty years ago, in 1997, the soy industry submitted a Citizen Petition asking FDA to issue a regulation recognizing that the name “soymilk” is an appropriate “common or usual name” that had become established through common usage. To date, FDA has not made a determination on this Petition. Meanwhile, the dairy industry has continued in its efforts to persuade FDA to prohibit the use of the word “milk” in the name of plant-based “dairy alternatives,” arguing that these products are not “milk” as that term is defined in FDA’s regulation establishing a standard of identity for milk.

In 2008 and 2012, FDA issued Warning Letters (here and here) that included comments stating that the agency does “not consider soy milk to be an appropriate common or usual name for a product that does not contain ‘milk’” as defined by the standard of identity for milk.  Yet, just last year, FDA specifically allowed Hampton Creek to keep the name “Just Mayo” for an eggless, plant-based product that does not contain eggs as defined by the standard of identity for mayonnaise.

Thus far, Courts seem to have sided with the non-dairy industry. False advertising class action lawsuits targeting use of the terms almond milk and soymilk have not been successful. In a December 1, 2015 decision, the District Court dismissed the case alleging that Trader Joe’s has misled consumers and violated FDA standards of identity when it used the term soymilk on food. Gitson v. Trader Joe’s Co., 13-cv-01333, Doc. 139 (N.D. Cal., Dec. 1, 2015) (here); Ang v. WhiteWave Foods Co., 2013 WL 6492353 (N.D. Cal., Dec. 10, 2013) (here).

However, in December 2016, Reps. Mike Simpson and Peter Welch, and 30 cosigning members of the House urged FDA to more aggressively police the improper use of dairy terms used on labels of plant-based products that do not contain dairy products. The Congressmen asserted that it “is misleading and illegal for the manufacturers of these [foods] to profit from the ‘milk’ name.” In January, 2017, more fuel was added to the fire by the introduction of the DAIRY PRIDE Act (an acronym for the “Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday Act”) by Sen. Baldwin. This bill proposed to amend the Federal Food, Drug, and Cosmetic act to include a provision that a product is misbranded “[i]f it uses a market name for a dairy product . . . and the food does not meet the criterion for being a dairy product.” The bill defines dairy product as a food that “contains as a primary ingredient, or is derived from, the lacteal secretion . . . obtained by the complete milking of one or more hooved mammals.”

In response, the Good Food Institute (GFI) started a campaign, encouraging people to voice their opposition to the DAIRY PRIDE Act by signing a petition to Congress to “Dump” the DAIRY PRIDE Act. The American Soybean Association and the Soyfoods Association of North America (SANA) responded by writing members of the Senate Health, Education, Labor and Pensions Committee to object to the DAIRY PRIDE Act. In addition, SANA sent a letter to FDA arguing in support of the term “soymilk.”  Among other things, SANA points out that “the term soymilk has now been incorporated into government regulations for nutrition assistance programs, federal dietary guidelines, USDA data bases, and communications including but not limited to the Dietary Guidelines for Americans, National School Lunch Program, the Women, Infants, and Children program, and ChooseMyPlate.”

At the end of January, two new consumer class actions regarding the naming of non-dairy “milks” were filed. Kelley v. WWF Operating Co., 17-cv-117 (E.D. Cal., filed Jan. 24, 2017) (here); Painter v. Blue Diamond Growers, BC 647816 (Los Angeles Super. Ct., filed Jan. 23, 2017) (here). In complaints against Blue Diamond Growers and WhiteWave Foods, Plaintiffs have taken a new approach and assert (among other things) that they have been misled into believing that the plant-based “milk” was nutritionally equivalent to or better than cow milk when the products actually lack many of the essential nutrients and vitamins provided by cow’s milk. Citing FDA regulations, plaintiffs argue that the plant-based product should have been labeled “imitation.”

On March 2, 2017, GFI filed a Citizen Petition asking that FDA issue regulations that clarify how to name foods. Unlike the Petition by the soy industry in 1997, GFI’s Petition is not limited to “milk” alternatives and does not provide a definition or standard for certain terms. Instead, GFI requests that FDA amend 21 C.F.R. § 102.5, the regulation describing the principles for the common or usual name for nonstandardized foods, to include a provision that addresses the naming of a food by referencing the name of another food. GFI further asks that, in the interim, FDA issue guidance clarifying that foods may be named by referencing names of other foods consistent with the proposed amendment to the regulation. Similar to the 1997 Petition regarding soymilk, the GFI Petition provides a large number of examples of other foods in which FDA has allowed the use of a name that is defined by a standard of identity modified by another term, e.g., bread (defined as made from wheat) vs. rye bread, butter (defined as made from cream/milk) vs. peanut butter and apple butter, and noodles (defined as ribbon shaped products made from wheat flour that must contain egg products) vs. rice noodles. Although the Petition counters the allegations that the plant-based products are imitation products, and therefore must be labeled as such, GFI does not request that FDA amend that regulation.

We’ll continue to monitor developments in the legislative, administrative, and judicial arenas with respect to this rapidly evolving issue.