About the Author(s)
Recent Developments
U.S. Food and Drug Administration Declines to Advise Judges on the Definition of "Natural" Foods
Maris Brancheau


Abstract: The Federal Drug Administration (“FDA”) declined to issue guidance in pending litigation related to consumer claims that "natural" food labels were misleading. Specifically, courts asked the FDA whether products could be labeled "all natural" or "natural" when they contain synthetic ingredients or genetically modified organisms. The agency formally declined to advise the judges and wrote that such a determination could only take place following a thorough public vetting, for which the agency has stated it lacks the time and resources to make a priority.1 The ongoing trend in litigation by consumers against food manufacturers in relation to natural labels is summarized.

Keywords: GMOs, Natural, FDA, Labels

Published: August 6, 2014
Cite as:
Brancheau, M., U.S. Food and Drug Administration Declines to Advise Judges on the Definition of “Natural” Foods, Bull Health Pol’s & L., 2014; 3(1).

Introduction
The Food and Drug Administration (“FDA”) has declined to define the term "natural" in the context of three lawsuits against food manufacturers who use the term on packaging even though their products allegedly contain Genetically Modified Organisms (GMOs), or other ingredients that do not occur normally in nature, such as additives and chemical food dyes. Three district court judges asked the FDA to weigh in on the definition of natural and stayed the cases in the interim. The FDA declined to become involved in the litigation.2 Meanwhile, the Grocery Manufacturers Association has notified the FDA that the interest group intends to petition the agency to allow products containing GMOs to be labeled as natural.3

Issue:

Consumers who feel duped by labels that declare a food product to be "natural" or "all natural" are filing lawsuits to hold the food manufacturers responsible for deceptive advertising. Often times these food contain genetically- modified ingredients or additives that consumers do not consider to be natural. Currently, except for in the state of Vermont, food manufacturers do not have to identify if their products contain GMOs. A rash of recent lawsuits by consumers claiming food manufacturers engage in deceptive advertising or violate unfair competition laws when they label products containing GMOs or chemical additives as "all natural" has led several judges to ask the FDA for clarification on the official definition of "natural." In January of 2014, the FDA declined to issue a definition in the context of the legal battles.

Genetically Modified Organisms are defined as "material that has been altered at the molecular or cellular level by means that are not possible under natural conditions or processes (including recombinant DNA and RNA techniques, cell fusion, microencapsulation, macroencapsulation, gene deletion and doubling, introducing a foreign gene, and changing the positions of genes), other than a means consisting exclusively of breeding, conjugation, fermentation, hybridization, in vitro fertilization, tissue culture, or mutagenesis."4

Two federal judges in California and one in New Jersey stayed proceedings in cases related to "all natural" claims and asked the FDA for an official advice letter.5 On January 6, 2014, the FDA responded to the courts' request for administrative direction. The courts asked the FDA to help determine if food labels were fraudulent when plaintiffs claimed the "natural" and "100% natural" labels were misleading "because the products contain corn grown from bioengineered, genetically modified seeds." The FDA declined to offer its opinion to the courts.7

The FDA determined a public input process would be necessary before any formal definition of "natural" could be made by the agency. The FDA also noted that its limited resources geared toward food safety and programs mandated by Congress were a priority and could not turn resources toward this debate about what is "natural”. The letter to the judges noted, "The FDA has not promulgated a formal definition of the term "natural" with respect to foods. The agency has, however, stated that its policy regarding the use of the term "natural" on food labeling means "nothing artificial or synthetic (including all color additives regardless of source) has been added to a food that would not normally be expected to be in the food."8

The FDA has formally declined to make "a determination regarding whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled natural.9

In the wake of the FDA's decision to stay out of the current litigation, the food industry is bracing for more lawsuits related to "natural" claims and the Grocery Manufacturers Association has officially petitioned the agency to allow food products containing GMOs to be labeled as natural.10

The stakes are high as consumers continue to bring many class-action suits claiming food manufacturers are being deceptive in using the term "natural" on products that contain ingredients that do not naturally occur in the environment, such as preservatives and certain dyes. Gruma Corp. is currently being sued for using the term "natural" on its Mission tortilla chips. Naked Juice, owned by PepsiCo, paid $9 million to settle similar claims against it last year.11

Trader Joe's Co., in early 2014, agreed to a $3.375 million settlement to a class- action suit over "natural" claims on a variety of its products that contain allegedly synthetic ingredients.12 The FDA has said that "synthetic" ingredients fall outside the scope of its definition of natural.13 Trader Joes denied any wrongdoing but agreed to the settlement proposal that may be approved in U.S. District Court for the Northern District of California this summer. The maker of PopChips also agreed to a $2.4 million settlement.14

A trend in lawsuits over "natural" claims continues. In 2011, 49 class-action suits were filed. In 2012 the number was 85 and in 2013 the number dropped to 58.15 California, long known as a consumer's rights state, is at the forefront of the “natural” litigation.16 With the FDA's refusal to define natural in the context of current litigation, it appears the cases against "Big Food" will likely continue in the near future.

Conclusion
As consumers continue to seek redress from courts in their battle for fair labeling of food products, the bench is left without the formal advice of the FDA as to how to define "natural" in the context of food products. Even as grocery manufacturers lobby the FDA to define GMOs as "natural" and courts have sought input from the FDA on what "natural" should mean on food labels, no clear definition has evolved.

In the meantime, consumers are taking their claims to court and food manufacturers are responding to the growing litigation by either sourcing ingredients that are not genetically modified or by removing the term "all natural" from their packaging (usually in response to litigation and as part of settlement terms). Regardless, the number of new products labeled with the "natural" claim continues to rise. 17

Competing Interests: None reported.

Acknowledgements
Gayle Blatt, Esq., partner in the San Diego law firm of Casey Gerry Schenk Francavilla Blatt & Penfield LLP, introduced the author to the topic during a Health Law Society Spring 2014 speaker panel at California Western School of Law.

Author(s)
Maris Brancheau is a third-year student at California Western School of Law. She is a member of the Environmental Law Society and a Trustees' Scholar. Prior to attending law school, Ms. Brancheau worked for nine years as a journalist after graduating magna cum laude from Aquinas College in Grand Rapids, Mich.

References (Bluebook)

1Letter from Leslie Kux, Assistant Commissioner for Policy, Department of Health & Human Services, to Honorable Yvonne Gonzalez Rogers et al., 2 (Jan. 6, 2014), available at: http://ofwlaw.files.wordpress.com/2014/01/doc-70-letter-re-cox-v-grumpa-corp-01062014.pdf

2See Cox v. Gruma Corp., No. 4:12-CV-6502-YGR, 2013 WL 3828800 (N.D. Cal. July 11, 2013) Barnes v Campbell Soup Co., No. 3:12-CV-05185-JSW (N.D. Cal. Feb. 21, 2014); and In Re General Mills, Inc. Kix Cereal Litigation, No. 2:12-CV-00249-KM-MCA (D.N.J. November 2013). (Referrals to The United States Food and Drug Administration).

3Cookson Beecher, Grocery Manufacturers Want Food with GMOs to Be Labeled as “Natural,” Food Safety News (March 1, 2014, 3:05 p.m.), http://www.foodsafetynews.com/2014/01/grocery-manufacturers-want-foods-with-gmos-to-be-labeled-as-natural/#.UxJnZxyBNI8.

4Genetically Engineered Technology Farmer Protection Act, H.R. 6637, 110th Cong. § 102. (2008).

5Supra note 2.

6Supra note 1.

7Id.

8Id. citing 58 Fed. Reg. 2303, 2407 (1993).

9Supra note 1 at 2.

10Supra note 2.

11Loren Israelsen and Frank Lampe, Litigation Now Driving the Non-GMO Labeling Discussion,Natural Products Insider (Oct. 2, 2013), http://www.naturalproductsinsider.com/articles/2013/10/litigation-now-driving-the-non-gmo-labeling-discu.aspx.

12Settlement proposed for Trader Joe’s ‘natural’ claims lawsuit, Supermarket News (Mar. 6, 2014), http://supermarketnews.com/laws-amp-regulations/settlement-proposed-trader-joe-s-natural claims-lawsuit.

13Supra note 1.

14Final Judgment and Order of Final Settlement Approval and Dismissal with Prejudice, filed in Kelly v. POPCHIPS, Inc., No. 1316-CV11037 (March 13, 2014), https://popchipssettlement.com/mainpage/CourtDocuments.aspx.

15Elaine Watson, Have All-Natural Lawsuits Peaked and What Defense Strategies are Working, FOOD Navigator USA (Feb. 21, 2014), http://www.foodnavigator-usa.com/Regulation/Have-all-natural-lawsuits-peaked-And-what-defense-strategies-are-working.

16Id.

17Elaine Watson, Is the Food Industry Falling Out of Love with 'Natural' Claims? Not According to the Data, says Mintel, Food Navigator USA (Feb. 21, 2014), http://www.foodnavigator-usa.com/Markets/Is-the-food-industry-falling-out-of-love-with-natural-claims-Not-according-to-the-data-says-Mintel.



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